Manufacturing & Production

Dyne Therapeutics

Director, QA GMP Operations

**Company Overview:**

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at [https://www.dyne-tx.com/](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DaBhdU0rLyxqDF5MLc_hIfw7usSG4P5AlGZUt689alyH6v7mzOmFdpd9s5X8DlnvZSiEkR5UEisX91xRDuQTa2VgG02ByJmFzR8fXOPz8Zi8%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825271389%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=J6tnBKJnocuFhoQSNnLD03mlmX8CCP4Ufz89Tz2BRqY%3D&reserved=0>), and follow us on [X](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DLBKooGRVe4UrE2Sa6ReueOswzx2nXn5X8MuiTcNNQ_6lX0cFP8Xf24jpFASx3QmF9Qt-1g3RGsigqX34LIiwMg%3D%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825316922%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1SaJTlzgJLAz3INco8zVJpHByglVu9H3uR4eaUUwqbY%3D&reserved=0>), [LinkedIn](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DV9e03kLdDWSbh0_VwnuvS9iTb21RRXsSKiAaMEbducMXKsrR2S-Gw7FLuap5gHCzvcaUIvGPyAeg1wRzFGrqW9J_Z6Ha8bGtJaWV9voKp-c%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825339609%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=bDmOn9uD5vB9%2F2LttEyLg%2BANoH6v3vDFv7SAwVdi%2BoI%3D&reserved=0>) and [Facebook](<https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DCMyzCcuOkxGNqTNEki-upZwJJPBCJLp0a-MvjKwwfPo1XQp8XutL02Vy2Vg3ZmpnCYnPLhHxcgEzFeh-07gg_rWzXbiw64-AClVkXbKyKQs%3D&data=05%7C02%7Cjinna.oh%40dyne-tx.com%7C0a9e83cf0dad4bb9d7f808defa05885d%7Cebfdf398d6a6477eace4f79a019fa3aa%7C0%7C0%7C639223098825359448%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=exQuTFG7FGBX1V0XPy4zSebLvhQUDksB19Nej8Eg3DQ%3D&reserved=0>).

**Role Summary:**

The Director of QA GMP Operations is responsible for management of GMP quality within our external manufacturing operations globally and internal GMP operations for development and commercial programs. The Director will also work closely with internal business stakeholders as well as internal Quality function to deliver outcomes to advance programs within compliance. The Director is responsible for oversight of QA activities and ensuring the quality of deliverables within the role's purview.

This is an onsite role based in Waltham, MA.

**Primary Responsibilities Include:**

- Management of external quality operations in support of GMP manufacturing (clinical and commercial) activities.
- Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines.
- Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs.
- QA support of Tech Transfer and Process Validation activities.
- Disposition of GMP batches and interfacing with the Qualified Person (QP).
- Change management to ensure proper evaluation of manufacturing and testing related changes by Quality, Regulatory, and Subject Matter Experts.
- Manage CDMO performance within Quality Agreement expectations and GMP compliance.
- Drive continuous improvement and inspection readiness.
- Collaborate cross functionally to ensure pre-approval inspection and commercial readiness activities are completed at the CDMOs and internally.
- Adjudicate on compliance discussions and negotiate any required corrective actions.
- Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.

**Education and Skills Requirements:**

- Minimum of a BA/BS degree
- Minimum of 10+ years of experience in GMP Quality Operations in a clinical late stage and/or commercial biotechnology company
- Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources without direct authority
- Experience implementing and utilizing various outsourcing and support models
- Experience with disposition of product batches and interfacing with a Qualified Person (QP)
- Excellent written and oral communication skills, including well-developed presentation skills
- Excellent organizational skills and ability to manage multiple priorities
- Strong collaboration and interpersonal skills to effectively interact with internal or external stakeholders at all levels in the organization
- General business management knowledge to assess the impact of project decisions on financial and corporate objectives
- Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities
- Embrace Dyne’s core values and culture

\#LI-Onsite

MA Pay Range

$188,000 - $230,000 USD

The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

*Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.*

Massachusetts

Boston BioProducts

Process Development Associate

As Boston BioProducts continues to grow, we are expanding our Process Development (PD) team and are seeking a Process Development (PD) Associate. This role is instrumental in supporting new product introductions by ensuring products meet customer specifications and quality expectations. The PD Associate will also evaluate the feasibility, scalability, and accuracy of products and processes while driving continuous improvements that enhance efficiency, consistency, and overall quality. As we continue to scale, this position plays an important role in maintaining the high standards our customers expect.

This is a 100% (Mon-Fri) onsite role in Milford, MA - LOCAL CANDIDATES ONLY

\*\*Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters.

Responsibilities:

- Calculate, perform, verify and review chemical product formulations
- Onboards new products following BBP procedures and standards (documentation, feasibility, scalability, consistency, and verification)
- Generates manufacturing batch records and translates customer requirements into technical instructions for manufacturing
- Create pilot, verification, and investigational batches
- Assist in performing investigations for complaints, verification or new procedures
- Draft, review and update SOPs, Work Instructions, Memos, Safety Data Sheets, etc.
- Communicate with clients and vendors to ensure timelines and projects are completed.
- Forecast and provide minimum quantities of raw materials, chemicals and consumables.
- Calibrate, qualify, validate, and perform preventative maintenance on equipment
- Review previous processes, SOPs, and procedures for potential improvement
- Training staff in new procedures, equipment usage, lab and chemical safety
- Ensuring that all products are properly discarded in accordance with the Safety Data Sheet
- Work on new projects assigned by Process Development Manager as they arise

Education:

Bachelor's degree in Biology, BioChemistry or any related discipline

Experience:

Minimum of 2-3 years working in a GMP, ISO or manufacturing environment

Knowledge & Skills:

- Includes all Knowledge and Skills of a Process Development Associate I
- Ability to perform calculations for new and existing products
- Ability to meet deadlines, multitask, and change priorities while maintaining productivity
- Ability to coordinate internally and externally with BBP team members and clients to ensure project completion.
- Ability to work well independently and within a team

Physical Requirements:

- Stand and work in a lab environment for an extended period
- Ability to Lift and Transfer up to 25 pounds
- Work underneath a Biological Safety Hood for an extended period

Production Technician

As Boston BioProducts (BBP) continues to grow, we are looking for a Production Technician to join the BBP team. This hands-on role is responsible for supporting daily production operations and ensuring our products are manufactured consistently and to the highest quality standards. The successful candidate will thrive in a fast-paced lab environment, work independently with strong attention to details, and help maintain a safe, organized and efficient production area, including proper handling of chemicals, materials and equipment.

This is a 100% (Mon-Fri) onsite role in Milford, MA - LOCAL CANDIDATES ONLY

\*\*Direct Applicants ONLY - No Staffing Agencies or Third-Party Recruiters."

Roles & Responsibilities

- Performs general housekeeping in compliance with the standards required.
- Demonstrates a sound knowledge and understanding of GMP requirements.
- Demonstrates the care and safety necessary to properly safeguard facilities, equipment, product and co-workers.
- Perform and adhere to MFG protocols and batch records pertaining to filtration and assisting peers as needed.
- Assembles, cleans and operates production equipment (i.e. filters, pumps, pipettes, BSC, benchtop surfaces, etc.).
- Demonstrates GDP by performing real time documentation during production run and maintains accurate records/logs.
- Reviews documentation prior to completion of records
- Ensures daily/weekly tasks are completed in a timely fashion (i.e. track and stock consumable items, ensure proper storage of raw materials and buffers, delivery of QC samples, execution of proper disposal methods, etc.)
- Maintains up to date training records.
- Performs finished goods filtration and packing activities independently.
- Demonstrates understanding of beliefs, values and behaviors in accordance with company culture.
- Shows ability to train new technicians in finished goods filtration and packing activities.
- Shows understanding of buffer compositions, (ie. Molecular weights, concentrations and dilutions).
- Executes calibration, daily maintenance and operations of production equipment (i.e. pH and conductivity meters, Osmometer, SUMs, fume hood, etc.)
- Prepares buffer solutions and properly stores process intermediates.
- Able to independently manufacture in stock buffers
- Performs pH and buffer adjustments accordingly.
- Performs calculations for processing.
- Weighs all powders, chemicals, and reagents needed and performs all calculations, preparations and reagent additions.
- Recognizes and identifies mechanical, chemical, and safety hazards to the proper individuals.
- Capable of working in multiple roles associated with the manufacturing of solutions.
- Develop a better understanding of how to be supportive of new processes and initiatives.
- Create a company culture which is representative of company values.

Qualifications and Requirements

- Requires a High School Diploma or equivalent
- Minimum 1-2 years of relevant experience
- Fundamental knowledge of solutions and reagents, including properties, functional, application, and precaution
- Fundamental knowledge of chemistry concepts such as molarity, concentration, and mass.
- Fundamental knowledge with dimensional analysis for basic dilutions and conversions.
- Fundamental knowledge of ISO standards and other applicable regulations

BioMarin Pharmaceutical Inc.

(CW) Manufacturing Associate (Temporary/Contract)

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

Onsite Day Shift 6am to 7pm

Duties

PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT/PHYSICAL DEMANDS

• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.

• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.

• May require work around loud equipment. • The use of personal protective equipment will be required.

• Requires various shift based work and off hours.

Skills

• Strong communication skills—verbal and written

• Ability to work in a team environment which includes good conflict resolution and collaboration

• Displays good initiative to identify areas for improvement and implement solutions

Education

-Bachelor’s degree in science related area or engineering

-Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

PASTE JOB POSTING TEXT HERE

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

California

(CW) Manufacturing Associate (Temporary/Contract) Night Shift

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Onsite Night Shift Temporary

Duties

PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT/PHYSICAL DEMANDS

• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.

• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.

• May require work around loud equipment. • The use of personal protective equipment will be required.

• Requires various shift based work and off hours.

Skills

• Strong communication skills—verbal and written

• Ability to work in a team environment which includes good conflict resolution and collaboration

• Displays good initiative to identify areas for improvement and implement solutions

Education

-Bachelor’s degree in science related area or engineering

-Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

Reason for Request:

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Operations Manager, Global External Operations

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

**GEO Operations Manager**

As part of BioMarin’s TOPS group, Global External Operation (GEO) has responsibility for managing all external manufacturing operations and performance at Contract Manufacturing Organizations (CMOs).

The GEO Operations Manager is responsible for managing day-to-day activities at one or more CMOs. Operations may include drug product operations (biologics and/or small molecules) and/or finished-goods packaging. Both clinical and commercial activities are in scope for each area, as required

The role also supports operational readiness for new CMOs or new processing steps at an existing CMO. The successful candidate will partner with SMEs (both internally and with externally), as needed, to ensure quality product is delivered on time and in full.

**Key Responsibilities:**

- Execute with the CMO the production plan to deliver an uninterrupted supply of clinical & commercial product
- Manage the CMO meeting schedule in conjunction with your cross functional colleagues to ensure an engaging and collaborative environment.
- Identify any supply constraints and negotiate/resolve with the CMO any issues to meet the supply plan.
- Manage escalations and communications within the process team/GEO site from an operations perspective.
- Collaborate with a cross functional team to ensure uninterrupted supply of product. This will involve both process team and non-process team colleagues.
- Perform root cause analysis or equivalent to understand issues and implement corrective actions as appropriate.
- Manage material movement between CMO sites with various internal partners.
- Attend at CMO to monitor production campaigns and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
- Manage and maintain with cross functional team a visual metric/dashboard to provide an oversight of the GEO business.
- Coordinate as required BioMarin activities in the evaluation of process changes, change requests and deviations to ensure timely resolution without impacting on supply.
- Act as the focus and conduit for communications between the CMO and with members of BioMarin manufacturing group and other departments to meet the supply plan.
- Lead and/or participate in technology transfers, new product launches, validation activities with the CMO and internal cross functional teams including Process Development, Regulatory Affairs and Quality departments
- Contribute to the development of formal systems and procedures for the selection of CMO
- Initiate and implement necessary control systems within budget and to reduce cost of goods
- With the Corporate Compliance and Quality departments, ensure that the CMO is compliant with cGMPs.
- Support contracts and negotiations with CMO in collaboration with the procurement and EPM teams.
- Represent assigned product, CMO and GEO Ops team at appropriate meetings, e.g. VPT, VST.

Additional ORP focused responsibilities, (as required):

- Establish and maintain GEO’s processes and project templates for ORP management.
- Carry out Operations Gap Analysis of new CMOs and establish and lead subsequent mitigation plans.
- Ensure smooth transition of Operations activities from PPQ/Launch Phase into the Commercial Process Team.
- Lead site exit projects as required for GEO.

**EXPERIENCE & Skills:**

Minimum requirement of 5 years leadership experience in Operations, Supply Chain or Quality.

- BS/BA degree; life sciences, business, or supply chain management

Required skills needed to accomplish the responsibilities/essential functions include:

- Will have an excellent understanding of the processes/unit operations.
- Demonstrated ability in leading/managing cross functional, multi-disciplinary teams.
- Ability to guide and support cross functional teams in the resolution of short-term issues and sustained performance for long-term goals.
- Proven track records in effective decision making.
- A high level of initiative, influencing, coaching as well as excellent organizational skills.
- Experienced in working and managing in a regulated GXP environment.
- Strong stakeholder and relationship management experience.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is desired.
- Excellent organizational, written and verbal communication, commercial acumen.
- Experience in supply planning or inventory management.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Nationwide

Jazz Pharmaceuticals, Inc.

Senior Manager, Research Laboratory Operations

**If you are a current Jazz employee please apply via the Internal Career site.**

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit [www.jazzpharmaceuticals.com](<https://www.jazzpharmaceuticals.com>) for more information.

**Brief Description**

We are seeking a highly organized, collaborative, and motivated Senior Manager, Research Laboratory Operations to lead our research laboratory in Durham, NC, and actively participate as a hands-on scientific partner on key research projects. Reporting directly to the Chief Scientific Officer (CSO), Oncology, this dual-function role is pivotal in ensuring the smooth, safe, and compliant daily operation of our research facility while directly contributing scientific expertise to advance our pipeline.

The ideal candidate will seamlessly blend strong laboratory operations leadership with a solid background in drug discovery, specifically offering hands-on experience in screening methodologies, biochemical assays, and cell culture.

**Key Responsibilities**

1. Research Laboratory Operations & Management (approx. 60%)

- Laboratory Management: Oversee the daily operations of the Durham research lab, maintaining an efficient, highly organized, safe, and fully functional environment for the scientific team.
- Equipment & Inventory: Manage the procurement, maintenance, decontamination, calibration, and repair of all laboratory equipment (including biosafety cabinets, live cell imaging systems, liquid handlers, and other analytical instruments). Oversee inventory and supply chain for lab consumables, reagents, and specialized materials.
- Safety & Compliance: Ensure all laboratory activities comply with institutional, local, state, and federal safety regulations (including OSHA and biosafety guidelines). Oversee lab safety protocols, hazardous waste disposal, and general laboratory hygiene.
- Budget & Vendor Management: Manage laboratory spending, assist in tracking the operational budget, process purchase approvals, and coordinate with external vendors, contractors, and service providers.
- Cross-Functional Collaboration: Partner with facilities management, EH&S, procurement, and R&D project management to coordinate space planning, equipment utilization, and continuous operational improvements.

2. Scientific Project Contribution (approx. 40%)

- Assay Development & Execution: Support ongoing pipeline programs by conducting hands-on in vitro research, with a strong focus on screening platforms and biochemical assays.
- Experimental Support: Manage cell cultures of cancer and normal cell lines; execute mechanism of action, target validation, and biomarker studies for therapeutic candidates.
- Data & Documentation: Document and archive experimental protocols, raw data, analyses, and conclusions according to established laboratory procedures and electronic lab notebook (ELN) standards.
- Scientific Communication: Actively participate in the communication of research findings, presenting data in internal project team meetings, contributing to conference abstracts, and supporting the preparation of manuscripts for publication.

**Required Knowledge, Skills, and Abilities (Qualifications**)

- Education: MS or PhD (or equivalent practical experience) in Biology, Biochemistry, Oncology, or a related scientific discipline.
- Industry Experience: Proven track record of successfully managing a research laboratory within the pharmaceutical or biotechnology industry.
- Technical Skills: Hands-on experience running, troubleshooting, and supporting screening platforms and biochemical assays is highly preferred. Competency in mammalian cell culture and standard molecular biology techniques is required.
- Therapeutic Area: Previous background or experience in oncology research is preferred, but not required.
- Leadership & Organization: Exceptional organizational, communication, and problem-solving skills, with a positive, "hands-on" approach to the role. Demonstrated success working in a matrixed, cross-functional environment.

**Physical Demands & Work Environment**

- Requires the ability to perform routine laboratory work, stand or sit at a biosafety cabinet or lab bench for extended periods, and utilize computer systems.
- May occasionally lift objects up to 25 pounds.
- **This is a full-time, laboratory-based, on-site role in our Durham, NC facility.**

\#LI-SM1

\#LI-onsite

*Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.*

**FOR US BASED CANDIDATES ONLY**

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $136,000.00 - $204,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: [https://careers.jazzpharma.com/benefits.html](<https://careers.jazzpharma.com/benefits.html>).

North Carolina

IDEAYA Biosciences

Director, Commercial Supply Chain

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

We are seeking an experienced, strategic, resourceful and highly motivated Director, Commercial Supply Chain to lead end-to-end commercial supply planning and operational launch readiness for IDEAYA Biosciences’ first commercial product, Darovasertib, ensuring product availability, compliant distribution, and robust performance management.

This role requires an individual with demonstrated ability to operate effectively in a fast-paced and evolving environment, engage cross-functionally (Quality, CMC, Commercial, Regulatory, Accounting/Finance, IT), and communicate clearly and proactively across internal and external stakeholders. The ideal candidate will be a collaborative leader and critical thinker who can operate with autonomy, manage complex drug supply chains, and translate commercial demand forecasts into actionable supply strategies.

This position reports to the VP, Clinical and Commercial Supply Chain and is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Vice President, Clinical and Commercial Supply Chain

Job Description

**What you’ll do:**

- Own commercial supply strategy and launch readiness plans, ensuring supply chain readiness for launch and lifecycle supply.
- Develop and maintain integrated demand/supply plans, production schedules, capacity models, inventory strategy, and scenario analyses.
- Lead/drive S&OP cadence: monthly supply reviews, risk/opportunity assessments, mitigation actions, and executive-ready reporting.
- Lead end-to-end inventory management (GxP and SOX compliant) across the commercial supply chain, including inventory policy setting, reconciliation, cycle counting oversight, expiry tracking, and alignment with demand and production plans. System business owner for NetSuite Inventory Module.
- Manage external network execution; align campaign plans and batch execution to forecasts and contractual commitments.
- Partner with Finance/Accounting for reconciliations, chargebacks, rebates, etc.
- Oversee commercial packaging readiness: secondary packaging/labeling, serialization strategy/execution, artwork lifecycle coordination, shipping lane validation, cold-chain controls, and exception management.
- Serve as the primary point of contact for commercial packaging, labeling, logistics, and storage vendors and develop a governance process for effective management of these vendors.
- Build and monitor KPIs/dashboards (service level, plan adherence, capacity utilization, inventory health) and lead continuous improvement of planning tools/processes.
- Partner with Quality/Regulatory/CMC to ensure GxP-compliant release and distribution readiness and alignment to registration timelines.
- Support budgeting/forecasting for commercial supply activities, including scenario-based financial impact modeling.

**Requirements:**

- BA/BS in Supply Chain, Engineering, Life Sciences (advanced degree preferred).
- 10–12+ years in biotech/pharma supply chain, including 3+ years commercial and/or late-stage launch readiness experience.
- Experience serving as a California Board of Pharmacy–designated representative (DR) for manufacturer, wholesaler, or distributor licensing, or eligibility and willingness to serve in this role.
- Proven experience managing external manufacturing and supply partners.
- Strong understanding of GMP/ GDP, regulatory timing impacts on supply, and global distribution logistics.
- Advanced planning/analytics skills (Excel and/or supply planning tools); strong cross-functional leadership and communication.
- Comfortable operating in ambiguity; able to build processes “from the ground up”.

- The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment.
- Proficiency in Microsoft Office Suite and experience with collaborative platforms (e.g., SharePoint, Box) and NetSuite inventory systems.
- Willingness and ability to travel domestically and internationally as needed.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, Commercial Supply Chain is $203,000 - $251,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

Director, CMC Process Chemistry

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

We are seeking an experienced and highly motivated Director, Process Chemistry to join our multidisciplinary team based in South San Francisco. This role requires the candidate to work collaboratively with the related cross-functional teams to support our drug discovery pipeline. The successful candidate will be responsible for but not limited to those responsibilities listed below.

This position is based in our South San Francisco headquarter offices and is required to be onsite four days per week per our company policy.

Reporting to: Senior Director, Head of Process Chemistry

Job Description

**What you’ll do:**

- Lead Process Chemistry efforts in facilitating drug substance (DS) development by managing multiple CDMOs across all stages of drug development (pre-clinical, Phase I – III, and commercial). This position will be responsible for traditional small molecule targets and may also support the scale up of small molecule ADC payload/linkers.
- Author and review technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations.
- Author and review necessary technical sections in IND/IMPD/NDA documents supporting global CMC regulatory submissions and remain current on Health Authority guidance and expectations.
- Represent DS/CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of DS to support PK/PD, efficacy, DRF and pilot toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.
- Collaborate closely in cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Analytical Chemistry, Formulation, Toxicology, Quality, Project Management, CMC Regulatory, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Proactively communicate with and work closely with other functions to align DS and CMC strategies to achieve and maintain aggressive timelines to ensure goals are met.
- Lead the evaluation, selection, and management of CDMOs to perform DS development, and GMP manufacture.
- Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.

**Requirements:**

- Ph.D. in Chemistry with a minimum of 10 years (or a M.Sc. with a minimum of 14 years) of chemical process development experience in a pharmaceutical or biotechnology company, and demonstrated ability in leading cross-functional groups. Late phase and commercial experience are a plus.
- Track record of success in delivering timely execution of DS and CMC activities ranging from preclinical, IND-enabling and NDA material supplies and commercialization. Experience in the manufacture of small molecule ADC payload/linkers is desired.
- Strong understanding of Quality systems including SOPs, manufacturing batch record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
- Established knowledge and application of current industry standards and regulatory authority guidance and expectations, including ICH, FDA, and EMA guidelines.
- Experience managing global CDMOs, both dedicated FTE teams and FFS projects.
- Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed.
- Excellent interpersonal and communication skills for internal and external collaborations.
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic.
- Able to travel domestically and internationally to oversee DS development and manufacturing at CDMOs.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Director, CMC Process Chemistry is $206,000 - $254,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite in the office at the Company’s facilities for training & meetings, with work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

Associate Director, Clinical Supply Chain

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco, CA.

Position Summary:

IDEAYA is seeking an Associate Director of Clinical Supply Chain. The role of Associate Director is responsible for providing execution support for all aspects of clinical trial materials (CTM) for all clinical trials of IDEAYA programs. This position will provide support to the leadership of Clinical Supply Chain in the planning, forecasting, material sourcing, packaging and labeling, distribution, return and destruction of IDEAYA investigational drugs. The essential responsibilities of Associate Director include (but not limited to) clinical trial supply management, vendor management, oversight of external partners including depots and Contract packaging Organizations to ensure robust and compliant supply chain for all IDEAYA’s programs and in accordance with applicable laws and regulations. This role requires close coordination and collaboration with stakeholders across multiple functional areas within IDEAYA including CMC, QA, QC, Clin Dev/Clin Ops, Regulatory, and Program Management.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Director, Clinical Supply Chain

Job Description

What you’ll do:

Clinical Supply Management (General):

· Assist with identification and management of external global partners (e.g., depots, couriers, CMOs, IRT vendors) to ensure availability of drug supply at depots/clinical trial sites.

· Lead and assist with developing, maintaining, and implementing supply chain policies, procedures, systems and techniques with a focus on continuous improvements.

· As requested, assist with the preparation of the departmental budget, collaborate with Finance to address budget and invoice inquiries

· Create and/or revise study specific Pharmacy Manuals and supply related training/instructional materials (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.) based on protocol requirements.

· Ensure appropriate documentation of IP supply activities is filed for the Trial Master File

· Participate in relevant team meetings providing clinical supply status and support

· Manage supply planning/demand forecasting to ensure alignment with study activity and timelines

· Monitor inventory levels at clinical sites and depots throughout the life of a trial taking preventative actions to avoid potential supply issues; management may be manual or automated depending on study phase and complexity

· Establish and document a supply plan for each project as applicable.

· Assist with procurement and management of commercially sourced supplies

· Follow-up and resolve Temperature Excursions and/or Product Complaints from sites/depots

· Ensure expiry extensions are provided to depot/sites as needed to support continued use

· Collaborate with study team and vendors to assure proper distribution of clinical supplies to study sites

· Manage return and destruction of clinical supplies, with proper documentation of all steps.

· Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts provided by Clinical Operations

· Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice

· Support QA with timely review and approval of batch records for packaging and labeling of study drug

Vendor Management/Oversight

· Serve as point of contact for third party packaging, labeling, distribution, storage Vendors, and CRO for assigned projects representing Clinical Supply Chain

· Serve as the point of contact for study specific IRT URS, UAT and enhancements in support of clinical supply management

Packaging and Labeling

· Preparation of label text, coordination of label translations and proofs that align with county specific regulatory requirements

· Review of pre and post executed labeling batch records

· Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (e.g., QP Release, Certificates of Analysis/Compliance, Country specific CTM release)

· Coordinate expiry date extensions and re-labeling operations, when applicable

· Oversee maintenance of appropriate quantity of retain samples

IRT (Interactive Response Technology) Systems

· Work with cross-functional teams to develop study-specific IRT specifications and requirements from a Clinical Supply perspective

· Perform user acceptance testing (UAT)

· Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment

· Perform unblinded IRT functionality monitoring to assure resupply generation, etc. occur within defined specifications

· Post IRT deployment, manage system updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions, etc.

· Serve as the point of contact for supply related issues reported by clinical sites and managed within the IRT

Distribution

· Oversee and prepare documentation to support import/export of globally transferred CTM as needed

· Support movement of CTM from depots to clinical sites regionally from depots

· Provide site specific documentation as needed to depots and clinical sites to ensure on time and compliant delivery of CTM to clinical sites

Requirements:

· BA/BS in Supply Chain, Engineering, or life sciences; certifications such as APICS, CPIM, CIRM, PMP are desirable.

· 10+ years’ experience in biotech/Pharmaceutical industry with 7+ years’ experience in Supply Chain. Experience with CMC operations is desirable.

· Demonstrated ability to establish supply chain strategy from clinical protocol.

· Demonstrated knowledge of forecasting and inventory management, pooling supplies, drug product allocation, and IRT drug management modules

· Demonstrated experience in management of IRT systems

· Demonstrated experience in supporting global oncology trials with globally labelled CTM including packaging and over labeling commercial drug supply for combination trials

· Demonstrated skill in successful international shipment, including customs clearance

· Proven experience managing clinical drug supply for phase 1-3 global trials, Expanded Access Programs (EAP), and Investigator sponsored trials (IST)

· Proven experience working with and managing external packaging and distribution partners

· Demonstrated ability in working with cross functional teams including Clinical Operations, QA, CRO, CMC, Regulatory, and Program Management

· The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment

· Ability to think strategically to anticipate risk to supply chain and develop mitigation strategy

· Having deep understanding of GMP/GDP/GCP, impact of regulatory timing on supply chain, global distribution and logistics

· Proficiency in MS Office Suite and IRT. Experience with drug supply forecasting technology is strongly preferred.

Travel required: Yes

Percentage of time in a year: 5-10%

Domestic or International: Domestic

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Total Rewards

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the role of Associate Director, Clinical Supply Chain is $167,000 - $206,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

Medical Director, Drug Safety and Pharmacovigilance

**Non-Solicitation Policy and Notice to Agencies and Recruiters:**

**IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships**. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.

Location: South San Francisco

Position Summary:

We are seeking an experienced Medical Director of Patient Safety and Pharmacovigilance to join IDEAYA.

The Medical Director, Medical Safety – ICSR provides medical leadership and clinical oversight for Individual Case Safety Report (ICSR) activities across the company’s global pharmacovigilance program. This role is primarily responsible for high-quality medical review of safety cases and serves as the key medical interface with the company’s pharmacovigilance vendor for day-to-day case processing activities.

The role partners closely with Safety Operations, who shares responsibility for vendor oversight related to case processing, quality, and compliance. Together, they ensure timely, consistent, and inspection-ready safety reporting in a growing organization.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Senior Medical Director, Patient Safety & Pharmacovigilance

Job Description

**What you’ll do:**

- Serve as the primary medical expert who performs and oversees medical review of ICSRs, including complex, and medically significant cases in the oncology therapeutic area
- Provide clinical assessment of adverse events, including causality, seriousness, expectedness, and review narrative content for clinical accuracy and flow
- Act as the primary medical point of contact for the pharmacovigilance vendor for day-to-day ICSR-related questions and escalation

- Provide medical input into vendor oversight activities, including case quality review, accuracy of triage, and regulatory submission compliance
- Support development of medical review guidelines, training materials, and vendor-facing instructions

- Collaborate closely with the IDEAYA Safety Operations team to ensure quality across global case processing activities by monitoring quality metrics and address non-compliance events
- Conduct and oversee thorough investigations of quality events, deviations and CAPAs pertaining to case processing and regulatory compliance
- Support development, implementation and tracking of CAPAs

- Participate in vendor governance meetings as the medical representative

- Support regulatory inspections, audits, and health authority inquiries related to ICSR processing and medical review
- Contribute to the development and maintenance of SOPs and work instructions related to medical case review
- Serve as the medical safety point of contact for any assigned molecule(s)
- Provide safety input for aggregate safety reports, protocol amendments, investigator’s brochure, informed consent and other key regulatory safety documents.
- Partner with Safety Science, Regulatory Affairs, and Clinical teams as needed on safety issues requiring medical input

**Requirements:**

- MD (or equivalent international medical degree) with 2+ years of bedside clinical experience
- 5–8+ years of oncology experience in drug safety/pharmacovigilance
- Strong hands-on ICSR medical review experience
- Demonstrated experience working with external PV vendors or CROs
- Solid knowledge of global PV regulations (FDA, EMA, ICH)
- Strong medical judgment, attention to detail, and ability to work effectively in a matrix environment

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

**Total Rewards**

Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Medical Director, Drug Safety and Pharmacovigilance is $268,000 - $331,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at hr@ideayabio.com.

AbbVie

Technician, Pilot Plant IV ( 2nd shift)

Company Description

**About AbbVie**

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](<http://www.abbvie.com/>). Follow @abbvie on [LinkedIn,](<https://www.linkedin.com/company/abbvie/>) [Facebook](<https://www.facebook.com/AbbVieGlobal/>), [Instagram](<https://www.instagram.com/abbvie/>), [X](<https://twitter.com/abbvie>) and [YouTube.](<https://www.youtube.com/user/AbbVie>)

Job Description

Set-up, clean, and maintain equipment. Run process with supervision and consults appropriate personnel when confronted with a problem or when made aware of a situation. Observes quality characteristics of products and processes. Complete documentation per current good manufacturing practice guidelines and policies.

Responsibilities

- Learn and follow department policies, procedures and guidelines. Complete documentation and supporting data per cGMP policies, procedures, and guidelines.
- Maintain a safe and clean work environment.
- Develop systematic work habits that show effective organizational skills.
- Be able to prepare for process requirements following supervisory instruction.
- Note quality issues and address with appropriate people.
- Review procedures and batch records, and make suggestions for improvements. During pre runs, post runs and when reviewing direction sets identify safety issues and help to correct them.
- Consistently give an accurate and complete material and equipment status report when handing off manufacturing process.
- Learn and be able to use inventory system.

Qualifications

- High School diploma or GED equivalent required. Bachelors or Associates Degree in a scientific related field is desirable.
- Job requires basic technical or mechanical background and knowledge.
- Must have ability to:
  1. Read, understand, and follow verbal and written operating instructions and the processes and flows described on equipment/computer monitors;
  2. Write at a level sufficient enough to explain deviations or mistakes in process;
  3. Add, subtract, divide, multiply, use decimals and fractions, recognize and measure proportions, and do basic algebraic math at an intermediate level of competency.
- Knowledge and use of various tools, machines, instruments, and safety devices utilized in chemical or pharmaceutical operations is desired. The candidate should display mechanical aptitude and be able to follow written and verbal directions.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit [https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html](<https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html>)

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

[https://www.abbvie.com/join-us/reasonable-accommodations.html](<https://www.abbvie.com/join-us/reasonable-accommodations.html>)

Illinois

Eli Lilly and Company

Instrument Technician - Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Instrument Technician role is responsible for providing process instrumentation maintenance support for the Medicine Foundry. This position will focus on equipment availability, calibration, troubleshooting, and reliability while ensuring that the company’s assets are managed in compliance with cGMP and other applicable standards. In addition, this role ensures that necessary maintenance programs are followed including safety, quality, and efficiency, directly supporting the delivery of novel medicines for clinical trials within the Medicine Foundry. This position will be responsible for supporting initial equipment calibrations as well as long-term instrument reliability.

**Responsibilities**

In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

Safety –

- Comply with all HSE aspects including safety procedures, policies, permits, and practices.
- Knowledgeable and experienced in LOTO processes and procedures. Report all safety concerns, incidents, and injuries to supervisor.

Quality –

- Responsible meeting the quality standards as defined by cGMPs, the Global Quality Standards, and local procedures.

Calibration & Instrumentation Excellence –

- Demonstrate a good process aptitude and application of skills in a variety of real-world process experiences.
- Perform preventative and corrective maintenance on process instrumentation (pressure, temperature, flow, pH, conductivity, level, etc.).
- Effectively troubleshoot and diagnose process instrumentation equipment and make appropriate repairs to minimize downtime.
- Operate electrical, pneumatic, and temperature test equipment (flukes, signal generators, oscilloscopes, etc.).
- Provide process instrumentation support for the IQ/OQ parts of new equipment installations or modifications.
- Demonstrate the ability to read P&ID drawings and schematics.
- Provide accurate, complete, and legible work order documentation in GMARS.

**Basic Requirements:**

- High School Diploma or equivalent
- 5+ years of industrial process instrumentation and calibration experience in FDA regulated industry required.
- Strong understanding and troubleshooting skills in electrical systems and calibration, including the following:
  - Instrumentation (pressure, temperature, flow, level, pH, and conductivity)
  - Electrical test equipment (flukes, signal generators, oscilloscopes, etc.)
  - Electrical troubleshooting (24 VDC to 120 VAC)
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Ability to perform work without close supervision.
- Ability to work in a team environment.
- Demonstrated ability to provide high-level customer service.
- Demonstrated ability in problem solving process instrumentation equipment.
- Computer proficiency including Microsoft Office tools.
- Proficiency in CMMS (GMARS).

**Other Information:**

- Temporary location in Carmel, Indiana.
- Training and development location at Lilly Technology Center, Indianapolis and Lebanon, Indiana.
- Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
- Position will be working on a 2-2-3 shift either dayshift or nightshift.
- Must be willing to work overtime during peak periods (specifically during initial calibrations) to support business needs.
- Individual must be able to comply with all building gowning and necessary PPE requirements.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Indiana

Reliability Engineering Technician - Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization and Position Overview**

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

As a Reliability Engineering Technician, you will play a critical role in ensuring equipment availability and optimal performance across the site, supporting the delivery of novel medicines for clinical trials. Reporting to the Senior Reliability Manager, you will execute predictive maintenance programs, analyze equipment health data, and drive continuous improvement in maintenance strategies, all in compliance with cGMP and applicable regulatory standards.

**Responsibilities**

In line with the job outlined above, the following are typically the key tasks that would be expected of the role:

- Execute predictive maintenance (PdM) routes, including but not limited to, vibration analysis, ultrasound, thermal imaging, and oil sampling
- Execute precision lubrication activities across manufacturing and utility assets, including lubricant application, re-greasing, and oil top-offs in compliance with OEM specifications and site lubrication standards to extend asset life and reduce unplanned downtime
- Apply precision maintenance techniques, including laser shaft alignment, belt and sheave alignment, torque and tolerance verification in accordance with OEM specifications and site procedures, documenting all findings and completed work in GMARS
- Analyze equipment condition data to identify anomalies, degradation trends, and failure precursors; escalate findings with recommended corrective actions
- Support root cause failure analysis (RCFA) for critical and recurring equipment failures; track corrective actions to closure in GMARS
- Review and optimize preventive maintenance job plans, frequencies, and task content based on performance data and reliability analysis
- Maintain accurate records of all PdM activities, findings, and work orders in GMARS, including asset data, failure codes, and labor hours
- Communicate equipment health status to maintenance, engineering, and operations teams; coordinate reliability-driven work across functions
- Produce clear reports summarizing PdM program performance and overall equipment health
- Provide field troubleshooting support as needed, including outside normal business hours

**Required Qualifications**

- High School Diploma or equivalent and have 2 years experience in the trade or equivalent, or Technical Vocational College associate degree
- Hands‑on experience with condition monitoring technologies (Vibration, thermography and ultrasound)
- Experience with precision maintenance practices
- Working knowledge of rotating equipment, utilities, and manufacturing assets
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and the ability to learn and navigate site-specific software systems, including CMMS platforms and data analysis tools
- Possess knowledge of CMMS functionalities, workflows, and utilization
- Strong analytical skills with the ability to identify trends and communicate technical findings clearly
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Preferences:**

- Teamwork and interpersonal skills
- Communication across functional areas
- Computer Skills (Business Applications)
- Level 2 Vibration Analysis
- Level 1 Oil Analysis
- Level 1 Thermography
- Level 1 Ultrasonic
- Familiarized with RCM methodologies and applications
- SMRP Certification (CMRP and/or CMRT)
- Familiarity with mechanical, electrical, and instrumentation systems typical for a chemical manufacturing plant

**Additional Information**

- Role is permanently based at the Lilly Medicine Foundry in Lebanon, Indiana
- Supports a 24/7 operation; flexibility for off-hours support is required
- PPE is required when working in manufacturing areas

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$33.89 - $49.71

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Industrial Electrician- Medium Voltage, Instrumentation & Utilites

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Organization Overview:**

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

**Position Brand Description:**

The Industrial Electrician has the responsibility of servicing, troubleshooting, and maintaining equipment within the Lilly Technology Center manufacturing site that includes instrumentation, electrical, high purity water, compressed air, steam, chilled water, glycol, city water, and sewers. Responsible for ensuring safe, reliable, and efficient operations across all utility locations, while collaborating with and supporting multiple maintenance crafts to meet operational and maintenance objectives.

**Key Objectives/Deliverables:**

- Perform preventative and corrective maintenance on medium voltage electrical equipment (13.8KV main switch gear, circuit breakers, relays, motor starters, ground fault interrupts).
- Perform preventative maintenance on complex electrical equipment (motor control centers, variable-speed drives, programmable logic controllers, etc.).
- Troubleshoot and diagnose electrical equipment problems and make appropriate repairs to minimize downtime.
- Perform modifications and new installations of electrical equipment (e.g., conduit, conductors, lighting, branch circuits, etc.).
- Diagnose complex electrical problems to effect repairs and restore equipment/systems to operating condition.
- Perform preventative/corrective maintenance and calibration, modifications and new installations on process instrumentation (temperature, pressure, flow, pH, conductivity, TOC, control valves, etc.)
- Demonstrate the ability to read P&ID drawings.
- Consistently comply with safety rules and closely follow approved procedures to ensure cGMP compliance.
- Document all work by following Good Documentation Practices.

**Basic Requirements:**

- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
- Experience maintaining equipment in an industrial utilities environment. Familiarity with any of the following is an advantage: high purity water, compressed air, steam, chilled water, glycol.
- Candidates must hold a valid driver’s license.
- Willingness to respond to call-ins and work scheduled overtime is necessary.
- Ability to lift up to 40 pounds is required.
- Must be able to tolerate exposure to varying temperatures while performing duties outdoors in all weather conditions.
- A minimum of three years of relevant work experience is mandatory.

**Additional Skills/Preferences:**

- Associate's degree, Technical Certificate in an electrical discipline, or equivalent industrial electrical experience; military electrical training accepted. Experience with medium-voltage electrical systems (4.16kV preferred).
- Experience performing and troubleshooting electrical maintenance equipment in a manufacturing, industrial, or production environment.
- Ability to read, interpret, and work from electrical schematics, prints, and technical documentation.
- Knowledge of safe maintenance practices, work procedures, and documentation requirements.
- Proficiency using CMMS software (e.g., Maximo) for work order management and maintenance tracking. Microsoft Applications Knowledge (Word, Excel, Outlook, PowerPoint).
- Strong communication skills and ability to work effectively in a team environment.
- Experience collaborating with multiple skilled trades and supporting cross-functional maintenance activities.

**Education Requirements:**

- High school diploma or equivalent

**Additional Information:**

- This position is scheduled for 8 hours per day, Monday through Friday.
- Temporary shift changes may occur.
- Hazardous operations within Utilities include exposure to acid, steam, caustic substances, high pressure, and high temperatures.
- Personal protective equipment is required at all times.
- Work involves awkward positions, cramped quarters, ladders, and scaffolding.
- Employment requires working during summer and year-end company breaks.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.27 - $41.25

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Utilities Senior Operator (Night Shift) - Lilly Medicine Foundry

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Utilities Senior Operator is a self-directed team member who demonstrates a solid working knowledge of utility systems operations and equipment maintenance at the Lilly Medicine Foundry site, including high purity water, compressed air, steam, chilled water, heated water, chilled glycol, heated glycol, domestic water, cooling towers, tepid water, waste streams, VOC management, nitrogen systems, aqueous waste neutralization, and tank farm management (solvent tank filling and hazardous waste tank emptying).

This position requires minimal oversight and is expected to independently manage daily operational responsibilities, proactively address housekeeping and safety concerns, and support the development of Operators. The Senior Operator understands all utility processes at a working level and contributes to continuous improvement and safety initiatives. This position is designated for a permanent night shift assignment and operates on a fixed 12-hour 3-2-2-3 schedule (5:00 PM to 5:30 AM). During onboarding and site startup activities, team members may initially work a temporary day shift schedule before transitioning to nights in 2027.

**Responsibilities**:

- Independently operate, monitor, and maintain all assigned utility systems with minimal oversight, applying a solid working knowledge of equipment and processes.
- Proactively maintain housekeeping standards across utility operations areas and take initiative to address cleanliness issues without being directed.
- Identify and troubleshoot equipment and process issues, communicating findings and actions taken to supervisory personnel while resolving problems.

- Support the training and development of Operators by sharing knowledge, demonstrating correct procedures, and reinforcing safe work practices.

- Recommends continuous improvement ideas and identify safety concerns, elevating observations to the Expert Operator or Lead Operator for follow-up.

- Follow all SOPs, GMP requirements, and site EH&S protocols, and maintain accurate logs and documentation in accordance with Good Documentation Practices.

**Basic Qualifications:**

- High school diploma or equivalent required.
- Minimum of 5 years of experience in utilities, industrial, or mechanical operations required; experience in a GMP pharmaceutical manufacturing environment preferred.
- Must have mechanical aptitude.
- Must possess a valid driver’s license.
- Must be willing to respond to call-in and scheduled overtime work.
- Must be capable of lifting up to 40 pounds.
- Must be able to withstand exposure to temperature variations while performing work outside in winter and summer weather conditions.
- Must be able to wear respiratory equipment and work at elevated heights as needed.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

**Additional Skills/ Preferences:**

- Demonstrated ability to operate utilities systems including pumps, heat exchangers, chillers, compressed air, or water treatment equipment with minimal direction.
- Experience identifying and troubleshooting common equipment and process issues in an industrial or manufacturing environment.
- Proficient in data entry, log keeping, and documentation practices consistent with GMP and regulatory requirements.
- Prior experience supporting or participating in the training of less experienced team members.
- Familiarity with work order systems, CMMS platforms, or maintenance documentation tools.
- Demonstrated commitment to safety, housekeeping, and continuous improvement in a regulated manufacturing environment.

**Additional Information:**

- Initial location is Carmel, Indiana. Permanent location will be at the new Lilly Medicine Foundry in Lebanon, Indiana. Potential for short-term assignment at our sister plant (LP2) in Lebanon, IN for training and support.
- This position is located at Lebanon, IN - Lilly Medicine Foundry. Hazardous operations exist within Utilities, involving exposure to systems using acid, steam, caustic, high pressure, and high temperatures. Personal protective equipment is required. Awkward positions, cramped quarters, ladder, and scaffolding work will be required at times.
- Position Location: **Lebanon, IN - Lilly Medicine Foundry**
- Travel Percentage (%): **Minimal – less than 10%**
- **Shift Information**: This position is designated for a permanent night shift assignment and operates on a fixed 12-hour 3-2-2-3 schedule (5:00 PM to 5:30 AM). During onboarding and site startup activities, team members may initially work a temporary day shift schedule before transitioning to nights in 2027.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$21.63 - $42.31

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Group Leader, Environmental Risk Assessor

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

**Purpose:**

The Environmental Risk Assessment group provides enterprise leadership for environmental risk assessments (ERAs) that support global regulatory submissions, environmental stewardship commitments, and strategic management of issues related to pharmaceuticals in the environment (PiE). Positioned within Lilly’s research and development organization, the group applies scientific judgment to design fit-for-purpose testing strategies for portfolio assets and to anticipate evolving regulatory expectations.

**Primary Responsibilities:**

This scientific role leads the ERA Group and is accountable for the strategy, quality, and timely delivery of environmental studies and risk assessments that characterize the interaction of Lilly therapeutics with the environment. The group leader serves as a people leader, scientific leader, strategic consultant, and technical expert for PiE-related issues across Lilly’s portfolio, manufacturing network, regulatory functions, and external engagement forums.

**Key Objectives:**

Lead the ERA Group by setting scientific direction, developing environmental scientists, and building environmental risk assessment capability across the portfolio.

Own portfolio ERA testing, prioritization, study governance, and submission-ready delivery for global regulatory registrations.

Direct execution of environmental studies that meet regulatory expectations through fit-for-purpose CRO partnerships that ensure GLP compliance, data quality, and reliable report delivery.

Advance Lilly’s diverse portfolio and ERA science by identifying and fostering innovative solutions and cross-functional collaboration.

Communicate ERA strategy, risks, decisions, and regulatory implications to Lilly leadership, project teams, and regulatory functions.

Advise manufacturing on pharmaceutical discharge limits and implementation strategies that protect people, ecosystems, and business continuity.

Lead PiE governance by assessing internal and external developments, framing business implications, and driving mitigation strategies through cross-functional partnership with GHSE, Governmental Affairs, R&D.

Represent Lilly externally to benchmark guidelines, influence regulatory expectations, shape industry positions, and guide external research engagement.

**Minimum Qualification Requirements:**

- PhD in environmental or natural sciences, or related field
- 15 years experience in chemical environmental risk assessment in pharmaceutical or pesticide industry and/or as consultant to such industries
- Research experience in environmental toxicology and/or environmental fate
- Experience with OECD environmental studies and GLPs
- Confirmed skills in scientific communication via published papers and presentations

**Other Information/Additional Preferences:**

- Demonstrated effective cross functional and external influencing skills
- Strong analytical and critical thinking skills and an ability to interpret data from environmental studiesAbility to organize and lead task teams to consensus deliverable
- Strong understanding of the scientific method
- Broad understanding of global environmental policies/issues and potential business implications especially those that impact pharmaceutical environmental risk assessment
- Familiarity with pharmaceutical or pesticide risk assessment processes
- Previous Pharma or Industry experience

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ([https://careers.lilly.com/us/en/workplace-accommodation](<https://careers.lilly.com/us/en/workplace-accommodation>)) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$148,500 - $257,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

\#WeAreLilly

Terray Therapeutics

Technician, Purification

**Company Overview:**  Terray Therapeutics is a venture-backed biotechnology company where scientists and engineers build together to transform how small-molecule drugs are discovered and developed. By combining our nanotechnology, experimental science, machine learning, and automation, we leverage Terray’s ability to generate and learn from scale proprietary chemical data to discover novel medicines for patients in need.

At Terray, you will work alongside pioneers and experts in artificial intelligence, chemistry, drug discovery, automation, and nanotechnology in deeply interconnected workflows where computational and experimental teams continuously learn from one another. Our platform, EMMI (Experimentation Meets Machine Intelligence), powers iterative cycles of molecular design and wet-lab experimentation that rapidly improve our understanding of biochemical interactions and guide the next generation of discoveries.

Our teams support both an internal immunology pipeline and partnerships across a broad range of therapeutic areas. The work here is highly collaborative, fast-moving, and grounded in the belief that breakthroughs happen when strong science, thoughtful technology, and great people work closely together.

**Position Summary:** We are seeking a detail-oriented Technician to join our Analytical and Purification group. In this role you will support synthetic chemistry programs by identifying, purifying, and characterizing small-molecule compounds using chromatographic and mass spectrometry techniques. You will help operate an open-access / walk-up purification service, deliver high-purity compounds and analytical data back to requestors, and maintain the instrumentation and workflows that keep the discovery pipeline moving.

Technical operations (80%) – Part of analytical and purification chemistry efforts involving instrument operation and maintenance, sample handling and tracking, and delivering on upstream requestor demands on fast and flexible timelines.

Continuous Improvement/Ad-Hoc Projects (20%) – R&D efforts to improve internal capabilities as opportunities and business needs dictates and arises.

The core responsibilities of this position are:

- Develop and optimize analytical and preparative methods to assess and purify compounds on LC/SFC-MS platforms for the separation, identification, and isolation of compounds submitted by client chemists using reversed-phase and normal-phase prep-HPLC, mass-directed prep-HPLC, and flash chromatography.
- Run high-throughput analysis and characterization of crude reaction mixtures and purified compounds, confirming identity and purity by UPLC/HPLC-UV, LC-MS, and (as needed) NMR.
- Support a walk-up / open-access LC-MS and purification service, assessing incoming samples and returning purified material and data with quick turnaround.
- Accurately track sample identity, recovery, and yield through analytical and purification workflows.
- Perform routine preventive maintenance, calibration, and troubleshooting of analytical and preparative instrumentation and associated software, escalating and coordinating service with vendors as needed.
- Maintain accurate, current, and well-organized records of all work either on paper or digitally in accordance with laboratory data integrity and safety standards.
- Follow all safe laboratory practices and contribute to a clean, well-run shared instrument environment including following all SOP, safety procedures and training, and proper waste management and disposal.

Assuming the completion of laboratory technical operations as listed above as priority above all other tasks, additional opportunities may include:

- Directly assist in, or provide constructive feedback to improve workflow efficiency, throughput, and chemistry performance, and help implement best practices.
- Engage in cross-team projects and deliverables.

**Experience and Qualifications:** Part of Terray's success is nurtured by a hands-on work environment where everyone is accountable, vested in a vision of excellence, and actively taking part in the success of the business. Terray supports a positive work environment where employees can feel engaged, recognized, and empowered to be creative.

*Required Qualifications:*

- B.S. in Chemistry, Analytical Chemistry, Organic Chemistry, Biochemistry, or a related discipline.
- Hands-on experience with analytical and preparative scale chromatography — HPLC/UPLC and prep-HPLC
- Working knowledge of chromatographic principles such as reverse and normal phase chromatography, mobile/stationary phase selection, and related chemical knowledge
- Very strong attention to detail, sample tracking discipline, and data integrity habits.
- Ability to manage a high sample throughput and competing priorities in a high-throughput, deadline-driven environment.
- Strong written and verbal communication skills; works effectively both independently and as part of a collaborative, cross-functional team.

*Preferred Qualifications:*

- B.S. with 1–3+ years of relevant industry experience preferred for this level, or M.S. with 0+ years of experience.
- Ability to operate and troubleshoot chromatography and MS hardware and software (e.g., Agilent 1100/1200/1260/1290 series with ChemStation/OpenLab, Waters systems with MassLynx/FractionLynx, ThermoFisher XCalibur/Chromeleon, or comparable).
- Experience with mass spectrometry/gas phase chemistry and other hyphenated techniques (LC-MS, GC-MS, MS-MS) for compound identification.
- Knowledge of small molecule and general synthetic chemistry.
- Experience with MS-directed / mass-triggered preparative purification and automated open-access purification platforms.
- NMR interpretation for structure confirmation and purity assessment.
- Experience supporting medicinal chemistry or small-molecule drug discovery programs in a pharma or CRO setting.
- Familiarity with instrument automation, electronic lab notebooks, and chromatography data systems.

*Work Environment & Physical Requirements:*

- Laboratory-based role requiring routine work with solvents and reagents under appropriate engineering controls and PPE.
- Ability to stand for extended periods and lift laboratory items (typically up to ~40 lbs, e.g., solvent containers, plastic consumables).

**Schedule:**  The person hired in this role will complete a 30-day training period with the existing Terray Purification team on a Monday-Friday 9AM-5PM schedule before switching over to a permanent Saturday to Wednesday or Wednesday to Saturday 4-day, 10-hour schedule, depending on the employee's choice prior to training.

**Compensation Details:**  $70,500–$78,000 annually, depending on experience. Terray’s salary ranges are designed to be competitive and are benchmarked against market base salary plus bonus within our industry and market. We align pay to role scope, skill level, and impact.

We invest heavily in benefits because taking care of our people matters. Our programs are benchmarked at the top of the Southern California market and designed to provide meaningful support across every stage of life. Benefits include participation in the Company’s stock option plan, a 3% retirement safe harbor contribution, fully paid health, dental, vision insurance for our employees, spouse, partner and families as well as above-market life insurance, disability coverage, and much more to explore during the offer process.

Syner-G BioPharma Group

Regional Director, Southeast

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

We are seeking a dynamic and motivated Regional Director of Technical Operations, Southeast to lead our operations and growth strategy in the Raleigh-Durham area, with accountability for performance and client satisfaction across a diverse portfolio of technical projects. This role is responsible for developing and executing the regional account strategy, building and leading teams, and fostering a culture of delivery excellence.

**WORK LOCATION**:

Travel to client sites may be required based on project demands and client expectations.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented or changed as necessary.)

*Account Management and Delivery:*

- Leads a high-performing engineering organization responsible for the successful operational delivery of projects across the regional portfolio of client projects.

- Acts as a true partner in meeting the needs of clients’ business. Must listen, be passionate about exploring opportunities, and solve client problems proactively on an ongoing basis.

- With partners in Commercial, develop and executes the regional account strategy, including proactive client retention and expansion as well as identifying and supporting development of new business.

- Engages in active participation in the RTP life sciences community with an established network of professional relationships. Drives visibility through industry events, social media, and other marketing initiatives and engagement opportunities.

*Business Acumen and Collaboration:*

- Builds productive relationships with Commercial, Marketing, and other functions (HR, Finance, Talent Acquisition) to support delivery of services to the customer and minimize risk to the business.

- Partners with other service delivery groups to identify and pursue cross-sell opportunities outside of Technical Operations.

- Develops annual operating budgets and periodic forecasts, manages regional P&L to meet regional and company goals.

*Leadership:*

- Builds, develops, and mentors a high-performing engineering organization focused on technical competence and proactive service to the client.

- Works to elevate the way our teams think and operate, creating a culture that results in an engaged workforce.

- Creates an environment of inclusion and recognition that emphasizes development and reinforces the commitment to our people as our most important asset.

**QUALIFICATIONS AND REQUIREMENTS:**

*Education*:

- Bachelor’s degree in Engineering, Operations, or related field or equivalent experience with strong business and financial aptitude; MBA desirable

*Experience*:

- 10-15 years of overall life sciences industry experience.

- 5-10 of experience in project delivery, engineering operations or technical program management.

- 5 or more years of leadership in GMP manufacturing facility design, construction, startup, engineering, and/or operations.

- Demonstrated business development success, with the ability to sell services and expand client relationships in a competitive environment.

- Strong experience in one or more of the following areas: Capital Projects, Facilities Engineering, Process, Automation, CQV, and/or Project Management.

- Ability to build, develop, and motivate high-performing teams to support and deliver multiple projects under demanding timelines.

- Proven track record of project delivery for laboratory and/or manufacturing facilities and operations in regulated industries such as biotech, pharmaceuticals, or advanced therapeutics.

- Exceptional customer relationships and client management skills.

- Excellent communication, leadership, and organizational skills.

*Preferred Qualifications:*

- Prior experience working as a consultant or managing a portfolio of client projects.

**ESSENTIAL FUNCTIONS**:

*Physical Demands:*

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment:*

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

Project Manager

**COMPANY DESCRIPTION:**

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video [**here**](<https://www.youtube.com/watch?v=2rUMvtncuw8>).

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit [www.Synergbiopharma.com](<https://www.synergbiopharma.com/>)

**POSITION OVERVIEW:**

The Project Manager is responsible for guiding clients through the development, installation, and execution of comprehensive Operational and Business Excellence programs. This role leads the delivery of a continuous improvement and organizational change framework that enables clients to adopt a common language, processes, tools, and systems that drive sustainable transformation.

**KEY RESPONSIBILITIES:**

(This list is not exhaustive and may be supplemented and changed as necessary.)

- Lead, deploy, and strengthen client capabilities to establish holistic Business and Operational Excellence programs.
- Serve as a strategic partner to client leadership, contributing to organizational goals, transformation roadmaps, and long‑term strategy execution.
- Translate strategic objectives into actionable operational goals and structured improvement initiatives.
- Support the definition and evolution of organizational structures, roles, and governance models that enable Operational Excellence and change adoption.
- Provide leadership in shaping, communicating, and reinforcing a strategic vision for Business Excellence across client organizations.
- Develop and manage transformation roadmaps in partnership with cross‑functional client teams, ensuring alignment, prioritization, and measurable outcomes.
- Coach leaders and teams on structured problem‑solving methodologies (Lean, Six Sigma, etc.) and change management practices.
- Collaborate with internal and external stakeholders to ensure alignment with program strategies, change impacts, and organizational readiness.
- Track and influence key success measures including team engagement, Operational Excellence maturity, Lean Six Sigma capability development, and measurable improvements in quality, cost, and delivery.
- Apply business excellence methodologies across diverse environments including operations, labs, engineering, administrative functions, and other business processes.
- Support organizational change management activities such as stakeholder engagement, communication planning, readiness assessments, and adoption tracking.
- Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

**QUALIFICATIONS AND REQUIREMENTS:**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

*Education:*

- Bachelor’s or Master’s degree (preferred) in a related technical and/or business discipline or equivalent experience.

*Technical Experience:*

- Minimum of 9–15 years of demonstrated leadership in the medical device industry or a directly related field.
- Certified Lean Six Sigma Black Belt or equivalent, with extensive project experience applying LSS methodologies.
- Strong background in holistic operational excellence frameworks, continuous improvement systems, and associated tools/techniques.
- Experience leading organizational change initiatives, including communication, stakeholder management, and adoption planning.

*Knowledge, Skills, and Abilities:*

- Comfortable guiding teams and leaders at all levels through operational excellence and organizational change.
- Dynamic and engaging facilitation and training skills.
- Strong coaching and mentoring capability, particularly in problem‑solving and change leadership.
- Ability to simplify and communicate complex concepts clearly and effectively.
- Self‑starter who works independently, maintains a positive attitude, and drives momentum. Knowledge of and compliance with applicable Quality System requirements.
- Ability to thrive in a fast‑paced environment while managing multiple priorities.
- Flexible, adaptable, and able to operate both independently and collaboratively.

**ESSENTIAL FUNCTIONS:**

*Physical Demands:*

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

*Work Environment:*

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

**TOTAL REWARDS PROGRAM:**

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

**COMPENSATION:**

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $170,000 yearly in our lowest geographic market up to $180,000 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience.

Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time.

**LEGAL STATEMENT:**

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.