Engineering

Insmed Incorporated

Director, Process Chemistry

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Director, Process Chemistry on the API Development team to help us expand what’s possible for patients with serious diseases. You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including synthesis route and early-stage process identification, tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.

**What You'll Do:**

In this role, you’ll have the opportunity to manage API/Intermediate/RSM manufacturing at Insmed’s CMOs. You’ll also:

- Act as the Technical Operations collaborator with the Insmed research team for lead optimization and early development programs

- Drive the dynamic cross‑functional interaction between lead optimization research and early CMC development via a discovery process chemistry (DPC) philosophy

- Manage oversight of tech transfer, scale-up, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process

- Provide technical support as Insmed’s internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of any process improvement related projects

**Who You Are:**

You have a PhD along with 5+ years of experience managing development and execution of API manufacturing processes

You are or you also have:

- 5+ years of experience leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment

- Experience managing CMO operations

- Experience in NCE including total synthesis, physical organic chemistry

- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals

- Experience with providing technical authoring of CMC drug substance sections of regulatory filings and dossiers

- Sound awareness of Regulatory, Quality Assurance, and cGMP requirements

- High energy, innovative “can do” attitude

- Strong interpersonal skills and the ability to work in a fast‑paced, multidisciplinary environment. Strong verbal and written communication skills

**Nice to have (but not required):**

- PhD in Organic Chemistry (Organic Synthesis) or Chemical Engineering (Crystallization/Solid State expertise)

- 10+ years of experience managing development and execution of API manufacturing processes of products marketed in the US, EU, JP for entire development to launch lifecycle

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This role requires occasional domestic/international travel (approximately 10%)

\#LI-Remote

\#LI-DM1

**Pay Range:**

$177,000.00-242,000.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Nationwide

Senior Manager, Process Chemistry

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for a Senior Manager, Process Chemistry on the API Development team to help us expand what’s possible for patients with serious diseases. You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.

**What You'll Do:**

In this role, you’ll have the opportunity to manage API/Intermediate/RSM manufacturing at Insmed’s CMOs. You’ll also:

- Manage oversight of tech transfer, scale-up, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process

- Provide technical support as Insmed’s internal SME, technical review of quality documentation, and management of any process improvement related proj

**Who You Are:**

You have a PhD

OR

You have a Master’s along with 3+ years of experience managing development and execution of API manufacturing processes

You are or you also have:

- 2+ years of experience contributing to teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment

- Experience collaborating with CMO operations

- Experience in NCE including total synthesis, physical organic chemistry

- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals

- Working knowledge of CMC drug substance sections of regulatory filings and dossiers

- Sound awareness of Regulatory, Quality Assurance, and cGMP requirements

- High energy, innovative “can do” attitude

- Periodic technical support to commercial product portfolio

- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment

- Strong verbal and written communication skills are essential

**Nice to have (but not required):**

- Master’s or PhD in Organic Chemistry (synthesis) or Chemical Engineering (crystallization)

- 4+ years of experience in development and execution of API manufacturing processes (preferably of products marketed in the US, EU, JP)

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This role requires occasional domestic/international travel (approximately 10%)

\#LI-Remote

\#LI-DM1

**Pay Range:**

$127,000.00-165,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

Associate Director, Process Chemistry

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as *Science* magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on *The Sunday Times* Best Places to Work list in the UK.

For patients, for each other, and for the future of science, we’re in. Are you?

**About the Role:**

We’re looking for an Associate Director, Process Chemistry on the API Development team to help us expand what’s possible for patients with serious diseases. You’ll have responsibility for the management of API/Intermediate/RSM manufacturing at Insmed’s CMOs including synthesis route and early-stage process identification, tech transfer, process optimization, clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy.

**What You'll Do:**

In this role, you’ll have the opportunity to manage API/Intermediate/RSM manufacturing at Insmed’s CMOs. You’ll also:

- Act as the Technical Operations collaborator with the Insmed research team for lead optimization and early development programs

- Drive the dynamic cross‑functional interaction between lead optimization research and early CMC development via a discovery process chemistry (DPC) philosophy

- Manage oversight of tech transfer, scale-up, process optimization, clinical/commercial manufacturing and ensuring the continued refinement and enhancements of the manufacturing process

- Provide technical support as Insmed’s internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of any process improvement related projects

**Who You Are:**

You have a PhD along with 2+ years of experience managing development and execution of API manufacturing processes

OR

You have a Master’s along with 6+ years of experience managing development and execution of API manufacturing processes

You are or you also have:

- 5+ years of experience leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment

- Experience managing CMO operations

- Experience in NCE including total synthesis, physical organic chemistry

- Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals

- Experience with providing technical authoring of CMC drug substance sections of regulatory filings and dossiers

- Sound awareness of Regulatory, Quality Assurance, and cGMP requirements

- High energy, innovative “can do” attitude

- Strong interpersonal skills and the ability to work in a fast‑paced, multidisciplinary environment

- Strong verbal and written communication skills

**Nice to have (but not required):**

- PhD in Organic Chemistry (synthesis) or Chemical Engineering (crystallization)

- 10+ years of experience managing development and execution of API manufacturing processes of products marketed in the US, EU, JP

**Where You’ll Work**

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

**Travel Requirements**

This role requires occasional domestic/international travel (approximately 10%)

\#LI-Remote

\#LI-DM1

**Pay Range:**

$155,000.00-201,500.00 Annual

**Life at Insmed**

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

- Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
- Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

**_Current Insmed Employees: Please apply via the Jobs Hub in Workday._**

*Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our* [*Equal Employment Opportunity and Non-Discrimination Statement*](<https://insmed.com/documents/EEO-and-Non-Discrimination-Statement-of-Policy.pdf>) *on our Careers site.*

*It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.*

*Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.*

*Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at* [*TotalRewards@insmed.com*](<mailto:TotalRewards@insmed.com>) *and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.*

*Applications are accepted for 5 calendar days from the date posted or until the position is filled.*

AbbVie

Senior Manager, Regulatory Affairs Process Excellence

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

The **Senior Manager, Process Excellence within Regulatory Affairs**, is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations. This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements. Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

**Responsibilities:**

- Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved
- Triage RAIM issue records to determine severity, impact, and appropriate next steps
- Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance
- Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve AbbVie processes
- Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective
- May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed
- Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack
- Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations
- Partner with stakeholders to support effective communication, implementation, and adoption of process changes.
- This role will work a hybrid work schedule (3 days in office, 2 days remotely) from our Lake County, IL AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

- Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred. Certification a plus
- Required Experience: 8+ years of regulatory, pharmaceutical or device experience.
- Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
- Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows
- Experience supporting audit and inspection readiness in a regulated environment
- Strong organizational, analytical, communication, facilitation, and stakeholder management skills
- Ability to manage multiple priorities and work effectively across functions and levels
- Ability to influence without direct authority and work in a matrixed environment

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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

Sanofi US

Automation Engineer

**Job Title**: **Automation Engineer**

- Location: Swiftwater, PA

**About the Job**

Sanofi is an innovative global healthcare company with one purpose: to pursue scientific miracles to improve lives. Our team strives to transform the practice of medicine, connecting our science to communities in meaningful ways. Within our Sanofi Manufacturing & Supply Ambition, were redefining our strategy, culture, and processes to make a tangible impact worldwide.

In this role, you'll join the Manufacturing Systems & Automation department at our Swiftwater site, supporting directly the manufacturing system automation. The role will support implementation of changes to the automation systems, updating design documents, executing testing, troubleshooting events, and being a part of the site automation on-call support. The role will provide Subject Matter Expert (SME) level support of all automated process control systems used in licensed manufacturing (including dedicated clean utilities) of the building that the Automation Engineer has been assigned to. The position will be the Manufacturing Systems & Automation Site Support interface with Operations personnel, QA Compliance, Information Systems, Engineering, Maintenance and the site wide Automation Support technicians.

The Automation Engineer must exhibit strong customer communication skills and have in-depth technical knowledge of process control systems and equipment used in biotech/ pharmaceutical manufacturing and utility systems. This position will support the highly complex automated systems installed in the new and existing manufacturing facilities, security and its support systems.

Expected results from this position would include hands-on support of automated system in manufacturing (including Building Automation Systems), troubleshooting of automated process equipment and process systems, coordination of contractors, execution of site change controls, aiding in the investigation of process deviations and providing expertise for process evaluation and product improvements for better quality and yields. The role will provide improved response time to failures in manufacturing and implement site automation standard procedures and Global Engineering Practices.

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

**About Sanofi:**

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

**Main responsibilities:**

The Automation Engineer will oversee manufacturing automation systems within the whole site. Key responsibilities include :

- **System Integration:**
  - Ensure seamless integration of automation systems with digital applications to support production, quality control, and data management.
- **Deliverable Accountability:**
  - Ensure compliance with GMP and regulatory standards (C&Q), including user/functional/detailed specification development, test protocols, and system validation.
  - Work closely with the client to understand their needs and develop strategies tailored to their organization through site assessments.
- **Risk and Compliance Management:**
  - Identify and proactively manage risks.
  - Ensure compliance with GMP to minimize disruptions to timelines and costs.
- **Training and Support:**
  - Develop and deliver specialized training materials for staff to ensure proper operation and maintenance of automated systems.
  - Provide ongoing support post-implementation.
- **Collaboration and Documentation:**
  - Collaborate with Manufacturing, Supply Chain, Quality, Facilities, and Tech Transfer departments to capture and document detailed requirements.
- **Standards and Best Practices:**
  - Develop standards and best practices for development and validation activities.
  - Lead cross-functional teams through design reviews and user acceptance testing during the development change and validation process.
- **Operational Meetings:**
  - Participate in facility operational meetings to ensure facility reporting needs are met.
- **Operational Oversight:**
  - Oversee the daily monitoring, troubleshooting, and support of automation systems (PLCs, SCADA, DCS, and other control systems) to ensure continuous production with minimal downtime and maximum efficiency.
- **Continuous Improvement:**
  - Identify, propose, and implement process and system improvements to enhance automation performance, reduce costs, and improve flexibility in manufacturing operations.
- **Cross-Functional Collaboration:**
  - Work closely with engineering, production, quality, IT, and other cross-functional teams to ensure alignment of automation systems with production goals and regulatory requirements.
- **Compliance & Risk Management:**
  - Ensure that all automation activities comply with GMP, safety standards, and other relevant regulations. Lead efforts to manage risks associated with automation systems and address any compliance issues proactively.
- **On-Call Support:**
  - Be available to provide on call support during off-shift hours, based on a rotating schedule, to support manufacturing operations.

**About You**

**Basic Qualifications**

- Automation and Engineering: 2+ years of direct experience in automation systems and automation support within biopharma or related industries is preferred.
- Process Control Systems:Knowledge in systems like DCS (DeltaV), SCADA (Aveva), PLCs, and related automation technologies in a manufacturing context. Machine connectivity understanding with data acquisition from PLCs into higher level applications like Historian, ERPs, etc... using current technologies like OPC is preferred.

**Soft and Technical Skills:**

- Team Collaboration:Ability to collaborate effectively with cross-functional teams.
- Analytical Skills:Problem-solving abilities.
- Communication:Effective communication skills for engaging diverse stakeholders across projects.

**Education:**

- Bachelors degree in engineering, Electrical, Chemical, Mechanical, Automation, Computer Science, Biotechnology, Computer Sciences, and/or applicable technical field related to engineering in the biopharma sector. Relevant work experience may be substituted for the required college degree.

**Languages:**

- English:Proficiency in both written and spoken English.

**Why choose us?**

- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention andwellness programs and at least 14 weeks gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale

Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can [be found here.](<https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi>)

Pennsylvania

Novo Nordisk

Senior Process Engineer - API manufacturing

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

The Process Engineer position will support the site to onboard new API manufacturing programs. In addition, the role is expected to be a key technical resource supporting new chemical API process implementation.

**Relationships**

Reports to Associate Director, Operations

**Essential Functions**

- Independently lead or support assigned engineering projects from concept design through start-up
- Responsible for providing input on varying sizes of capital projects throughout all phases of the project lifecycle, including the development of user requirement specifications, process design, equipment and instrumentation specification/selection, equipment procurement, installation, commissioning/qualification and turn-over
- Provide manufacturing and research groups technical support as needed to assist with the day-to-day manufacturing and development activities including, but not limited to new molecule introduction activities (transfer and scale-up), operation and equipment optimization, equipment and process trouble-shooting and continuous improvement goals
- Support EHS activities including chemical and hazardous assessments including participation in PHAs and PSSRs
- Work with internal and external resources to develop and review engineering documentation, technical standards, SOPs, protocols, risk assessments and reports
- Develop, evaluate and implement cost effective engineering solutions for equipment, facility and utility systems
- Support process and automation system designs
- Promote a culture of safe and compliant design and operation
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

**Qualifications**

- Bachelor’s degree in an Engineering or Chemistry field of study from an accredited university required
  - Minimum of eight (8) years of relevant work experience to include engineering processes & design and operations support required, preferably in a pharmaceutical manufacturing environment
- Knowledge and experience with two (2) or more of the following required: process utility systems including water, solvent, waste, inert gas, glycol, syltherm and compressed air systems
- Knowledge of process and equipment design and installation required
- Strong understanding of engineering guidelines to include one or more of the following required: CFR, GEP, ASME BPE, ASTM E2500 and ISPE guidelines
- Direct experience and ability to start-up and trouble-shoot equipment required
- Possess excellent writing and communication skills and a demonstrated ability to work independently and with cross-functional teams required
- Ability to lead projects that include managing external vendors with development, design and testing activities is required
- Ability to provide technical leadership on multiple projects operating in parallel required
- Strong understanding of Good Manufacturing Practices (GMPs) a plus
- Experience working with capital engineering projects is preferred
- A working knowledge with pharmaceutical manufacturing process operations is preferred
- Knowledge and experience with the execution of commissioning and validation activities including FAT, SAT, TOP and IQ/OQ/PQ a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Virginia

BTS Senior Engineer, Technology I

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

The Sr. Engineer Technology I enables the full lifecycle of AbbVie's Digitalization of Software Life Cycle — from design and implementation through evidence collection, continuous monitoring, and inspection readiness. This is not a software testing or QA engineering role. This bridges regulation with technology functions for IT governance using modern tooling.

This role calls for a quality and compliance professional who is deeply technology-aligned — someone fluent in how CI/CD pipelines, source control platforms, test management systems, and artifact repositories work, and who uses that fluency to drive regulatory expectation through intelligent automation. The engineer translates between governance stakeholders and the engineering teams who build and maintain the tools.

**Responsibilities:**

- **IT controls design assurance end-to-end** — design, implement, maintain, and continuously improve SLC framework across technology systems and platforms, applying a patient-centric, risk-based approach aligned with GAMP® principles.
- **Drive controls automation** — identify opportunities to automate the collection, validation, and reporting of IT control evidence within CI/CD pipelines and integrated toolchains; embrace automation and electronic means over paper-based evidence, consistent with FDA/industry CSA guidance.
- **Leverage AI** — apply AI tooling to enhance control monitoring, trend analysis, and anomaly detection across regulated systems; understand the compliance and data integrity implications of self-learning systems and govern them accordingly.
- **Serve as the bridge compliance and technology teams** — translate between governance and regulatory requirements and the engineering teams responsible for tool configuration and pipeline design.
- **Partner with tool owners** — work directly with teams operating Jira, GitHub, JFrog, qTest, ServiceNow, and related platforms; embed controls at the source and ensure those tools produce the right evidence in the right form.
- **Maintain digital traceability** — own digital traceability records linking requirements, controls, system design elements, and verification evidence; ensure records are live, dynamic, and continuously audit-ready rather than static or paper-based.
- **Ensure data integrity by design** — apply ALCOA+ principles and data lifecycle controls across all governed systems.
- **Support audit and inspection readiness** — lead evidence preparation and coordinate remediation; ensure the team can respond confidently to regulatory inquiries supported by real-time, digital records.
- **Enable governance stakeholders** — surface interdependencies, communicate control status, and translate technical complexity into compliance-relevant language for leadership and governance audiences.
- **Contribute to continuous improvement** — support Validation 4.0 principles including quality by design, data integrity by design, and integrated environments; help evolve the controls assurance methodology as technology platforms and regulatory expectations change.

Qualifications

**Required:**

- Bachelor's Degree with 6 years' relevant experience; Master's Degree with 5 years'; PhD with 0 years'
- Demonstrated experience working in a regulated industry (pharmaceutical, medical device, or similar)
- Fluency with modern software development toolchains — GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB, and/or CI/CD platforms (Azure DevOps, AWS CodePipeline, or equivalent)
- Ability to translate regulatory requirements into technical specifications, acceptance criteria, and control configurations
- Experience embedding controls into DevOps workflows or software delivery pipelines
- Comfort operating at the boundary between governance stakeholders and engineering teams — able to communicate credibly in both directions
- Ability to learn and work in a fast-paced environment

**Preferred:**

- Familiarity with AI systems in a regulated context — including governance, validation, and data integrity considerations — is a plus

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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>)

Senior Engineer, Technology II (Data Engineering & Architecture)

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

The Sr. Data Engineer & Solution Architect serves as the principal designer for Operations Data organization, with a focus on cloud-native data lakehouse architecture, advanced data engineering, and Supply Chain data domains. This role is responsible for conceiving, designing, and implementing scalable, high-performance data solutions leveraging modern AWS Database & Analytics services, Apache Iceberg open table format, AWS Redshift, and Medallion Architecture principles. The Sr. Data Engineer & Solution Architect will drive Data Product-centric thinking and data mesh principles for the organization, partnering closely with Supply Chain functional and business stakeholders to deliver trusted, governed, and actionable data and dashboards across from Supply Chain domains. This role requires a deep combination of hands-on technical expertise, solution architecture, and the ability to communicate complex data strategies to both technical teams and cross functional stakeholders.

**Responsibilities:**

- Design, develop, implement and oversee legacy ETL and cloud-native data ingestion frameworks and end-to-end data pipelines leveraging AWS services including AWS Glue, Amazon S3, AWS EMR, AWS Lambda, and other ingestion / ETL technologies like Informatica; assess information needs and data flows to engineer scalable, reliable, and cost-effective solutions.
- Solution architect data need for the Operations Supply Chain analytical use cases using Apache Iceberg open table format, implementing Medallion Architecture to ensuring data quality, lineage, and accessibility.
- Build, optimize, and maintain AWS Redshift data warehouse solutions for Supply Chain analytical use cases, including the design of data products leveraging AWS Redshift aligned to enterprise analytics consumption patterns.
- Define, promote, and implement Data Product-centric architecture and data mesh principles from business domains; establish standards for data product design, ownership, discoverability, and interoperability to enable all analytical Dashboards and AI use cases.
- Partner with Supply Chain BTS (IT) functional and business stakeholders to understand and model critical data flows across from SAP and planning systems processes; translate complex ERP data structures into governed, analytics-ready data products within the lakehouse platform.
- Lead consultant technical data engineering team responsible for building the solutions; supervise team members as needed, remain accountable for team delivery and performance, and cultivate a culture of engineering excellence and continuous improvement.

Qualifications

**Required:**

- Bachelor’s Degree in Computer Science, Information Systems, Data Engineering, or a related field with 7+ years of experience in data architecture and data engineering; Master's Degree with 6 years' experience; or PhD with 2 years of experience.
- Deep, hands-on expertise with modern AWS Database & Analytics services including AWS Glue, Amazon S3, AWS EMR and related ingestion and transformation technologies like Informatica.
- Demonstrated hands-on experience with Apache Iceberg open table format or similar technologies for lakehouse architecture.
- Proficiency with AWS Redshift for enterprise data warehousing or similar Modern data warehousing platforms.
- Proven experience designing and implementing Medallion Architecture (Bronze/Silver/Gold layers) and Data Product frameworks; familiarity with data mesh principles including domain ownership, data product thinking.
- Familiarity with Supply Chain ERP systems, specifically SAP, and working knowledge of core Supply Chain data flows and data domains.
- Familiarity with Blue Yonder (formerly JDA) planning domain covering demand planning, supply planning etc. including understanding of the underlying data models and integration patterns with enterprise data platforms.
- Strong programming and query skills in ETL, SQL, Python, and Apache Spark/PySpark for large-scale data transformation, processing, and pipeline development.
- Solid knowledge of data governance frameworks, data cataloging using Alation or AWS Glue Data Catalog, metadata management, data lineage, and data quality practices; experience implementing enterprise-wide data governance policies and controls.
- Demonstrated ability to analyze complex business requirements, evaluate technical options, and deliver efficient, scalable, and cost-effective data solutions; proven experience operating with a high degree of autonomy in enterprise or regulated IT environments, balancing technical depth, architecture leadership, and senior stakeholder engagement.

**Preferred:**

- Knowledge of reporting tools such as PowerBI etc. is a plus for the role.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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>)

Application Engineer II (PAS-X) - SDF

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Responsible for ensuring reliable & consistent operation of identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus and Standards "Gatekeeper".

**Relationships**

Reports to Senior Project Manager – OFP.

**Essential Functions**

- Work primarily with production (shop floor) & corporate as a liaison ensuring application understanding & managing continuous improvement initiatives
- Present initiatives & information accurately & explain industry jargon in a clear manner for customers
- Support the identification of application requirements through relationship building & effective stakeholder management
- Gather information about stakeholders’ needs/process gaps & develop/implement action plans that support the production goals
- Provide input to product feature enhancements & process improvements
- Provide resolutions to system related issues & discrepancies
- Coordinate & oversee software upgrades & releases to applicable systems
- Coach & train colleagues & stakeholders in relevant areas
- Schedule & execute plans in coordination with manufacturing schedules
- Support projects that involve specified application solutions
- Maintain process application standards, specifications & maintenance plans
- Own self development & initiative to understand the site process control systems
- Support audits & inspections as SME for specified process applications
- Utilize the appropriate cLEAN® tools within the main areas of Systematic Problem Solving, process improvement, & project management
- Operate within compliance with a Quality Mindset that focuses on risk management & mitigation
- Implement effective Change Management
- Support Corporate, OFP, local IT & local stakeholder initiatives & projects
- Govern behaviour based on the Novo Nordisk Way
- Other accountabilities as assigned.

**Physical Requirements**

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

**Qualifications**

- Bachelor's Degree in IT/Engineering/related field or equivalent combination of education & experience required
- Minimum of eight (8) years of IT or engineering experience in process-based manufacturing, utility and/or packaging systems preferred
- Knowledgeable in the following applications or technologies: PAS-X, POInT, PLC, SCADA preferred
- Proven expertise, (e.g. project management) in planning/organization & project execution, follow-up & completion preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

North Carolina

Manufacturing Process Technician I

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Operate manufacturing equipment in order to achieve production goals.

**Relationships**

Reports to Shift Manager.

**Essential Functions**

- Set up, operate, monitor & control equipment, systems & processes associated with production /manufacturing lines
- Execution of production schedule to achieve production goals
- Maintain production areas & perform cleaning
- Actively participate in & support event response
- Review & author SOP’s & other documents, as required
- Assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
- Record/review production data in BPR’s and associated forms
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

**Qualifications**

- High school diploma or equivalent required
- Minimum of six (6) months manufacturing experience required
- Minimum experience requirement may be waived with military experience, a BioWorks/BioBlend certification/equivalent from an accredited college, or a current Novo Nordisk contractor that has 3 months of demonstrated performance in the relevant area)
- Experience working in an FDA regulated environment preferred
- Production/Manufacturing experience preferred
- Ability to read, write & understand product documentation & standard operating procedures with attention to detail required
- Computer literacy preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Process Specialist - Virginia

**About the Department**

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Provide process, technical and strategic support to the organization as the Site Subject Matter Expert (SME) for department. Lead and support various projects as required based on evolving business needs. Act as a coach/mentor to area Process Professionals. Communicate on behalf of Novo Nordisk with Vendors, Engineering Firms, etc. related to projects and technical issues. Complete assigned projects and project tasks within cost, quality, and schedule requirements. Present project status updates to Senior Management.

**Relationships**

Reports to Manager/Director. The role is responsible for collaborating with stakeholders related to assigned area as well as other stakeholders across the site and other NN sites.

**Essential Functions**

- Support senior leadership as part of the department management group through participating in strategic discussions and decision making
- Responsible for area content and process knowledge, periodic reviews, validation processes, and reporting
- Demonstrate technical knowledge of assigned processes to promote continuous improvement, increased productivity, and cost reduction
- Facilitate and provide technical oversight for assigned processes, including assessment of deviations, root cause analysis, validation and process changes/improvements
- Evaluate process/maintenance data to propose, guide and evaluate solutions for changes and continuous process improvements via Lean tools and Six Sigma methodologies
- Present as the technical expert for assigned processes to auditors/inspectors regarding complex subject matter
- Collaborates and shares best practices with other departments and other sites of NN
- Provide support to other areas in matters related to knowledge of assigned production/process area
- Responsible for identifying and implementing process needs and improvement opportunities
- Define and support the achievement of department goals according to company objectives and strategies
- Lead and provide guidance related to complex maintenance matters
- Communicate production and industry trends to team and shop floor to drive cGMP
- Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role.).

**Minimum Qualifications**

- Bachelor’s degree (engineering, technology or related field of study) from an accredited university required and minimum of eight (8) years of manufacturing experience preferably in a pharmaceutical manufacturing environment
- In lieu of Bachelor’s degree and eight (8) years of experience, may consider an Associate’s degree (engineering, technology or related field of study) from an accredited college or university with a minimum of ten (10) years of manufacturing experience
- In lieu of Bachelor’s degree and eight (8) years of experience, may consider a High School Diploma (GED) with a minimum twelve (12) years of manufacturing experience
- Thorough investigation and systematic problem-solving experience required
- LEAN manufacturing experience and training required
- Excellent written communication skills, investigative writing and computer skills required
- Ability to read, write and understand complicated product documentation and standard operating procedures with attention to high level concepts required
- Ability to drive continuous improvements via Lean tools and Six Sigma methodologies required
- Proven expertise in planning/organizing, managing execution, checking results, revising plans required
- Comprehensive knowledge of change control systems and Quality Management Systems (QMS) required
- Thorough validation knowledge and experience required (product/tech transfer preferred)
- General experience with regulatory audits/inspections required
- Thorough knowledge of relevant electronic manufacturing systems and master data required (ex: SAP, PAS-X, etc.)
- Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

GenScript

Enterprise AI Agent Development Engineer

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Title:** Enterprise AI Agent Development Engineer

**Supervisor:**  Head of AI for Industry, Digital & Intelligent Technology Center

**Location:**  Piscataway, NJ (Onsite)

**Compensation:**  Targeting $150,000 - $180,000 based on experience level.

**Key Responsibilities**

- Design, develop, test, and continuously optimize enterprise AI Agents.
- Build capabilities such as task planning, tool calling, and workflow orchestration using large language models.
- Integrate AI Agents with enterprise systems, including ERP, CRM, OA, supply chain, and order management systems, to automate cross-system business processes.
- Develop and optimize enterprise system interfaces and Agent tools.
- Collaborate with product and business teams to deploy AI Agent solutions in real-world enterprise scenarios.

**Qualifications**

- Master’s degree or above in Computer Science, Artificial Intelligence, Software Engineering, or a related field, and at least 3 years work experience.
- Strong software engineering fundamentals and proficiency in Java and Python.
- Experience in large language model application development, with an understanding of prompt engineering and function calling.
- Hands-on experience with Agent development frameworks, particularly LangGraph and Agent Scope.
- Familiarity with APIs, databases, microservices, and common enterprise system integration methods.
- Strong system design, problem-solving, communication, and collaboration skills.
- Fluency in Mandarin Chinese and English to collaborate effectively with internal and external stakeholders.

**Preferred Qualifications**

- Experience developing and deploying enterprise AI Agent solutions.
- Experience integrating ERP, CRM, OA, supply chain, or order management systems.
- Familiarity with MCP, OAuth 2.0, SSO, and RBAC.
- Experience with complex workflow orchestration, multi-Agent collaboration, or private deployment of large language models.

\#LI-EB1

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

New Jersey

AI Intern, Enterprise Agent Development

**About GenScript**

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

**Job Title:** AI Intern, Enterprise Agent Development

**Supervisor:**  Head of AI for Industry, Digital & Intelligent Technology Center

**Location:**  Piscataway, NJ (Onsite preferably, but open to US Remote for the right candidate)

**Compensation:**  Targeting $30 - $40 per hour based on experience level.

**Key Responsibilities**

- Design, develop, test, and continuously optimize enterprise AI Agents.
- Build capabilities such as task planning, tool calling, and workflow orchestration using large language models.
- Integrate AI Agents with enterprise systems, including ERP, CRM, OA, supply chain, and order management systems, to automate cross-system business processes.
- Develop and optimize enterprise system interfaces and Agent tools.
- Collaborate with product and business teams to deploy AI Agent solutions in real-world enterprise scenarios.

**Qualifications**

- Master’s degree or above in Computer Science, Artificial Intelligence, Software Engineering, or a related field
- Understanding of software engineering fundamentals and proficiency in Java and Python.
- Experience in large language model application development, with an understanding of prompt engineering and function calling.
- Hands-on experience with Agent development frameworks, particularly LangGraph and Agent Scope.
- Familiarity with APIs, databases, microservices, and common enterprise system integration methods.
- Strong system design, problem-solving, communication, and collaboration skills.
- Fluency in Mandarin Chinese and English to collaborate effectively with internal and external stakeholders.

\#LI-EB1

\#GS

**Benefits:**

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Process Maintenance Technician I

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you’ll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

- Leading pay and annual performance bonus for all positions
- All employees enjoy generous paid time off including **14 paid holidays**
- Health Insurance, Dental Insurance, Vision Insurance – effective day one
- Guaranteed 8% 401K contribution plus individual company match option
- Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance
- Life & Disability Insurance
- Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

Identify potential issues and support improvement of reliability of systems and equipment and minimize system and equipment downtime for the designated process. Assist in the operation of the assigned process supporting low to moderate complexity issues.

**Relationships**

Reports to Manager.

**Essential Functions**

- Actively improve performance & reliability of process equipment
- Restore function to equipment in an effective & technically correct manner
- Actively participate in & support Event Response
- Perform corrective & preventative maintenance on assigned process
- Operate, monitor, control equipment, systems & processes assigned
- Support & implement system/equipment reliability improvement projects
- Support & assist in all aspects of process operations
- Record & review production data in Batch Production Records (BPRs) & associated forms
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environments. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

**Qualifications**

- Associate’s Degree in Industrial Maintenance or relevant field required
- In lieu of Associate’s Degree may consider a High School diploma (or GED) with minimum of two (2) years of equipment maintenance experience required, preferably in a pharmaceutical manufacturing or related industry
- Knowledgeable in the following systems: Compressed Air, Electro-Mechanical controls, Electrical, Mechanical, Instrumentation and/or robotics preferred
- Ability & experience with automated records systems such as SAP, schematics, wiring diagrams & other technical documents preferred
- Computer literacy preferred
- Support planning & execution of process functions & assist in coordination of planned & corrective maintenance activities to ensure successful process performance a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Technician II, Engineering - Process

**About the Department**

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world.

What we offer you:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including **14 paid holidays**
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

**The Position**

A Production Technician's primary duty is to provide direct technical support to operations area as it relates to equipment. This role will work collaboratively with multiple functions and departments to ensure equipment and associated production systems operate in a safe, and quality-oriented manner. Responsibilities include: providing training and assessment support for equipment operation, set-up, changeover, and troubleshooting, providing recommendations and implementing solutions to resolve equipment and/or process problems in a timely manner, creating and revising GMP as it relates to equipment activities, supporting or owning work orders and preventative maintenance.

NOTE: This role works 6PM - 6:30AM on a 2/2/3 rotating schedule (Shift B)

**Relationships**

Reports to Manager or Supervisor.

**Essential Functions**

- Complete work under supervision by more experienced team members with increasing independence as experience, training, and job specific aptitude are gained
- Use judgment within generally defined guidelines to identify solutions to problems
- Interact with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments. Schedule self-performed work assigned at beginning of month and due by end of month
- Follow general instructions on routine work and detailed instructions of new work
- May design new approaches to problems encountered and use a wide application of complex principles, theories, and concepts in the specific field
- Use hand tools, power tools, and delicate testing equipment in performance of duties
- Complete non-routine repair work orders for regulated and unregulated systems
- Effectively document work performed following required documentation practices
- Be available and respond to site as part of the on-call rotation (optional for Calibration)
- Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreements
- Perform basic troubleshooting as it related to assigned job duties
- Work with shipping to send out equipment or standard for offsite vendor service and track status
- Contribute to the creation of maintenance and calibration procedures and update existing procedures to match best practices and lessons learned
- Identify and order spare or replacement parts for equipment utilizing inventory management system
- Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines
- Opportunity to contribute on Safety Committee, Environmental Engagement Committee, or other corporate responsibility areas
- Assist with onboarding new equipment and retiring obsolete equipment
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned

**Physical Requirements**

Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 25 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety engineering practices and procedures will be followed to minimize exposure, including clean room gowning.

**Qualifications**

- High school diploma with at least 3 years of relevant experience
- Intermediate Mechanical and Electrical Skills and Education
- Technical or Associate degree in maintenance related field, preferred
- Must be able to read and understand English-written job instructions and safety requirements
- Technical Requirements:
  - Ability to see and hear, read, and write clear English
  - Mechanical and electrical aptitude
  - Ability to gown for entry in clean room environment
  - Ability to operate within a clean room environment
  - General facility repair, maintenance, and up-keep
  - Ability to understand basic training and apply the knowledge to work activities
  - Ability to apply basic math
  - Ability to use Excel, Word, and other office systems
  - Ability to review data to ensure data is well organized with complete documentation
  - Ability to problem solve and execute/monitor corrective action independently
  - Ability to cross-train on techniques across multiple groups
- Behavioral Requirements:
  - Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner
  - Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  - Ability to cooperate with coworkers within an organized team environment or work alone

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Indiana

Jazz Pharmaceuticals, Inc.

Associate Director, AI Development Lead

**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:**

The Associate Director, AI Development Lead is a strategic technical leader responsible for advancing Jazz Pharmaceuticals' enterprise AI capability and driving measurable business value through artificial intelligence and machine learning. Reporting to the Director, Enterprise AI, this role will spend much of its time in delivery — designing systems, writing production-quality code, reviewing colleagues’ work, and guiding a small team of AI developers working across traditional data science (AI/ML) and modern Generative AI (GenAI) approaches.

AI development at Jazz follows a hub-and-spoke operating model. Business functions (spokes) own use-case prioritization, stakeholder alignment, early-stage ideation, and some proof-of-concept development. The central Digital Enterprise Capabilities (DEC) team (hub) serves as an advisory partner at any stage and progressively takes on a hands-on development role as solutions mature — ensuring production-grade standards for data readiness, model quality, code maturity, and reliability. The business is accountable for deciding what gets built; DEC owns how it gets built and deployed.

The role will also partner with the Director, Enterprise AI and the VP of Data, AI, and Research to help shape Jazz's enterprise AI strategy — operating model, governance, technology stack, best practices, and policies — and serve as a trusted subject-matter expert to teams across Jazz who are evaluating use cases, prioritizing initiatives, and vetting vendors. As the team and capability mature, the balance of the role will naturally evolve toward broader technical oversight and a larger share of strategic work, while continuing to direct the most important technical decisions.

**Essential Functions/Responsibilities**

- Build and ship end-to-end ML solutions — data ingestion, feature engineering, model training, evaluation, deployment, and monitoring — across supervised, unsupervised, and other classical/statistical learning paradigms.

- Design and ship end-to-end GenAI solutions — including retrieval-augmented generation (RAG) systems, agentic workflows, vector stores, and integrations with foundation model APIs.

- Across Gen AI and AI/ML, write production-quality code (Python or related languages/frameworks as needed), with attention to readability, modularity, scalability, performance, and maintainability.

- Design and review architectures across Gen AI and AI/ML solutions that are secure, reusable, and rigorous. Work with the Enterprise AI Architect to ensure your designs follow our architectural standards.

- Debug, profile, and optimize solutions — including cost, latency, accuracy, and reliability trade-offs.

- Support deployment and post-deployment operations, including CI/CD, observability, model monitoring, drift detection, and incident response.

- Establish and continuously refine technical standards for development: reference architectures, design patterns, coding conventions, evaluation methodologies, and reusable components.

- Lead a small team of AI developers across traditional ML and Generative AI, setting clear technical direction, priorities, and quality expectations.

- Be accountable for the quality and outcomes of the team's work: solution design, code and model quality, documentation, and delivery.

- Mentor team members through code & design review, both informal and formal feedback; build technical depth and ownership across the team.

- Plan and sequence delivery work in partnership with stakeholders, balancing scope, technical risk, and timelines.

- Help recruit, onboard, and grow AI talent as the team expands.

- Serve as a go-to technical advisor to teams across Jazz, many of them non-technical, helping them: understand how AI works, how to ensure human-in-the-loop review and how to increase and optimize adoption of solutions while maintaining responsible and ethical use.

- Evaluate AI use cases and proposed solutions for technical feasibility, data readiness, value, and risk.

- Use expertise to support business in prioritizing AI initiatives based on business impact, technical feasibility, bandwidth constraints, solution complexity, and scalability. Within agreed upon product priorities, decide resource allocation and development activities for the team.

- Vet AI vendors and platforms in collaboration with our Enterprise AI Architect, as well as Infrastructure and Digital Security teams. Together, conduct technical due diligence on solution feasibility, data handling, security, transparency, and overall operational maturity. During such evaluations, this role will focus on solution fit for the use-case, overall solution practicality, and vendor knowledge of AI’s capabilities and limitations.

- Support build-vs-buy decisions with a clear-eyed view of time-to-value, total cost of ownership, extensibility, and vendor risk.

- Partner with the Director, Enterprise AI and the VP of Data, AI, and Research to help shape and execute Jazz's enterprise AI strategy, including operating model, governance, technology stack, best practices, and policies.

- Contribute to the maturation of the AI capability through reference architectures, MLOps practices, evaluation frameworks, and reusable components that make future delivery faster and more reliable.

- Help define and apply Responsible AI practices — explainability, evaluation, privacy, security, and risk management — across the work the team delivers and supports.

- Collaborate with Data Engineering, Enterprise Architecture, Infrastructure, InfoSec, and Compliance to ensure AI solutions meet enterprise standards.

- Build credibility quickly with senior technical and business stakeholders through effective communication and deep expertise.

**Required Knowledge, Skills, and Abilities**

- Demonstrated ability to lead, mentor, and be accountable for the technical work of others.

- Demonstrated experience leading offshore or near shore development teams required.

- Hands-on technical depth in building and shipping ML/GenAI solutions to production.

- Proficiency in writing production-quality code and designing AI/ML architecture.

- Strong understanding of core machine learning algorithms and statistical modeling techniques, model evaluation, and real-world deployment considerations.

- Proficiency in one or more programming languages (e.g. Python, R) and ML frameworks (such as TensorFlow, PyTorch, scikit-learn).

- Strong understanding of modern Generative AI concepts and approaches: LLMs, RAG, fine-tuning, agentic patterns, evaluation, and guardrails.

- Significant hands-on experience with at least one major cloud platform (AWS, GCP, or Azure); AWS or GCP preferred.

- Familiarity with AI governance and risk frameworks.

- Excellent communication skills with ability to explain complex technical concepts in clear, non-technical terms, and a demonstrated ability to influence and guide stakeholders across various levels of an organization.

**Required/Preferred Education and Licenses**

- Bachelor’s degree or equivalent practical experience in a quantitative or technical field required. Advanced degree or equivalent preferred.

- 5–7 years of relevant experience in AI, machine learning, or data science required, 10+ years preferred.

- Experience in pharmaceutical, life sciences, or another regulated industry strongly preferred.

- Experience evaluating and integrating third-party AI/ML solutions and vendor platforms strongly preferred.

\#LI-Remote

*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: $153,600.00 - $230,400.00

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>).

Massachusetts

Manager, eQMS Technologies

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

The Manager, eQMS Technologies supports data-driven quality and compliance decisions by advancing analytics, AI-enabled insights, measurement solutions, and electronic quality management system capabilities across RDQA, R&D, and Enterprise Quality. This role partners with Quality, Business Technology Services, and process owners to translate business needs into requirements, improve data quality and accessibility, and deliver dashboards, metrics, and advanced analytics that support continuous improvement, global regulatory compliance, informed decision-making, and proactive risk management.

- Support the development and execution of quality analytics and AI roadmaps aligned with RDQA, R&D, and Enterprise Quality priorities.
- Build and maintain automated reporting, dashboards, KPI frameworks, and eQMS health metrics to monitor quality process performance and compliance.
- Develop advanced analytics and AI capabilities, including trend, anomaly, and predictive risk signals, to identify quality and compliance risks earlier.
- Partner with process owners and BTS to translate business needs into requirements, data products, and insight-driven actions.
- Establish data definitions, quality controls, and governance for key quality datasets and metrics.
- Enable self-service use of dashboards and insights through training, playbooks, and documentation.
- Review and approve SLC documentation to support compliant use of data and models in regulated environments.
- Support eQMS system ownership responsibilities, including system health monitoring, release/change coordination, issue escalation, user access/process support, and partnership with BTS and process owners to ensure systems remain fit-for-purpose, compliant, and aligned with business needs.

Qualifications

Required:

- Bachelor’s Degree in Pharmacy, Engineering, Computer Science, Data/Analytics, Business, or relevant course of study
- 4–6 years of experience in quality systems, engineering, data/analytics, or business support in a regulated environment
- Demonstrated experience developing metrics, dashboards, and analytical insights for process performance and compliance monitoring
- Working knowledge of data fundamentals (data modeling, data quality, governance) and analytical methods (descriptive/inferential statistics, trend analysis)

Preferred:

- Experience with BI and analytics tooling (e.g., Power BI or similar) and query languages (SQL); scripting/analysis in Python, R or similar is a plus
- Experience applying machine learning/AI techniques to operational quality problems (e.g., risk prediction, signal detection, text analytics) and understanding of model lifecycle considerations (monitoring, bias, drift)
- Experience implementing or enhancing computerized QA/eQMS solutions with a focus on data enablement and insights
- Knowledge of tools and techniques that can be leveraged into actionable activities and influence decision making
- Knowledge of Risk Management principles to help organization focus on the most impactful activities
- Quality Systems knowledge and related experience
- Travel: Yes, 10 % of the Time

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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>)

Senior Engineer, Technology I

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

Work collaboratively with technology and business groups to conceive, design, engineer, and implement full stack software solutions that solve significant scientific or business problems. Deliver production-grade web applications and services across a modern React/TypeScript front-end, Python and Node back-end services, federated Apollo GraphQL APIs, and NoSQL data platforms, deployed as containerized workloads on Kubernetes/EKS. Investigate, identify, and implement state-of-the-art platforms and engineering practices that drive productivity and efficiency gains across multiple business areas. Contribute to the advancement of full stack engineering practice and develop productive collaborations across multiple disciplines.

**Responsibilities:**

- Conceive, design, engineer, and implement full stack software solutions—spanning React/TypeScript front-ends, Python and Node.js services, Apollo GraphQL federated subgraphs, and NoSQL data stores—by studying information needs, conferring with users, and analyzing systems flow, data usage, and work processes. Routinely demonstrate initiative and creativity in developing technology solutions.
- Serve as technical expert or lead projects/programs and technical staff to develop, test, and implement significant new products, operational improvements, or new approaches to problems at the division/business unit level.
- Design and build responsive, accessible web experiences in React and TypeScript, using modern tooling (Vite, GraphQL codegen, TanStack/Redux Toolkit, react-hook-form, zod) and shared design systems.
- Design, implement, and evolve Apollo GraphQL subgraphs and the federated supergraph; author schemas, resolvers, and data-loading patterns that scale across multiple services and clients.
- Build and operate Python back-end services, including agent/LLM-integrated services, exposing them safely and observably to front-end and downstream consumers.
- Architect and operate NoSQL data models (e.g., graph databases such as Neo4j, document/key-value stores, and caches such as Redis), ensuring performance, resilience, and appropriate consistency guarantees for the workloads served.
- Package and deploy applications using containerization (Docker) and orchestrate workloads on Kubernetes/Amazon EKS via Helm; define production-grade manifests, charts, and service configurations.
- Build and maintain CI/CD pipelines with GitHub Actions to automate build, test (unit, integration, and end-to-end with Playwright), security scanning, container image publishing, supergraph composition, and deployment across environments.
- Instrument services and clients for observability using tools such as Datadog (APM/tracing and Browser RUM) and use those signals to analyze and resolve technical problems using disciplined problem-solving methods.
- Contribute to the advancement of the function by studying state-of-the-art tools, techniques, and computing equipment; participate in educational opportunities and professional organizations.
- Demonstrate high proficiency across a wide range of technologies and platforms related to software design and development, programming languages, data integration, data storage, network connectivity, and virtualization/cloud environments.
- Operate with high autonomy and productivity, requiring only minimal direction from or interaction with supervisor. Accountable for total project scope, budget, completion within budget constraints, and scheduled completion date. Accountable for successful and timely completion of all tasks/projects under direct and matrix control.
- May initiate new areas of investigation that are meaningful, reliable, and can be incorporated directly into a scientific or business activity.

Qualifications

**Required:**

- Bachelor's Degree with 6 years' experience; Master's Degree with 5 years' experience; PhD with 0 years' experience.
- Possess thorough theoretical and practical understanding of full stack software engineering.
- Proven, hands-on experience delivering production applications with Python and React + TypeScript.
- Working experience with NoSQL databases (graph, document, or key-value —e.g., Neo4j, DynamoDB, MongoDB, Redis), including data modeling and performance tuning.
- Practical experience with containerization (Docker) and orchestration on Kubernetes, preferably Amazon EKS, including Helm chart authoring.
- Experience authoring and maintaining CI/CD workflows in GitHub Actions, including containerized build/publish and automated test pipelines.
- Strong TypeScript proficiency, including type-driven API design and shared type/codegen workflows between client and service.
- Proven implementation of creative technology solutions that advanced the business.
- Excellent written and oral English communication skills.

**Preferred:**

- Demonstrated experience designing, implementing, and consuming Apollo GraphQL APIs; experience with Apollo Federation / subgraph architectures strongly preferred.
- Experience with AWS services (S3, IAM, STS), Node.js server frameworks (Hapi/Apollo Server), Python service frameworks and packaging (uv, pydantic, httpx), Redis-based caching, observability tooling (Datadog APM/RUM), Playwright end-to-end testing, and secure SDLC practices in a regulated (GxP) environment.
- Exposure to LLM/agent-based application development and integration with internal AI SDKs.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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>)

Merck & Co.

Director, Operations - Drug Product (Biologics)

**Director Operations for Drug Product**

Do you aspire to secure a critical role in the production of biologics-based medicines? Are you excited to lead dynamic teams in a state-of-the-art facility that brings transformative biotech treatments to patients globally? We invite you to become a part of our journey as the Director Operations for Drug Product. This role offers you the chance to contribute to the site's development and wield technical leadership to ensure successful GMP manufacturing.

**Principle Roles & Responsibilities / Accountabilities**

- The Director, Operations – Drug Product plays a critical part in strategic project realization of the Wilmington Biotech facility, a new hi-potent facility in our company's Biologic manufacturing network, ensuring that site’s mission and objectives are effectively achieved, consistent with our company's requirements to ensure compliance, safety and reliable supply to our customers.
- As a key member of the Site Leadership Team, you'll have the opportunity to shape site and organizational strategies, overseeing drug product manufacturing for commercial and new product introductions.
- Be part of facility start-up to manufacture high-potent products, eg antibody drug conjugates (ADCs)
- You will work collaboratively with cross-functional teams to streamline technology transfers and commercial approvals, meanwhile nurturing and empowering your operations team.
- You'll get to foster a culture of continuous learning and improvement, leading or supporting various site functional and cross-functional structures for departmental alignment.
- Tackling resource constraints and needs, you will champion operational and technical excellence for efficient production and implement Lean principles for process optimization.
- Upholding our Manufacturing Division Quality Management System (QMS) requirements, you will manage relevant quality topics, and ensure permanent inspection readiness.
- You will oversee financial forecasts and workload for departmental cost improvements, aligning with capital and expense targets while contributing to sustainability and cost reduction initiatives.
- You will have the chance to leverage digital tools for operational efficiency and informed decision-making, keeping pace with emerging digital technologies relevant to manufacturing processes.
- You will be accountable for achieving onsite Key Performance Indicators (KPIs), monitoring and striving to improve performance metrics related to hiring, uptime, training, change controls, investigations, CAPAs, yield, volume, production cadence, operational availability, and more.

**Qualification And Experience**

**Required Experience and Skills:**

- A degree or equivalent in Engineering, Science, Technical, or other relevant fields: Bachelor’s degree + 12 years industry experience Or Masters + 10 years Or PhD + 8 years
- 6 or more years demonstrated leadership ability and experience managing, coaching, and mentoring high-performing cross function teams.
- Demonstrated experience in a biotech/vaccines/pharma manufacturing site, project, or other relevant roles, specifically drug product sterile manufacturing.
- Demonstrated experience in manufacturing clinical and commercial products.
- Understanding of cGMP requirements for commercial high-potent ADC manufacturing of drug product

**Preferred Experience and Skills:**

- Sterile manufacturing leadership & operations, with preferred multi-product experience.
- A leader who inspires, coaches, and fosters a high-performance organizational culture.
- A continuous learner who cultivates a culture of ongoing development within your team.
- An innovative thinker with excellent decision-making and problem-solving skills.
- Experienced in leading highly effective cross-functional teams with a passion for shaping the future of our organization.
- Capable of influencing and building relationships across organizational layers, as well as externally with partners.

Delaware

Associate Director, Technical Operations - Small Molecule Drug Substance

We have an exciting opportunity for an **Associate Director, Technical Operations – Drug Substance** at our Elkton Site in Virginia, USA.

*At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.*

*Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.*

*At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.*

The successful candidate will provide **technical leadership and operational support** for the **startup, technology transfer, validation, and ongoing commercial manufacture** of active pharmaceutical ingredients (APIs).

This role is responsible for **leading technical activities across assigned processes and projects**, supporting the capital project and facility startup phase through to **commercialization and lifecycle management**. The Associate Director will ensure **safe, compliant, and reliable process performance**, while driving continuous improvement and technical excellence.

**Key Responsibilities**

**Technical Leadership**

- Recognized subject matter expert in **Drug Substance process support, and commercial manufacturing**
- Provide **technical oversight and hands-on leadership** for API manufacturing processes, including:
  - Chemical synthesis
  - Purification
  - Crystallization and drying operations
- Support the **Capital Project Team**, contributing to **design, commissioning, qualification, and startup readiness**
- Lead **process scale-up, technology transfer, and validation (pre-PPQ, PPQ)**  activities for assigned processes
- Drive improvements in **process performance, yield, robustness, and impurity control**
- Provide technical guidance on:
  - Process chemistry
  - Reaction performance
  - Critical process parameters and control strategies
- Analyze technical data and **support decision-making for process performance and improvements**
- Identify and escalate risks, proposing **practical, science-based solutions**

**Technology Transfer**

- Lead and execute **technology transfer activities** for assigned processes across internal sites and external partners
- Support development and execution of **tech transfer plans aligned with project timelines**
- Provide technical support for:
  - Raw material evaluation
  - Process fit and manufacturability
  - Scale-up readiness [\[](<https://mydrive.merck.com/personal/egandan_merck_com/_layouts/15/Doc.aspx?sourcedoc=%7BBD8EB341-2E05-49E1-B7A9-A3582FCF916B%7D&file=Elkton%20%20AD%20Drug%20Substance%20JD.docx&action=default&mobileredirect=true>)
- Ensure accurate **process documentation, knowledge transfer, and batch record readiness**
- Support **process validation and continued process verification**

**Operational Excellence**

- Partner with Manufacturing to ensure **safe, efficient, and reliable plant performance**
- Provide direct technical support to:
  - **Campaign preparation, execution, and follow-up**
  - Process troubleshooting during manufacturing
- Lead and support **deviation investigations, OOS, and CAPA**, applying structured root cause analysis
- Monitor **process performance and cycle times**, identifying improvement opportunities
- Drive **continuous improvement initiatives** for yield, cycle time, and cost
- Support **process optimization and debottlenecking activities**

**Regulatory & Compliance**

- Ensure assigned processes operate in compliance with **cGMP and regulatory expectations**
- Support **inspection readiness and audit activities**
- Contribute to **regulatory submissions and responses**, including data generation and technical input
- Ensure **data integrity and adherence to quality and safety standards**
- Maintain compliance from **startup through commercial operations**

**Cross-functional Leadership**

- Collaborate with **Engineering, Capital Projects, R&D, Quality, Supply Chain, and Manufacturing**
- Act as a **technical representative for assigned processes** within cross-functional teams
- Support **technology transfer and process improvements across the network**
- Participate in interactions with **external partners and CMOs** as required
- Contribute to **technical reviews and governance forums**

**People, Capability & Business Leadership**

- Lead and develop a team of **technical specialists and engineers**
- Provide **coaching, technical guidance, and performance feedback**
- Support **resource planning and execution of departmental priorities**
- Contribute to **budget tracking and departmental administration**
- Support **recruitment, onboarding, and capability development initiatives**

**Qualifications**

- Degree (BSc/BEng/Masters) or higher in **Chemistry, Chemical Engineering, or related discipline**
- Significant experience (typically 10+ years) in:
  - **API process development and/or manufacturing**
- Strong background in:
  - Process chemistry and scale-up
  - Process, equipment, and cleaning validation
- Working knowledge of:
  - cGMP manufacturing operations
  - Regulatory expectations and inspection readiness
- Experience with:
  - Deviation management and investigations
  - Electronic batch records and process systems (e.g., DeltaV)
- Exposure to **capital projects, CQV, and facility startup**
- Strong analytical, problem-solving, and communication skills
- Ability to work effectively across **cross-functional teams and multiple priorities**

**Our Culture**

We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe breakthrough innovation happens when **experienced leaders empower talented teams in an inclusive environment**.

So, if you are ready to:

- **Support delivery of new Drug Substance manufacturing capability**
- **Drive operational and technical excellence in API production**
- **Develop your leadership capability in a high-impact environment**