Regulatory

Insmed Incorporated

Associate Director, Regulatory Affairs (CMC)

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, Regulatory Affairs CMC on the Regulatory Affairs CMC team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, Regulatory Affairs CMC, EMEA, you’ll have responsibility for leading CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for assigned development and post approval programs to achieve regulatory approvals in the EMEA region.

**What You'll Do:**

In this role, you’ll have the opportunity to plan and coordinate regulatory submissions to support projects in development and commercial applications, including lifecycle management of products in the EMEA region.

You’ll also:

- Work closely with cross-functional teams to ensure short and long term objectives are achieved in a proactive and time efficient manner.
- Lead the development of CMC background documentation for consultation with the EMA, MHRA and other regulatory authorities.
- Identify key CMC content requirements and author the CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions based upon internal technical documents provided by Tech Operations or from vendor supplied documents to support clinical studies and product registrations, ensuring they meet current regulatory standards and are of high quality, consistent, and complete.
- Establish product specific strategies to ensure successful development of CMC submission packages to support early development, registration and life cycle management.
- Have accountability for reviewing and approving all CMC change control documents and disposition of proposed changes relating to products in the EMEA region, scheduling submissions as necessary based on such changes.
- Provide interpretation of applicable EMA/ICH/WHO, and other country specific regulations to ensure the compliance of CMC content within regulatory filings.
- Keep abreast of all pertinent regulations and guidance documents for pre and post approval submissions.

**Who You Are:**

You have aminimumof a Bachelor's degree along with 5-7 years of pharmaceutical development and regulatory CMC experience in the biotechnology or pharmaceutical industry. Biologics and inhalation drug product development knowledge in EMEA region is desirable. You are or also have:

- Prior experience within a GMP environment with a firm understanding of industry regulations and best practices.
- A solid understanding of EU/ICH regulations and other country specific guidelines for small molecules and/or biologics.
- Knowledge of global regulatory guidance documents and regulations with emphasis on the interrelationship between CMC and all other development.functions (for example, clinical supplies, qualification of impurities via toxicology testing, etc) as related to the overall global regulatory strategy.
- Understanding and interpretation of complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.

**WhereYou’llWork**

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 eventswillbe expected.

**Travel Requirements**

Minimal travel expected

**Pay Range:**

$164,000.00-213,000.00 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.*

New Jersey

Beeline Medicines

Associate Corporate Counsel, Contracts

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Associate Corporate Counsel, Contracts, provides legal support for the drafting, review, and negotiation of a broad range of commercial agreements, ensuring contracts appropriately protect company interests and comply with applicable laws and internal policies. Partners closely with Procurement, R&D, and other business functions to keep contracting moving at the pace the business needs, while maintaining and improving templates, playbooks, and negotiation guidelines that scale legal support across the organization. Advises internal stakeholders on contractual risk and obligations, escalating higher-risk or novel issues to senior legal leadership as appropriate. This role is well suited to a contracts attorney who enjoys high-volume, fast-paced transactional work in a growing life sciences company.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Draft, review, and negotiate a variety of commercial agreements, including CDAs, MSAs, CRO/vendor agreements, and consulting agreements.
- Partner with Procurement, R&D, and other business functions to support contracting needs and timelines.
- Maintain and improve contract templates, playbooks, and negotiation guidelines.
- Advise internal stakeholders on contractual risk, obligations, and compliance considerations.
- Support the contract lifecycle management system, ensuring accurate tracking and record-keeping.
- Assist with due diligence and contract review for business development and licensing transactions.
- Escalate higher-risk or novel contract issues to senior legal leadership as appropriate.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: JD from an accredited law school required; active bar membership in good standing.
- 5 years of relevant contracts/transactional experience, in-house or at a law firm, ideally within the life sciences industry preferred.
- Strong knowledge of commercial contract law and life sciences-specific agreement types (CDA, MSA, clinical trial agreements) with familiarity with contract lifecycle management systems.
- Working knowledge of intellectual property and confidentiality considerations in commercial agreements.
- Understanding of key risk allocation and indemnification concepts in vendor and CRO contracts.
- Ability to work independently while knowing when to escalate risk to senior counsel.
- Sound judgment prioritizing a high volume of concurrent contracting requests.
- Ability to drive process improvements in templates and playbooks that scale legal support.
- Strong drafting, negotiation, and client-counseling communication skills.
- Ability to clearly explain contractual risk and options to non-legal business stakeholders.
- Effective at building relationships across Procurement, R&D, and other business functions.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$181,000 - $235,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Massachusetts

Senior Director, Regulatory Affairs CMC – Biologics

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Director, Regulatory Affairs CMC – Biologics provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's biologics assets within the immunology and inflammation (I&I) portfolio, including monoclonal antibodies and other large molecule therapeutic modalities. This role is responsible for developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing and post-approval lifecycle management, serving as the company's foremost authority on biologics CMC regulatory science. The Senior Director collaborates closely with Process Development, Analytical Sciences, Quality, and external biologics CMOs to ensure that programs are developed, characterized, and submitted in alignment with FDA, EMA, and global Health Authority expectations for biological products. As a senior leader within the Regulatory Affairs organization, this individual also contributes to cross-functional regulatory strategy and plays a foundational role in shaping the company's biologics CMC regulatory infrastructure.

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Develop and lead the CMC regulatory strategy for all biologics assets in the I&I portfolio, from IND/CTA through BLA and MAA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product.
- Author, review, and oversee the preparation of biologics CMC sections of global regulatory submissions in ICH CTD format, including INDs/CTAs, BLAs, MAAs, supplements, and post-approval variations, with accountability for scientific quality, completeness, and regulatory defensibility.
- Serve as the company's primary regulatory authority and strategic partner for biologics Process Development, Upstream and Downstream Manufacturing Sciences, Analytical Development, Formulation, and Quality functions on all CMC regulatory matters.
- Lead Health Authority interactions related to biologics CMC topics, including FDA Type B and Type C meetings (including BPD meetings), EMA Scientific Advice meetings, and written responses to CMC deficiency letters and information requests from global regulatory agencies.
- Provide expert regulatory interpretation of FDA and EMA biologics CMC guidance documents and ICH Q-series guidelines applicable to large molecules, including ICH Q8, Q9, Q10, Q11, Q12, and Q13, and advise development teams on process characterization, comparability, and control strategy regulatory acceptability.
- Lead post-approval CMC change management strategy for biologics programs, including PACMP development, Prior Approval Supplements (PAS), CBE filings, and EU/global variation submissions related to manufacturing process changes, site changes, and analytical method updates.
- Oversee regulatory aspects of biologics technology transfer activities, including biosimilar comparability assessments, new CMO site qualification, and regulatory filing strategies for site-to-site manufacturing transfers.
- Provide regulatory guidance on biologics-specific CMC considerations, including cell line development, cell banking, upstream and downstream process validation, biophysical and functional characterization, and extended characterization strategies.
- Contribute to regulatory due diligence evaluations of biologics licensing candidates or acquisition targets, assessing CMC regulatory risk, comparability study adequacy, and submission readiness.
- Tracks CMC regulatory deliverables and submission timelines across all biologics programs, ensuring proactive identification of dependencies, risks, and upcoming milestones to keep cross-functional teams aligned and submission-ready.
- Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.
- Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Advanced degree (PhD, MS, or PharmD) in biochemistry, molecular biology, pharmaceutical sciences, immunology, or a related biologics-relevant discipline strongly preferred or equivalent years of experience.
- Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry
- Deep and comprehensive expertise in biologics CMC regulatory strategy, including cell line development, upstream and downstream process development and validation, biophysical characterization, analytical method validation, and drug product formulation and fill-finish for parenteral biologics.
- Extensive experience authoring and overseeing biologics CMC sections of global regulatory submissions, including INDs/CTAs, BLAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format.
- Demonstrated track record of leading FDA and EMA biologics CMC Health Authority meetings, including BPD (Biologics Product Development) meetings, pre-BLA meetings, and strategic management of CMC deficiency letter responses
- Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12/Q13 guidelines, FDA biologics CMC guidance (including CDER and CBER guidance for therapeutic biologics), and EMA quality guidance applicable to monoclonal antibodies and other biological entities.
- Proven experience managing biologics-specific CMC regulatory challenges, including comparability study strategy, reference standard lifecycle management, specification negotiation, and extended characterization regulatory justification.
- Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities.
- Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
- Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.
- Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive regulatory decision-making.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$242,000 - $313,500 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Senior Director, Regulatory Affairs CMC – Small Molecule

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and Controls (CMC) activities related to the company's small molecule assets within the immunology and inflammation (I&I) portfolio. This role is responsible for developing and executing CMC regulatory strategies from early clinical development through NDA filing and post-approval lifecycle management, serving as the company's foremost authority on small molecule CMC regulatory science. The Senior Director partners with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure that CMC programs are designed, documented, and submitted in full alignment with FDA, EMA, and global Health Authority expectations. As a senior leader within the Regulatory Affairs organization, this individual also contributes to the broader regulatory strategy, and plays a key role in shaping the company's regulatory affairs infrastructure

**Work Arrangement & Location:**

**Hybrid -** This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as **Tuesday and Wednesday**. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

**Essential Duties and Responsibilities:**

- Develop and lead the CMC regulatory strategy for all small molecule assets in the I&I portfolio, from IND/CTA through NDA filing, including post-approval lifecycle management and labeling strategy for drug substance and drug product.
- Author, review, and oversee the preparation of CMC sections of global regulatory submissions in ICH CTD format, including INDs, CTAs, NDAs, MAAs, Type II variations, and supplements, with accountability for quality, completeness, and regulatory defensibility.
- Serve as the company's primary regulatory authority and strategic partner for small molecule Technical Development, Process Chemistry, Analytical Development, Formulation Sciences, and Quality functions on all CMC regulatory matters.
- Lead Health Authority interactions related to small molecule CMC topics, including FDA Type B and Type C meetings, EMA Scientific Advice meetings, and written responses to CMC deficiency letters and information requests from global regulatory agencies.
- Provide expert regulatory interpretation of FDA, EMA, and ICH CMC guidance documents applicable to small molecules, including ICH Q8, Q9, Q10, Q11, and Q12, and proactively advise development teams on design space, process validation, and control strategy regulatory acceptability.
- Lead post-approval CMC change management strategy for small molecule programs, including SUPAC assessments, Prior Approval Supplements (PAS), Changes Being Effected (CBE) filings, and ex-US variation submissions.
- Oversee regulatory aspects of small molecule technology transfer activities, including new CMO onboarding, site-to-site comparability, and associated regulatory filing updates.
- Establish and maintain CMC regulatory SOPs, templates, and document management workflows specific to small molecule programs, ensuring compliance with ICH CTD, eCTD, and applicable electronic submission requirements.
- Contribute to regulatory due diligence evaluations of small molecule licensing candidates or acquisition targets, providing CMC regulatory risk assessment and readiness analysis.
- Tracks CMC regulatory deliverables and submission timelines across all small molecule programs, ensuring proactive identification of dependencies, risks, and upcoming milestones to keep cross-functional teams aligned and submission-ready.
- Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.
- Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.
- Perform other duties and responsibilities as assigned

**Qualifications:**

- Education: Advanced degree (PhD, MS, or PharmD) in organic chemistry, pharmaceutical sciences, analytical chemistry, or a related small molecule-relevant discipline strongly preferred.
- Minimum of 12+ years of CMC regulatory affairs experience in the pharmaceutical or biotech industry preferred
- Deep and comprehensive expertise in small molecule CMC regulatory strategy, including drug substance (API) synthesis and control, drug product formulation and manufacturing, and analytical method development and validation for oral, parenteral, and other dosage forms.
- Extensive experience authoring and overseeing small molecule CMC sections of global regulatory submissions, including INDs/CTAs, NDAs, MAAs, and post-approval supplements and variations in ICH CTD/eCTD format.
- Demonstrated track record of leading FDA and EMA CMC-focused Health Authority meetings, including preparation of briefing documents and strategic management of written responses to CMC deficiency letters
- Comprehensive knowledge of ICH Q8/Q9/Q10/Q11/Q12 guidelines, FDA small molecule CMC guidance documents (e.g., SUPAC, process validation, container closure), and EMA quality guidance applicable to small molecule chemical entities.
- Proven experience managing CMC regulatory aspects of technology transfer, new CMO qualification, and site change regulatory filing strategies for small molecule programs.
- Strong command of post-approval CMC change management regulations, including SUPAC categories, PAS/CBE filing requirements, and ex-US variation frameworks.
- Demonstrated ability to lead and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex regulatory or scientific priorities.
- Experience navigating organizational ambiguity and change; capable of defining structure, establishing priorities, and scaling functional capabilities in alignment with evolving corporate strategy.
- Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.
- Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations; balances clarity, diplomacy, and scientific precision

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$242,000 - $313,500 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Senior Director, Regulatory Strategy – Global Regulatory Lead

**About Beeline Medicines:**

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.

**Job Summary:**

The Senior Director, Regulatory Strategy – Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for assigned programs in the immunology and inflammation (I&I) therapeutic area, with a particular focus autoimmune indications. This role serves as the primary regulatory strategist and Health Authority relationship lead for assigned programs, guiding development teams in the design of regulatory-sound development plans, optimal filing strategies, and Health Authority engagement. The Senior Director provides a global perspective across FDA, EMA, and other major regulatory jurisdictions, ensuring that regulatory strategy is proactively integrated into all aspects of early clinical and translational development. As a key member of the Regulatory Affairs leadership team, this individual also contributes to the development of the company's regulatory infrastructure, capabilities, and organizational best practices for program oversight.

**Work Arrangement & Location:**

**Remote -** This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need.

**Essential Duties and Responsibilities:**

- Develop and lead integrated global regulatory strategies for assigned pipeline programs in the I&I portfolio, encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development planning, and regulatory pathway optimization across major global jurisdictions including FDA, EMA, PMDA, and others.
- Serve as the primary regulatory strategist for assigned program teams, providing expert guidance on development plan design, regulatory risk identification, filing sequencing, and Health Authority engagement strategy.
- Lead the preparation and execution of regulatory meetings, including management of timelines, briefing document development, strategic meeting preparation, and agency interaction management; translate Health Authority feedback into actionable development recommendations.
- Develop and maintain integrated regulatory development plans (iRDPs) and regulatory timelines for all assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program milestones.
- Lead IND, CTA, NDA and BLA submissions, regulatory planning and submission of pediatric development plans.
- Provide strategic input to clinical protocols, non-clinical study designs, and early CMC development activities to ensure regulatory acceptability and alignment with global development strategy.
- Monitor and interpret evolving FDA and global regulatory guidance, precedent regulatory decisions, and competitive landscape intelligence relevant to I&I development programs and proactively integrate insights into pipeline regulatory strategy.
- Evaluate and leverage expedited regulatory pathway opportunities for pipeline programs, including Breakthrough Therapy Designation (BTD), Fast Track Designation, PRIME designation (EMA), and Orphan Drug Designation where applicable.
- Partner with Regulatory Affairs CMC, Clinical Development, Non-Clinical Sciences, Bioanalytics, and Translational Sciences teams to ensure that cross-functional development activities are regulatory-strategy aligned from the earliest stages of development.
- Contribute to regulatory due diligence activities for pipeline asset evaluations, in-licensing candidates, and business development targets, assessing regulatory risk profiles, development pathway viability, and filing readiness.
- Maintain appropriate trackers of regulatory activities
- Concise, clear and frequent communication with cross functional team. This position requires maturity, finesse and leadership to lead the cross-functional team, and high level of strategic acumen and finesse to define and lead regulatory interactions
- Assess resource needs to support the assigned programs and with manager, participate in the development of the budget for assigned programs
- Perform other duties and responsibilities as assigned.

**Qualifications:**

- Education: Advanced degree (PhD, PharmD, or master's level) in a relevant life sciences discipline required.
- Minimum of 12+ years of regulatory affairs experience in the pharmaceutical or biotech industry preferred, with at least 5–7 years of direct responsibility for global regulatory strategy leadership on clinical development programs
- Deep expertise in global regulatory strategy development for biologics and/or small molecule therapeutics, with demonstrated experience developing regulatory plans across FDA, EMA, and additional global jurisdictions from pre-IND through post approval.
- Extensive experience preparing and leading Health Authority interactions, including FDA pre-IND, Type B, and Type C meetings and EMA Scientific Advice meetings, with a strong track record of productive agency relationships and strategic translation of feedback.
- Thorough knowledge of FDA regulations (21 CFR Parts 312 and 314/601), EMA regulatory frameworks, ICH E8(R1), ICH E9(R1), and applicable guidance documents relevant to early clinical development in I&I or autoimmune disease indications.
- Prior experience in immunology, inflammation, autoimmune disease, or a related therapeutic area is strongly preferred; knowledge of lupus regulatory landscape and precedent regulatory decisions is a meaningful advantage.
- Strong strategic thinking skills, intellectual curiosity, and the ability to synthesize complex scientific and regulatory information into clear, actionable regulatory development recommendations.
- Demonstrated ability to operate independently, driving execution of regulatory plans with agility and efficiency, while exercising sound judgment in stakeholder engagement, including proactively keeping leadership appropriately informed and involving senior management at key decision points.
- Able to manage multiple concurrent priorities with focus, efficiency, and sound judgment, balancing competing timelines and development milestones in a matrix biotech organization, with an appreciation for the visibility and criticality of programs in a small-company environment.
- Exceptional written and verbal communication skills with demonstrated ability to translate complex regulatory, scientific, or operational content for diverse audiences, including executive leadership, Health Authorities, and cross-functional partners.
- Demonstrated ability to communicate operational information into clear, actionable insights, providing decisive direction to teams and driving efficient, aligned execution across functions.
- Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams, board-level stakeholders, and external regulatory agencies.
- Adept at facilitating productive dialogue in high-stakes meetings, Health Authority interactions, and multi-party collaborations; balances clarity, diplomacy, and scientific precision.
- Strong active listening skills and the ability to synthesize input from diverse perspectives into clear, actionable communications that build alignment and drive regulatory decision-making.

**Salary Range:**

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range

$242,000 - $313,000 USD

**Benefits:**

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

- Competitive health and wellness coverage (structure and premiums vary by country)
- Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
- Flexible work arrangements / hybrid schedule

*Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.*

**Equal Employment Opportunity:**

*Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.*

**Reasonable Accommodation:**

If you require a reasonable accommodation to participate in the application or interview process, please contact careers@beelinemedicines.com to request an accommodation. We are committed to providing equal access to all candidates.

**Privacy**

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at [Privacy Policy - Beeline Medicines](<https://beelinemedicines.com/privacy-policy/>)

Nationwide

Ocugen, Inc.

In-House Clinical Research Associate

Description

**Purpose**

The **In-House Clinical Research Associate** supports the planning, execution, and closeout of Ocugen clinical studies to ensure study quality, timelines, and regulatory compliance. These activities are performed in accordance with the study protocol, Ocugen standard operating procedures (SOPs), ICH/GCP guidelines, and applicable regulatory requirements.

**Responsibilities**

- Support study start-up, execution, maintenance, and close-out activities for assigned clinical trials.
- Assist with investigator/site identification, feasibility, and recruitment activities.
- Develop and maintain the study document version tracker to ensure document control and version accuracy.
- Upload study documents in the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
- Tracks Investigational Product shipments, returns, destruction and ensures appropriate documentation is filed in the TMF.
- Track and maintain: Subject enrollment, Bioanalytic sample inventory, shipments, and receipt, database queries and resolution.
- Support CRAs and CTMs with study management activities, including vendor oversight, Investigator meeting planning, scheduling study team meetings to include agenda and meeting minutes.
- Coordinate with CRAs to review, maintain, and reconcile essential regulatory and study documents to ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable regulations.
- Perform routine TMF quality control reviews and coordinate reconciliation activities with field CRAs to ensure inspection readiness and document completeness.
- Supports field CRA(s) and investigational sites with regulatory submissions, IRB/IEC communications, and study-related documentation requirements.
- Serve as a point of contact for investigational sites regarding study questions, documentation, timelines, and operational support as needed.
- Manage and track subject travel reimbursement.
- Coordinate documents for site activation, prepare Investigational Site Green Light form for CTM sign off.
- Assist in the preparation and maintenance of study operational documents, including study plans, monitoring guidelines, site manuals, templates, and training materials.
- Review informed consent forms and essential documents for completeness, quality, and compliance.
- Collaborate with cross-functional teams and vendors to support study deliverables and project goals.
- Identify and escalate study risks, issues, and out-of-scope activities to study manager as appropriate.
- Ensure study activities are conducted in compliance with study protocols, Clinical Management Plans, SOPs, and applicable regulatory requirements.
- Support inspection and audit readiness activities as needed.
- Supports study budget tracking and invoice reconciliation activities as requested
- Perform ongoing eTMF maintenance activities including document filing, QC review, reconciliation, tracking of missing documents, and follow-up with study teams and investigational sites to ensure TMF completeness and inspection readiness.
- Supports preparation and collection of study documentation and data required for safety reviews as applicable
- Proactively identifies risks, developing and implementing mitigation plans as applicable.
- May assist in developing policies and procedures (SOPs).
- Perform additional responsibilities as assigned.

Qualifications

- Excellent communication and collaboration skills with a team-oriented approach.
- Experience with eTMF, CTMS and EDC, (MS Project or Smart sheets timelines desired).
- CRO/vendor management experience is preferred
- Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 desired.

**Working Conditions**

- This position operates in an office setting, 5 days per week in-person with occasional travel (up to 20%)
- Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

*Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.*

Pennsylvania

Atom Bioscience and Pharmaceutical Co., Ltd.

Sr. Director/VP Clinical Development and Medical Monitoring

**Sr. Director/VP Clinical Development and Medical Monitoring**

Atom Therapeutics is a fast-growing innovative drug company focused on development of best-in-class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late-stage clinical development for treatment of chronic gout. Another small molecule ABP-745, for anti-inflammatory and autoimmune conditions, has completed Phase 1 clinical trials in the US and demonstrated good pharmacokinetics and safety. A multicounty Phase 2 study with ABP-745 for treatment of acute gout flares is ongoing and a second multicounty study for ASCVD will be starting shortly. We are currently seeking a highly motivated leader to become part of our US clinical development team at Atom Therapeutics. This role will be based in the San Francisco Bay Area. Salary and benefits will be comparable with peers in the biotech industries in USA and China.

**Job Title: Sr. Director/VP Clinical Development and Medical Monitoring**

Department: Clinical Development

Reports To CEO

Base: Newark CA. In office work required.

**Position Purpose:**  
This role will be a strategic leader possessing extensive experience in advancing clinical development and medical monitoring. With a strong medical and science background and an overall expertise in product value chain, the successful candidate should have a close collaboration with and an in-depth understanding of research and commercial functions. With awareness of external innovation competition, a candidate should be able to provide differentiation in clinical strategy to win the market.

**Key Responsibilities**

1. Leads clinical development strategies, including Phase I through III, life cycle management, safety responsibilities, and scientific interactions. Ensures that all clinical trials are in keeping with approved timelines and budgets.

2. Manage the day-to-day activities of the ongoing clinical studies and oversee and coordinate the work of clinical CROs.

3. Track and organize the clinical research developments and data analysis of relevant products that the company is monitoring.

4. Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

5. Manage clinical medicine, operations, registration, pharmacovigilance (PV), and data statistics-related matters. Organize and coordinate with various departments to ensure timely completion.

**Education**

• Doctor of Medicine degree

**Experience:**

- US Medical license 8+ years of direct experience in Pharma or Biotech with hands on experience in international new drug development. Very proficient in ICH guidelines and FDA requirements.
- 8+ years Director level or above in clinical development with Pharma or biotech.
- Experience working with development of inflammatory and cardiovascular drugs.
- Specific experience leading Phase I, II and III clinical trials on the global level, including a strong experience in managing patient compliance during trials.
- Extensive experience dealing with FDA review experts, clinical KOLs, and physician experts. Good understanding of competitive market and unmet needs of the patient to deliver differentiated new products for treatment.

**Skills:**

- With broader view of the whole process, has in-depth understanding in the scientific field of early research which includes target screening, drug discovery, transfer medical and disease/therapeutic, clinical needs and clinic practices.
- Capable of providing differentiation in clinical strategy in the competition environment.
- Outstanding communication skills when internal facing with CEO and research and commercial team; and when external facing with investors, KOLs and CROs. Good people management skills are a must.
- Strong in actions and know- how in the implementation and execution of responsibilities.
- Good knowledge and understanding of Statistics work.

**Salary Range:**

$250,000 to $375,000 per year, depending on qualifications and experience

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Equal Opportunity Employer

California

ImmunityBio, Inc

Clinical Research Associate, In-House

**Company Overview**  
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.  
**Why ImmunityBio?**

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

• Work with a collaborative team with the ability to work across different areas of the company.

• Ability to join a growing company with professional development opportunities.

**Position Summary**

The Clinical Research Associate, In-House (IH) will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, support for process improvement, collection of essential documents and overall clinical trial support.

**Essential Functions**

- Facilitate study specific inspection readiness initiatives including tracking and maintaining ImmunityBio ClinOps study personnel list and training records
- Support development of new process and system implementations that impact assigned studies and IH team functions
- Identify process inefficiencies, gaps and provide process improvement recommendations to Trial Maintenance leadership
- Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
- Review and update study-related materials track feasibility/start-up activities
- Create regulatory document templates, oversee and support collection of essential documents during site start-up and as needed throughout the study
- Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
- File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
- Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
- Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial
- File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
- Perform content review and post approval review of documents filed to the TMF
- Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
- Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers
- Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
- Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
- Submit purchase requisitions to Enterprise Resource Planning (ERP) System
- Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
- Provide data listings and compile clinical study report documents to support medical writing activities
- Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
- Support clinical operations safety reporting activities including distribution to sites, tracking, IRB submission and related document filing
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

**Education & Experience**

- Bachelor’s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years’ clinical research experience) required; or
- Associate’s degree with 7+ years’ experience as a Clinical Trials Associate (or 10+ years clinical research experience) required

**Knowledge, Skills, & Abilities**

- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
- Excellent written/oral communication skills
- Strong organizational and multi-tasking skills
- Maintain corporate confidentiality at all times
- Ability to set priorities and independent decision making
- Ability to work independently as well as in teams

- Anticipate issues, identify process gaps and work to proactively and independently provide solutions

- Independent thinker and persuasive communicator
- Detail oriented, with solid organization and time management skills
- Knowledge of drug development process
- Computer literacy: EDC, eTMF, CTMS, etc.
- Working knowledge of ICH E6, and the Code of Federal Regulations

**Working Environment / Physical Environment**

- This position works on site in Dunkirk, NY.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.

$85,000 (entry-level qualifications) to $93,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

New York

Controlled Contamination Services

Director of Operations - GMP/Cleanroom Operations

**_Controlled Contamination Services_**  (Controlled) *has been a national provider of facility solutions, technical and decontamination services, since 1993. Our clients are in the Life Sciences, Technology, IT, Defense and Aerospace industries. Utilizing state of the art strategies, processes and human capital, Controlled ensures the highest degree of service and integrity for the sensitive environment we support;*  **_impacting those_**   **_industries that impact the world._**

**POSITION PURPOSE:**  
The Director of Operations is a leadership role that oversees cleaning operations and quality programs of specific accounts or group sites. The role is responsible for defining, coordinating and facilitating projects and ensuring the success of the accounts operations.

**MAJOR AREAS OF RESPONSIBILITY:**

- Continually monitor the cleanroom cleaning operations to ensure all activities are completed promptly and correctly.
- Responsible for staff development in areas such as cGMP training, technical skills, safety, and performance management. This includes hiring, completing annual performance reviews, and providing professional development opportunities.
- Plan, organize, and lead projects to improve efficiency and productivity and implement best practices in business management.
- Establish project deliverables based on project goals, quality goals, and company priorities.
- Apply project management tools, processes and principles to enable project success.
- Maintain project calendar, develop agendas, record minutes and action items and facilitate meetings.
- Identify and resolve project issues.
- Identify deviations and follow through on corrective and preventative actions (variances).
- Follow Good Manufacturing Practices and maintain a cGMP document program.
- Ensure that there is a minimum inventory level of standard stock materials.
- Assist in the cross training of other Controlled Contamination Services personnel.
- Represent the company at customer meetings along with sales manager and their regional manager.
- Ensures accurate time keeping and labor law compliance
- Manage region’s P&L and financial performance by reviewing and analyzing financial statements and data, operating reports, budget variance reports, and other appropriate financial information to monitor attainment of financial goals
- All other duties as defined by your supervisor

**PRIMARY RESULTS ACCOUNTABLE FOR ACHIEVING:**

- Demonstrate excellent leadership and communication skills
- Demonstrates excellent documentation skills, and adhere to all GMP regulations
- Demonstrates excellent conflict resolution skills, and maintain confidentiality
- Ability to stay calm and rational under pressure
- Adheres to all policy and conduct standards and embraces the culture of Controlled
- Must have a high level of attention to detail and excellent time management skills
- Must be proficient with cleaning chemical components and safety requirements.

**EDUCATION AND/OR EXPERIENCE:**

- Bachelor's degree in business administration or related field.
- 5-7 years of experience in the janitorial, cleaning, or related field is preferred.
- 1-3 years supervising the work of others required.

**SKILLS REQUIRED:**  
Must have and be able to consistently apply the following skills at the levels indicated to produce assigned results:

- Communication Skills
- Customer Service Skills
- Initiative Skills
- Problem Solving Skills

**PHYSICAL REQUIREMENTS:**  
Required to spend on-the-job time on the following physical activities:

- Stand
- Walk
- Lift/Climb
- Driving from Account to Account
- Talk/Hear
- Use hands to finger, handle or feel
- Reach with hands or arms
- The Weight or Force requirement in this position is: Up to 30 pounds

**VISION REQUIREMENT:**

- This position requires to have close vision (clear vision at 20 inches or less), and color vision (ability to identify and distinguish colors).
- Depth perception (three-dimensional vision, ability to judge distances and spatial relationships)
- Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus)

**_Controlled Contamination Services is an equal opportunity employer – vets/disability._**