Executive Director, CMC Drug Product Development
Beeline Medicines, Boston, MA, United States
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 Executive Director, CMC Drug Product Development serves as a senior technical and strategic leader accountable for the end‑to‑end chemistry, manufacturing, and controls development of the company's drug candidates from early development through regulatory submission. This leader integrates formulation, process development, clinical supply strategy, and CMC regulatory strategy into a cohesive product development roadmap. Reporting to the Chief Technical Operations Officer, this individual will drive cross‑functional collaboration with clinical, regulatory, and quality teams, oversee CDMO partnerships, and ensure CMC deliverables meet the scientific, regulatory, and business requirements at each stage of development.
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.
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
Define and execute the overall CMC product development strategy for programs, ensuring alignment with clinical development timelines and regulatory submission milestones (IND, CTA, NDA/BLA).
Lead cross‑functional CMC teams across formulation, process development, analytical development, and clinical supply to ensure integrated, on‑time delivery of all CMC activities.
Oversee the development of drug product processes from Phase 1 through Phase 3, ensuring scalability, robustness, and regulatory compliance at each stage.
Serve as the primary CMC author and scientific owner for drug product sections of IND, CTA, NDA/BLA, and regulatory meeting packages; lead responses to FDA and international agency questions on CMC topics.
Evaluate and select CDMO/CMO partners; establish and manage technical and operational governance with external manufacturing organizations for drug product.
Drive technology transfer activities, manufacturing process validations, and clinical supply chain continuity to ensure uninterrupted supply for clinical trials and preparations for commercial launch.
Integrate Quality by Design (QbD) principles, Design of Experiments (DoE), and risk management frameworks into product development decisions.
Provide technical leadership on formulation strategy for complex dosage forms including oral solid, parenteral, and novel drug delivery technologies.
Establish and manage the CMC product development budget, resource plans, and project timelines; proactively flag risks and propose mitigation strategies to senior leadership.
Evaluate in‑licensing candidates and acquisitions from a CMC manufacturability perspective; contribute to technical due diligence and partnership term discussions.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or closely related discipline.
15+ years of progressive pharmaceutical/biopharmaceutical CMC experience within pharmaceutical and or biotechnology industry.
5 years of people management experience.
Demonstrated track record of successfully leading CMC programs from early development through regulatory approval across small molecule and/or biologic modalities.
Comprehensive knowledge of ICH guidelines (Q1–Q14), FDA and EMA CMC regulations, and experience authoring and defending CMC sections of regulatory filings.
Proven experience managing and governing CDMO/CMO relationships at a technical and operational level, including performance management and change control oversight.
Strong command of Quality by Design (QbD), Design of Experiments (DoE), and risk‑based approaches to pharmaceutical development.
Experience operating in pre‑commercial, resource‑lean biotech environments with the agility to build programs and infrastructure simultaneously.
Experience supporting or leading due diligence assessments, business development evaluations, or partnership negotiations from a CMC technical perspective.
Proven track record of operating effectively in pre‑commercial, resource‑constrained environments – balancing strategic vision with hands‑on execution and infrastructure building.
Experience managing cross‑functional stakeholder relationships at the executive level, with the ability to influence without authority and align diverse teams around shared program goals.
Skilled in budget ownership, headcount planning, and CDMO/external partner governance, with a demonstrated ability to deliver on time and within resource constraints.
Strong written and verbal communication skills, with a track record of authoring high‑quality regulatory documents, scientific reports, and executive‑level presentations.
Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.
Salary Range The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance.
$272,000 - $299,250 USD
Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company)
20 accrued days combined time off (PTO/Sick), 12 company holidays, and winter recharge
Flexible work arrangements / hybrid schedule
Health Savings Account (HSA)
Benefits are subject to eligibility requirements and plan terms. Additional details 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.
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Job Summary The Executive Director, CMC Drug Product Development serves as a senior technical and strategic leader accountable for the end‑to‑end chemistry, manufacturing, and controls development of the company's drug candidates from early development through regulatory submission. This leader integrates formulation, process development, clinical supply strategy, and CMC regulatory strategy into a cohesive product development roadmap. Reporting to the Chief Technical Operations Officer, this individual will drive cross‑functional collaboration with clinical, regulatory, and quality teams, oversee CDMO partnerships, and ensure CMC deliverables meet the scientific, regulatory, and business requirements at each stage of development.
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.
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
Define and execute the overall CMC product development strategy for programs, ensuring alignment with clinical development timelines and regulatory submission milestones (IND, CTA, NDA/BLA).
Lead cross‑functional CMC teams across formulation, process development, analytical development, and clinical supply to ensure integrated, on‑time delivery of all CMC activities.
Oversee the development of drug product processes from Phase 1 through Phase 3, ensuring scalability, robustness, and regulatory compliance at each stage.
Serve as the primary CMC author and scientific owner for drug product sections of IND, CTA, NDA/BLA, and regulatory meeting packages; lead responses to FDA and international agency questions on CMC topics.
Evaluate and select CDMO/CMO partners; establish and manage technical and operational governance with external manufacturing organizations for drug product.
Drive technology transfer activities, manufacturing process validations, and clinical supply chain continuity to ensure uninterrupted supply for clinical trials and preparations for commercial launch.
Integrate Quality by Design (QbD) principles, Design of Experiments (DoE), and risk management frameworks into product development decisions.
Provide technical leadership on formulation strategy for complex dosage forms including oral solid, parenteral, and novel drug delivery technologies.
Establish and manage the CMC product development budget, resource plans, and project timelines; proactively flag risks and propose mitigation strategies to senior leadership.
Evaluate in‑licensing candidates and acquisitions from a CMC manufacturability perspective; contribute to technical due diligence and partnership term discussions.
Perform other duties and responsibilities as assigned.
Qualifications
Education: Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or closely related discipline.
15+ years of progressive pharmaceutical/biopharmaceutical CMC experience within pharmaceutical and or biotechnology industry.
5 years of people management experience.
Demonstrated track record of successfully leading CMC programs from early development through regulatory approval across small molecule and/or biologic modalities.
Comprehensive knowledge of ICH guidelines (Q1–Q14), FDA and EMA CMC regulations, and experience authoring and defending CMC sections of regulatory filings.
Proven experience managing and governing CDMO/CMO relationships at a technical and operational level, including performance management and change control oversight.
Strong command of Quality by Design (QbD), Design of Experiments (DoE), and risk‑based approaches to pharmaceutical development.
Experience operating in pre‑commercial, resource‑lean biotech environments with the agility to build programs and infrastructure simultaneously.
Experience supporting or leading due diligence assessments, business development evaluations, or partnership negotiations from a CMC technical perspective.
Proven track record of operating effectively in pre‑commercial, resource‑constrained environments – balancing strategic vision with hands‑on execution and infrastructure building.
Experience managing cross‑functional stakeholder relationships at the executive level, with the ability to influence without authority and align diverse teams around shared program goals.
Skilled in budget ownership, headcount planning, and CDMO/external partner governance, with a demonstrated ability to deliver on time and within resource constraints.
Strong written and verbal communication skills, with a track record of authoring high‑quality regulatory documents, scientific reports, and executive‑level presentations.
Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.
Salary Range The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job‑related factors permitted by law. A discretionary annual bonus and long‑term incentive award (e.g., equity) may be available based on individual and Company performance.
$272,000 - $299,250 USD
Benefits
Medical, Dental & Vision insurance (employee premiums 100% covered by company)
20 accrued days combined time off (PTO/Sick), 12 company holidays, and winter recharge
Flexible work arrangements / hybrid schedule
Health Savings Account (HSA)
Benefits are subject to eligibility requirements and plan terms. Additional details 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.
#J-18808-Ljbffr