Associate Director, CMC Product Development

BioSpace; Boston (MA); Hybrid; USD 198,000 - 211,000; Full time

Benefits offered by this job

Health and wellness coverage

Paid time off

Hybrid schedule

Job summary

Beeline Medicines in Boston, MA seeks an Associate Director, CMC Product Development – Small Molecule to lead formulation and drug product development for clinical candidates. You will supervise cross‑functional teams, manage CDMOs, and drive DoE/QbD programs from early screening through Phase 3 and regulatory filings.

The role requires a PhD with 7+ years in small molecule development, strong communication, and a track record of delivering high‑quality CMC outcomes in biotech settings.

Qualifications

• Ph.D. in Pharmaceutical Sciences or closely related field.
• 7+ years in small molecule drug product development.
• Lead formulation and drug product development across multiple clinical phases.
• Deep solid oral dosage form development experience.
• Experience authoring IND/IMPD/NDA filings and regulatory responses.
• Proven ability to manage external partners including CDMOs.

Responsibilities

• Lead formulation development and drug product process development for small molecules.
• Oversee CDMO relationships and cross‑functional team oversight.
• Contribute to regulatory submissions and risk assessment workflows.
• Apply QbD/DoE to define CQAs, CPPs, and design spaces.
• Support clinical supply planning and tech transfer activities.

Skills

Program leadership

CDMO management

Regulatory submissions

Communication

Cross-functional collaboration

Problem solving

Education

Ph.D. in Pharmaceutical Sciences

Job description

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.

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 Director, CMC Product Development – Small Molecule is a senior pharmaceutical scientist and individual contributor responsible for formulation development, drug product process development, and manufacture of clinical supplies in support of small molecule drug candidates. Reporting to the Executive Director, CMC Product Development, this individual is the primary technical owner for drug product development activities on assigned programs, driving work from early formulation screening through Phase 3 and registration. This role carries no direct reports but serves as the key scientific interface with CDMO drug product partners and cross‑functional CMC teams. It requires hands‑on expertise in small molecule formulation science and manufacturing, direct CDMO technical management experience, and the ability to deliver high‑quality CMC outcomes independently in a pre‑commercial biotech environment.

Work Arrangement & Location

Hybrid

The 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

• Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing.
• Oversee drug product process development and scale‑up for solid oral dosage forms (tablets, capsules) and other small molecule delivery formats, including process characterization, manufacturing process optimization, and tech transfer to CDMO sites.
• Serve as the primary technical interface with CDMO drug product teams for assigned programs, providing day‑to‑day scientific oversight of formulation and manufacturing campaigns, batch record review, and deviation resolution.
• Author and contribute to drug product sections of regulatory submissions (IND, IMPD, NDA) including formulation descriptions, manufacturing process narratives, container‑closure justifications, and drug product control strategies.
• Integrate Quality by Design (QbD) principles and Design of Experiments (DoE) into formulation and process development decisions, establishing critical quality attributes (CQAs), critical process parameters (CPPs), and design spaces.
• Oversee drug product stability programs in collaboration with Analytical Development, including protocol design, shelf‑life determination, and stability data interpretation in support of regulatory submissions and label claims.
• Support packaging development and container‑closure system selection for clinical drug product presentations, including compatibility assessment, extractables/leachable considerations, and child‑resistant packaging requirements.
• Contribute to clinical supply planning by providing manufacturing timelines, batch size projections, and drug product release schedules to the Clinical Supply Chain function in support of trial startup and enrollment milestones.
• Evaluate drug delivery technology options and novel dosage form strategies for pipeline candidates, providing formulation feasibility assessments and manufacturability input during candidate selection and early development planning.
• Operate as a self‑directed pharmaceutical sciences contributor — independently managing formulation study plans, CDMO deliverable timelines, and CMC documentation while keeping cross‑functional teams and leadership aligned on program status, risks, and decisions.
• Perform other duties and responsibilities as assigned.

Qualifications

• Education: Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a closely related discipline preferred, or equivalent industry experience in pharmaceutical analytical development.
• 7+ years of pharmaceutical drug product development experience focused on small molecules in pharmaceutical or biotechnology industry
• Demonstrated track record of serving as the primary scientific lead on formulation and drug product process development programs across multiple clinical phases.
• Deep expertise in solid oral dosage form development (immediate release, modified release, amorphous dispersions), including excipient selection, compatibility, and manufacturing process development for tablets and capsules.
• Experience authoring drug product sections of INDs, IMPDs, and NDA filings and contributing to FDA or EMA responses on formulation, manufacturing, and drug product control strategy topics.
• Proven ability to operate as a high‑impact individual contributor in a pre‑commercial, resource‑constrained environment — executing against multiple program deliverables simultaneously, operating with scientific independence, and contributing to the build‑out of functional infrastructure and processes.
• Skilled in managing external partner relationships including CDMOs and contract laboratories, with hands‑on experience in technical oversight, work order management, change control, deviation resolution, and performance monitoring at the working level.
• Strong written and verbal communication skills, with the ability to clearly present scientific data, development recommendations, and program updates to senior leadership and cross‑functional partners.
• Effective collaborator with a track record of building productive working relationships across CMC functions, Clinical Development, Regulatory Affairs, and Quality in a team‑oriented environment.
• Organized and detail‑oriented communicator who can manage competing priorities, proactively flag risks, and keep cross‑functional stakeholders aligned on timelines and deliverable status.

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

$197,905 - $210,514 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 [e-mail] 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