Associate Director, CMC Synthetic Chemistry

BioSpace; Durham (NC); Hybrid; USD 200,000 - 258,000; Full time

Benefits offered by this job

Health and Wellness

Paid time off

Hybrid schedule

Job summary

Beeline Medicines in the United States is seeking an Associate Director, CMC Synthetic Chemistry – Small Molecule to lead hands-on development, optimization, and scale-up of API routes. You will partner with CDMOs and cross-functional teams to advance candidates from development through GMP manufacture.

This role requires deep organic and process chemistry expertise, ability to work independently in a pre-commercial biotech environment, and strong communication with Regulatory, Quality, and IP

Qualifications

• Ph.D. in Organic Chemistry preferred or equivalent industry experience in pharmaceutical process development.
• 7+ years of API development and process chemistry in pharma/biotech.
• Experience leading synthetic chemistry programs from development to GMP manufacture.

Responsibilities

• Lead design, evaluation, and optimization of synthetic routes for APIs, ensuring robust, scalable manufacturing processes.
• Oversee process development campaigns from lab scale to kilo-lab and pilot plant operations.
• Interface with CDMO teams, reviewing batch records and addressing deviations quickly.
• Contribute to drug substance sections of regulatory filings and risk-based DoE studies.
• Collaborate on supplier qualification and IP strategy with cross-functional partners.

Skills

API process chemistry

CDMO collaboration

Scale-up experience

DoE studies

Education

Ph.D. in Organic Chemistry or equivalent experience

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.

Job Summary

The Associate Director, CMC Synthetic Chemistry – Small Molecule is a senior scientific individual contributor responsible for the hands‑on development, optimization, and scale‑up of synthetic routes for small molecule drug candidates. Reporting to the Executive Director, CMC Synthetic Chemistry, this individual plays a central role in advancing API process chemistry from early development through clinical manufacturing, ensuring that synthetic routes are robust, scalable, safe, and regulatory‑ready. This role carries no direct reports but serves as the primary technical owner for assigned programs and is the key scientific interface with CDMO process chemistry partners. It requires deep expertise in organic and process chemistry, direct experience with CDMO technical management, and the ability to operate with scientific independence and collaborative agility in a pre‑commercial biotech environment.

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

• Lead the design, evaluation, and optimization of synthetic routes for small molecule APIs, applying mechanistic understanding and process chemistry principles to develop robust, scalable, and cost‑efficient manufacturing processes.
• Execute and oversee process development campaigns including reaction optimization, solvent selection, intermediate characterization, and process safety assessments from lab scale through CDMO kilo‑lab and pilot plant operations.
• Serve as the primary technical interface with CDMO process chemistry teams, providing day‑to‑day scientific oversight of API synthesis campaigns, reviewing batch records, and driving rapid resolution of process deviations and out‑of‑specification events.
• Author and contribute to drug substance sections of regulatory filings (IND, IMPD, NDA) including synthetic route descriptions, process development summaries, control strategy justifications, and raw material specifications.
• Design and execute Design of Experiments (DoE) studies to define process parameters, establish proven acceptable ranges, and support the development of a robust process control strategy in alignment with QbD principles.
• Conduct and document process hazard evaluations, reaction safety assessments, and scale‑up risk analyses in collaboration with process safety and engineering functions at CDMO partners.
• Oversee the sourcing, qualification, and quality assessment of starting materials, reagents, and key intermediates, partnering with Quality and Regulatory Affairs on supplier qualification and control strategy.
• Contribute to intellectual property strategy for synthetic routes and manufacturing processes by working closely with IP/Legal to identify patentable innovations.
• Operate as a self‑directed scientific contributor — managing API route scouting, process development and optimization studies and providing technical oversight of external manufacturing campaigns independently while coordinating effectively with cross‑functional and external partners to advance program deliverables on schedule.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Ph.D. in Organic Chemistry preferred; or equivalent industry experience in pharmaceutical process development.
• 7+ years of API development and process chemistry and experience in pharmaceutical and/or biotechnology industry
• Demonstrated track record of serving as the primary scientific lead on synthetic chemistry programs from development through GMP manufacture.
• Deep expertise in synthetic route design and optimization for complex small molecule APIs, including multi‑step synthesis, chiral chemistry, and heterocyclic chemistry.
• Hands‑on experience executing and overseeing API process development campaigns at CDMO sites, including batch record review, technical troubleshooting, and scale‑up support.
• Proficiency with cGMP expectations for drug substance manufacture.
• Experience authoring drug substance sections of INDs, IMPDs, or NDA filings and responding to associated agency questions.
• 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 $199,750 - $258,000 USD

Benefits

• 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