Sr. Director/Director of Process Chemistry CMC
Not Disclosed•Full-TimeHybrid
location_onMayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
About the Organization
We are exclusively partnered with a well-funded, clinical-stage biopharmaceutical organization dedicated to advancing innovative small molecule therapeutics for serious diseases with high unmet needs. The company is currently building an integrated CMC (Chemistry, Manufacturing, and Controls) organization designed to support multiple clinical programs simultaneously.
About the Role
This position serves as a critical leadership hub within the technical strategy, external partnerships, and cross-functional execution of the CMC function. The Sr. Director/Director of Process Chemistry will lead drug substance development from late pre-clinical stages through clinical phases and beyond. You will play a pivotal role in guiding programs through key clinical and regulatory milestones, ensuring that chemical processes remain robust, scalable, cost-effective, and compliant with global regulatory expectations.
Hiring Process
Candidates selected for this role will engage in a structured interview process designed to assess technical depth, leadership capabilities, and cultural fit within our lean, fast-moving organization. The process typically includes an initial screening, technical deep-dives, and discussions with cross-functional stakeholders to ensure alignment with program timelines and strategic goals.
Equal Opportunity
We are an equal opportunity employer committed to building a diverse and inclusive team. We consider qualified applicants regardless of background, race, religion, gender, or other protected characteristics.
Work location
Work model: Hybrid
Mayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States
Boston, Massachusetts
Key Responsibilities
- check_circleOwn and drive drug substance development strategy including route scouting and process optimization
- check_circleLead external CDMO relationships overseeing process development and tech transfer
- check_circlePartner cross functionally with Formulation, Quality, Regulatory, and Clinical teams to align CMC strategy
- check_circleAuthor and review CMC sections of regulatory filings including INDs and amendments
- check_circleIdentify and mitigate technical, supply chain, and execution risks related to drug substance manufacturing
- check_circleSupport long term planning for late-stage development and commercialization readiness
- check_circleEnsure chemical processes are robust, scalable, cost effective, and compliant with global regulations
- check_circleBuild and mentor internal team members while contributing to CMC function governance
Requirements
- verifiedPhD or MS in Organic Chemistry, Chemical Engineering, or related discipline
- verified10+ years of experience in small molecule chemical development
- verifiedExperience advancing programs from pre-clinical to Phase 1-2 clinical development
- verifiedStrong background in external manufacturing and CDMO management
- verifiedSolid understanding of regulatory CMC expectations
Nice to Have
Experience with Phase 3 or commercial development.
Similar Job Opportunities
Skills, education and keywords
Skills: Organic Chemistry, Chemical Engineering, Small Molecule Therapeutics, Drug Substance Development, Process Optimization, Scale Up, Control Strategy Development, Process Development, Tech Transfer, Regulatory Filings.
Education: PhD in Organic Chemistry required.
Frequently asked questions about Sr. Director/Director of Process Chemistry CMC at EPM Scientific
What does a Sr. Director/Director of Process Chemistry CMC at EPM Scientific do?expand_more
Day-to-day, the Sr. Director/Director of Process Chemistry CMC at EPM Scientific will own and drive drug substance development strategy including route scouting and process optimization; lead external cdmo relationships overseeing process development and tech transfer; partner cross functionally with formulation, quality, regulatory, and clinical teams to align cmc strategy; and author and review cmc sections of regulatory filings including inds and amendments.
What are the requirements for this Sr. Director/Director of Process Chemistry CMC role?expand_more
EPM Scientific is looking for candidates who meet the following requirements: PhD or MS in Organic Chemistry, Chemical Engineering, or related discipline; 10+ years of experience in small molecule chemical development; Experience advancing programs from pre-clinical to Phase 1-2 clinical development; Strong background in external manufacturing and CDMO management; and Solid understanding of regulatory CMC expectations.
Where is the Sr. Director/Director of Process Chemistry CMC role at EPM Scientific located?expand_more
Sr. Director/Director of Process Chemistry CMC at EPM Scientific is based in Mayor's Walk, Beacon Hill, Boston, Suffolk County, Massachusetts, 02108, United States. This is a hybrid role.
Is this Sr. Director/Director of Process Chemistry CMC job remote, hybrid, or on-site?expand_more
EPM Scientific has listed this Sr. Director/Director of Process Chemistry CMC role as hybrid.
How much experience is required for this Sr. Director/Director of Process Chemistry CMC role?expand_more
Sr. Director/Director of Process Chemistry CMC at EPM Scientific typically requires 10+ years of relevant experience at the executive level.
What skills do you need for the Sr. Director/Director of Process Chemistry CMC role at EPM Scientific?expand_more
Key skills for Sr. Director/Director of Process Chemistry CMC at EPM Scientific include Organic Chemistry; Chemical Engineering; Small Molecule Therapeutics; Drug Substance Development; Process Optimization; Scale Up; Control Strategy Development; and Process Development.
What education is required for Sr. Director/Director of Process Chemistry CMC at EPM Scientific?expand_more
Educational requirements for this role: PhD in Organic Chemistry required.
What category does the Sr. Director/Director of Process Chemistry CMC role belong to?expand_more
Sr. Director/Director of Process Chemistry CMC at EPM Scientific is part of the scientific & qa job category on Recrutus.
About EPM Scientific
EPM Scientific operates within the professional services industry, specializing in recruitment for the life sciences sector. Headquartered in London, the firm was established in 2012 to address critical talent challenges facing organizations in this field. The company focuses on the intersection of emerging technologies, including 3D printing, gene editing, artificial intelligence, and big data, which are reshaping patient care and disease treatment across terrestrial and space environments.
The organization provides comprehensive staffing solutions to support the entire product lifecycle, ranging from initial research and development through to market launch and pharmacovigilance. Services include permanent placements, contract staffing, and multi-hire strategies designed to meet the diverse needs of life sciences clients. By connecting specialized professionals with industry leaders, EPM Scientific facilitates growth in a sector undergoing rapid technological transformation.
Potential partners seeking to discuss specific hiring requirements can request a consultation through the company's website. The firm maintains a dedicated approach to matching talent with roles that require expertise in advanced scientific disciplines and digital integration.
Browse more roles: All EPM Scientific jobs, scientific & qa jobs on Recrutus.