Beeline Medicines
Biotechnology
AssociateDirector,CMCProductDevelopment–SmallMolecule
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“Associate Director, CMC Product Development – Small Molecule at Beeline Medicines. Skills: Formulation development, CDMO management, Regulatory submissions. Lead formulation development activities. Oversee drug product process development”
Industry & Context.
Deviation resolution
What They're Looking For.
Must Have
7+ years pharmaceutical drug product development, Small molecule drug development experience, Experience authoring drug product sections of INDs, IMPDs, and NDA filings, Experience managing external partner relationships including CDMOs, Hands-on experience in technical oversight, Work order management experience, Change control experience, Deviation resolution experience, Performance monitoring experience
Nice to Have
Ph. D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or closely related discipline, Equivalent industry experience in pharmaceutical analytical development, Demonstrated track record of serving as primary scientific lead, Deep expertise in solid oral dosage form development, Experience contributing to FDA or EMA responses, Proven ability to operate as high-impact individual contributor, Experience executing against multiple program deliverables simultaneously, Experience operating with scientific independence, Experience contributing to build-out of functional infrastructure and processes
What You'll Do.
Lead formulation development activities
Oversee drug product process development
Oversee drug product scale-up
Serve as primary technical interface with CDMOs
Provide day-to-day scientific oversight
Author drug product sections of regulatory submissions
Contribute to regulatory submissions
Integrate Quality by Design principles
Integrate Design of Experiments
Establish critical quality attributes
Establish critical process parameters
Oversee drug product stability programs
Support packaging development
Support container-closure system selection
Contribute to clinical supply planning
Provide manufacturing timelines
Provide batch size projections
Provide drug product release schedules
Evaluate drug delivery technology options
Provide formulation feasibility assessments
Provide manufacturability input
Manage formulation study plans
Manage CDMO deliverable timelines
Manage CMC documentation
Keep teams aligned on program status
Keep leadership aligned on program status
Keep teams aligned on risks
Keep leadership aligned on risks
Keep teams aligned on decisions
Keep leadership aligned on decisions
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional CMC teams; Cross-functional teams; Senior leadership; External partner relationships
Communication Scope
Written communication; Verbal communication; Present scientific data; Present development recommendations; Present program updates
Process & Methodology
CDMO deliverable timelines
Full 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 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 - 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 b
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