Beeline Medicines
Biotechnology
AssociateDirector,CMCAnalyticalDevelopment–SmallMolecule
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“Associate Director, CMC Analytical Development – Small Molecule at Beeline Medicines. Skills: Method development, Method validation, Regulatory filings. Develop analytical methods. Qualify analytical methods”
Industry & Context.
Deviation resolution; Out-of-specification investigation
What They're Looking For.
Must Have
7+ years pharmaceutical analytical development experience, Small molecule focus, Method development and validation experience, Author analytical sections of filings, Respond to regulatory information requests, Manage method transfer to contract labs, Manage out-of-specification investigations, Set scientific direction, Prioritize workstreams, Drive program accountability, Manage external partner relationships, Technical oversight of partners, Work order management, Change control management, Deviation resolution management, Performance monitoring at working level
Nice to Have
Experience in pre-commercial biotech environment
What You'll Do.
Develop analytical methods
Qualify analytical methods
Validate analytical methods
Support small molecule drug substance programs
Support small molecule drug product programs
Serve as technical owner for analytical activities
Oversee method development
Oversee characterization
Author analytical sections of regulatory submissions
Serve as scientific interface with contract labs
Serve as scientific interface with CDMOs
Manage analytical workstreams independently
Manage method transfer
Develop transfer protocols
Oversee method validation
Manage out-of-specification investigations
Set scientific direction for CMC programs
Prioritize workstreams for CMC programs
Drive program accountability for CMC programs
Manage external partner relationships
Provide technical oversight to partners
Manage partner work orders
Manage partner change control
Resolve partner deviations
Monitor partner performance
How You'll Work.
Team & Collaboration
Senior leadership; Cross-functional partners; CMC functions; Clinical Development; Regulatory Affairs; Quality; External partners; CDMOs; Contract laboratories
Communication Scope
Present scientific data; Present development recommendations; Present program updates; Written communication; Verbal communication
Process & Methodology
Workstream prioritization, Program accountability
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 Analytical Development – Small Molecule is a senior analytical scientist and individual contributor responsible for the development, qualification, and validation of analytical methods supporting small molecule drug substance and drug product programs. Reporting to the Executive Director, CMC Analytical Development, this individual serves as the primary technical owner for analytical activities on assigned programs, covering method development, characterization, stability, and analytical sections of regulatory submissions. This role carries no direct reports but is the key scientific interface with contract analytical laboratories and CDMO analytical teams. It requires deep expertise in small molecule analytical development and testing, a knowledge of GMP laboratory practices, and the ability to manage analytical workstreams independently in a pre-commercial, fast-moving biotech environment. Work Arrangement or equivalent industry experience in pharmaceutical analytical development. 7+ years of pharmaceutical analytical development experience focused on small molecules in pharmaceutical or biotechnology
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