Director, CMC Analytical Development – Biologics

Beeline Medicines • Boston, MA

2d • Hybrid

About The Position

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.

Requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline; and/or equivalent work experience.
• 10+ years of analytical development experience in biopharmaceuticals in the pharmaceutical and/or biotechnology industry
• Deep technical expertise in biologics analytical methods including SEC, CE-SDS, IEF/icIEF, peptide mapping, glycan analysis, SPR/biosensor assays, potency/bioassay platforms, and structural characterization.
• Comprehensive knowledge of ICH Q2(R1), Q6B, Q5B/C/E, and relevant USP/EP biologics chapters; experience authoring analytical sections of regulatory submissions (IND/IMPD and BLA) and responding to agency information requests.
• Hands-on experience managing method transfer and analytical oversight at CDMOs and contract testing laboratories, including deviation/OOS investigation management and change control.
• Experience designing and executing forced degradation, photostability, and ICH-compliant long-term stability programs for protein-based therapeutics.
• Proven track record of operating effectively in pre-commercial, resource-constrained environments — balancing strategic vision with hands-on execution and infrastructure building.
• Experience managing cross-functional stakeholder relationships at the senior level, with the ability to influence without authority and align diverse teams around shared program goals.
• Exceptional ability to translate complex CMC biologics science into clear, decision-ready narratives for executive leadership, cross-functional partners, and non-technical stakeholders.
• Experienced and confident in regulatory agency interactions, including FDA meetings and written responses, with the ability to represent the organization's scientific position with precision and credibility.
• Strong written and verbal communication skills, with a track record of authoring high-quality regulatory documents, scientific reports, and executive-level presentations.
• Collaborative communication style with the ability to establish trust quickly across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.

Responsibilities

• Lead the development, qualification, and validation of analytical methods for biologics drug substance and drug product, including primary structure, higher-order structure, potency, purity, and product-related impurities.
• Serve as the primary scientific authority on biologics characterization strategy, overseeing physicochemical and biological characterization packages in support of IND, BLA, and comparability assessments.
• Design and manage ICH Q5C-compliant stability programs for biologics candidates, including forced degradation studies, real-time/accelerated conditions, and shelf-life determination.
• Author and review analytical sections of regulatory filings for biologics programs (IND, BLA, briefing documents), and lead or support FDA/EMA interactions on analytical and characterization topics.
• Manage method transfer to and technical oversight of contract analytical laboratories and CDMO sites performing biologics release and characterization testing.
• Partner with Process Development and Manufacturing to define in-process controls, release specifications, and comparability strategies across process changes and scale-up events.
• Evaluate and implement advanced analytical technologies for biologics characterization, including SEC-MALS, AUC, HDX-MS, peptide mapping, glycan profiling, CE-SDS, and biosensor platforms.
• Establish and maintain data integrity practices within the analytical function in alignment with GMP expectations; support internal audits and regulatory inspections from an analytical perspective.
• Collaborate with the Analytical Development team on platform methods and cross-modality initiatives, contributing biologics-specific expertise to shared analytical infrastructure.
• Mentor and develop analytical scientists within the biologics team; contribute to hiring, onboarding, and capability planning as the biologics pipeline expands.
• Perform other duties and responsibilities as assigned

Benefits

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
• Flexible work arrangements / hybrid schedule
• Health Savings Account (HSA)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree