Director, CMC Analytical Development – Biologics

Overview

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. Led by an established executive team and backed by world-class life science investors, the company aims to bring scientific rigor and operational excellence to help patients with immune‑mediated diseases live life fully.

Job Summary

The Director, CMC Analytical Development – Biologics is a senior scientific leader responsible for driving the development, qualification, and validation of analytical methods supporting biologics drug substance and drug product programs. Reporting to the Executive Director, CMC Analytical Development, this individual is the primary technical authority on biologics characterization and analytical control strategy, ensuring analytical readiness across IND, Phase 1–3, and BLA submission milestones. This role partners with CMC-Drug Substance, CMC-Drug Product, Quality, Regulatory Affairs, and external CDMOs and contract analytical labs to embed robust analytical science into the biologics development pipeline.

Work Arrangement & Location

Hybrid work schedule with a minimum of two on-site days per week — currently 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 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.

Qualifications

• Education: 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 ability to operate 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 and non-technical stakeholders.
• Regulatory agency interaction experience, 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 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.

Salary Range

The expected annual salary range for this position is listed below. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

Salary Range: $211,000 - $229,800 USD

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)
• Benefits are subject to eligibility requirements and plan terms. Additional details 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 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. Privacy practices can be found at Privacy Policy – Beeline Medicines.

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