Beeline Medicines
Biotechnology
Director,CMCAnalyticalDevelopment–Biologics
Neural analysis suggests this role is
optimal for Director candidates.
“Director, CMC Analytical Development – Biologics at Beeline Medicines. Skills: Analytical Development, Biologics, Regulatory Affairs, CMC. Drive development of analytical methods. Drive qualification of analytical methods”
Industry & Context.
Deviation investigation; OOS investigation
What They're Looking For.
Must Have
10+ years analytical development experience, Deep technical expertise in biologics analytical methods, Comprehensive knowledge of ICH Q2(R1), Q6B, Q5B/C/E, Experience authoring analytical sections of regulatory submissions, Hands-on experience managing method transfer, Experience designing and executing stability programs, Proven track record operating in pre-commercial environments, Experience managing cross-functional stakeholder relationships, Exceptional ability to translate complex science, Experienced and confident in regulatory agency interactions
Nice to Have
PhD in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or related, Equivalent work experience
What You'll Do.
Drive development of analytical methods
Drive qualification of analytical methods
Drive validation of analytical methods
Ensure analytical readiness for submissions
Partner with CMC-Drug Substance
Partner with CMC-Drug Product
Partner with Regulatory Affairs
Partner with external CDMOs
Partner with contract analytical labs
Embed robust analytical science
Support internal audits
Support regulatory inspections
Collaborate on platform methods
Collaborate on cross-modality initiatives
Contribute biologics expertise
Mentor analytical scientists
Develop analytical scientists
Contribute to onboarding
Contribute to capability planning
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional teams; External partners; Senior level relationships
Communication Scope
Written communication; Verbal communication; Executive presentations; Regulatory documents; Scientific reports
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 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 closely 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 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
Applying for this Director, CMC Analytical Development – Biologics role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Beeline Medicines?
Real rants from real employees. Read before you apply.