Beeline Medicines
Biotechnology
Director,CMCProductDevelopment–Biologics
“Director, CMC Product Development – Biologics at Beeline Medicines. Skills: CMC Product Development, Biologics Drug Product, Formulation Development, Process Development. Lead end-to-end CMC development. Drive drug product development strategy”
Industry & Context.
What They're Looking For.
Must Have
10+ years CMC biologics experience, Expertise in drug product formulation, Expertise in fill-finish process development, Experience authoring BLA drug product sections, Experience managing CDMO relationships, Experience with lyophilized formulation, Experience with liquid formulation, Experience with parenteral biologics, Experience with primary packaging compatibility, Experience with extractables/leachable considerations, Working knowledge of biologics drug substance processes, Track record operating in pre-commercial environments, Experience managing cross-functional stakeholder relationships
Nice to Have
Experience with biologics drug substance processes sufficient to partner with Drug Substance teams
What You'll Do.
Lead end-to-end CMC development
Drive drug product development strategy
Ensure integrated delivery of CMC activities
Provide technical oversight of fill-finish operations
Manage process scale-up
Manage process qualification
Manage commercial readiness
Partner with Drug Substance teams
Balance strategic vision with execution
Translate complex science into narratives
Author regulatory documents
Author scientific reports
Author executive presentations
How You'll Work.
Team & Collaboration
Cross-functional teams; External CDMOs; Senior level relationships; Diverse teams; Executive leadership; Non-technical stakeholders; Research teams; Clinical teams; Regulatory teams; Quality teams; External partners; Matrixed organization
Communication Scope
Written communication; Verbal communication; Executive presentations; Regulatory documents; Scientific reports
Applying for this Director, CMC Product 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.