Aerial Talent · 3 weeks ago
Manager II, Analytical Development - Antibodies
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
5+ years expAerial Talent is a stealth-mode biotech company seeking a Manager II to join their Tech Ops / CMC team to impact the development of novel and next-generation therapeutics for immunological disorders. This role involves hands-on laboratory work and management of external CDMOs, focusing on process development and analytical development of antibody-based therapeutics.
Staffing & Recruiting
Hiring Manager
Annie Wasserman
Responsibilities
Design, develop, optimize and implement GMP manufacturing processes for complex protein therapeutics
Design and troubleshoot experiments related to upstream and downstream protein process development
Manage external development and GMP activities for Drug Substance (DS) and Drug Product (DP) at CDMOs
Provide CMC expertise on cross-functional project teams
Author and review technical documentation and sections of regulatory submissions
Qualification
Required
BS + 10 years', MS + 5 years', or PhD + 2 years' relevant industry experience
Bioprocess development of protein therapeutics, particularly antibody-based therapeutics
Upstream or downstream bioprocessing (e.g., cell line development, cell culture/media optimization, filtration, formulation, chromatography)
Preferred
Supporting tech transfer for a molecule from development to GMP manufacturing
Managing CDMOs for GMP drug substance and/or drug product manufacturing
Knowledge of GMP/ICH guidelines
Advanced protein characterization, biophysical and functional techniques (e.g., HPLC/UPLC, SEC, IEX, CE, LC/MS, ELISA/MSD, SPR/BLI, cell-based bioassays)
Supporting quality investigations (deviations, OOS)
Analytical development and/or quality control of protein therapeutics
Clinical supply chain and logistics for clinical trial material
Authoring sections of regulatory documents and other technical/quality documents
Company
Aerial Talent
Your one-stop shop to identify, attract and retain top talent while scaling your company to the next level.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Noelle Neufeld 🔎
Recruiter - Founder - Start-up Advisor
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