Manager II, Analytical Development - Antibodies

Manager II – Analytical Development (Antibodies)

Onsite in Cambridge, MA

Full-time

Stealth-mode biotech seeks a Manager II to join their Tech Ops / CMC team to impact the development of novel and next-generation therapeutics for an array of immunological disorders. Experience in antibody-based therapeutics required.

This is a newly created role to report to and support the VP, Technical Development & Operations. This role involve both hands-on bench work in the laboratory (~30-40%) and external management of CDMOs. For the right candidate, this role can expand beyond process development into analytical development, transfer and qualification of protein characterization, release and stability tests, supply chain, and more.

Key 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.

Minimum Qualifications

• 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 Qualifications

• 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.

This Company is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.