Head of Late-Stage Biologics & Commercial CMC

AbCellera; Vancouver; On-site; CAD 250,000 - 380,000; Full time

Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active Lifestyle Allowance

Job summary

AbCellera is seeking a creative, experienced leader to shape the CMC strategy for late-stage antibody programs and to build a high-performing MSAT team in Vancouver, Canada.

You will transition lead assets from clinical manufacturing to commercial readiness, drive cross-functional collaboration with Regulatory, QA, and Supply Chain, and oversee tech transfers with CDMOs to ensure timely regulatory submissions and robust processes.

Qualifications

• 18–20+ years in biopharmaceutical Process Development, MSAT, or CMC.
• 8+ years in leadership with mammalian cell culture and antibody therapeutics.
• Proven track record taking biologics from late-stage development through PPQ, BLA submission and commercialization.
• Extensive experience managing tech transfers with CDMOs and PIP oversight.
• Ability to build, lead and mentor high-performing teams in a fast-paced biotech environment.

Responsibilities

• Lead late-stage process development strategy for upstream cell culture and downstream purification, transitioning from Phase 2/3 manufacturing to commercial readiness.
• Oversee process characterization, PPQ studies and establish control strategies using QbD and DoE.
• Draft and review CMC sections for global regulatory submissions (BLA, MAA, NDS, IND amendments).
• Steer tech transfers, scale-ups, and troubleshooting across internal sites and CDMOs.
• Mentor and lead a high-performing MSAT team with a culture of scientific excellence.
• Coordinate with FDA/EMA on process validation and combination product regulations during milestone meetings.
• Support drug product characterization and integration of combination products with human factors engineering.
• Partner with QA, Regulatory Affairs, Supply Chain, Clinical and Commercial teams for strategy alignment.

Skills

Leadership

Biopharma

MSAT

CMC

Regulatory

Education

Post-secondary degree in Chemical/Biochemical Eng / Biotechnology / Biochemistry

Job description

AbCellera is seeking a creative, experienced leader to shape the CMC strategy for late-stage antibody programs and to build a high-performing MSAT team in Vancouver, Canada.

You will transition lead assets from clinical manufacturing to commercial readiness, drive cross-functional collaboration with Regulatory, QA, and Supply Chain, and oversee tech transfers with CDMOs to ensure timely regulatory submissions and robust processes.