Contract Manufacturing Site Manager (Commercial Biologics and Drug Substance)

Description

On-site  Foster City, CA (Hybrid, 3days/ week)

Title: Contract Manufacturing Site Manager (Commercial Biologics and Drug Substance)

Core Mission

• Lead Client’s strategic partnerships with CMOs producing commercial biologics drug substance (mAbs, recombinant proteins, viral vectors), ensuring operational excellence, compliance, and supply chain resilience for high-value therapeutics.

Key Responsibilities

Strategic CMO Governance

• Serve as Client’s primary operational lead for high-volume CMOs, managing contracts, capacity planning, and performance metrics (OTIF, quality KPIs)
• Negotiate long-term agreements with CDMOs like AGC Biologics (mammalian/microbial) or Northway Biotech (gene therapy), ensuring scalability for commercial-stage products
• Drive cost optimization through lean manufacturing initiatives and dual-sourcing strategies

Technical Leadership

• Oversee large-scale tech transfers (2000L+ bioreactors, perfusion processes) and PPQ execution at CMOs, leveraging platforms like AGC’s CMC Jumpstart™ for viral vectors
• Resolve complex deviations (e.g., low titer, purification challenges) using PAT and real-time analytics
• Champion continuous manufacturing and single-use technologies to enhance flexibility

Compliance & Regulatory Oversight

• Ensure CMOs adhere to FDA/EMA/PMDA standards (ICH Q7, Annex 1), supporting PAIs and addressing 483s/CAPAs
• Review CMC sections for BLAs/MAAs and lead responses to health authority queries

Supply Chain Risk Mitigation

• Develop business continuity plans with CMOs like Dr. Reddy’s (12M vial capacity) to mitigate disruptions
• Partner with internal teams to balance capacity across Clients network (e.g., Oceanside facility)

 Industry Engagement

• Represent Client at conferences (e.g., CDMO Live 2025, BIO 2025) to evaluate emerging CDMO capabilities

Qualifications

Required:

• Education: BS/MS in Bioengineering or related field; PhD preferred.

Experience:

• 15+ years in commercial biologics and drug substance manufacturing, including 8+ years managing CMOs for commercial-stage products
• Expertise in upstream (cell culture intensification) and downstream (chromatography, TFF)
• Proven track record in tech transfers, process validation (PPQ), and lifecycle management
• Regulatory: Direct experience with FDA/EMA inspections and submissions

Preferred:

• Knowledge of viral vectors (AAV, LVV) or cell therapies
• Certifications: PMP, Lean Six Sigma