Director, Biomanufacturing

Job ID: 3001234

About the role

We are seeking a visionary Director of Biomanufacturing to lead our state-of-the-art biologics production facility. In this pivotal role, you will oversee all aspects of biomanufacturing operations, ensuring compliance with cGMP standards while driving continuous improvement in productivity, quality, and cost efficiency. This position reports directly to the Vice President of Operations and plays a key role in advancing our pipeline of life-saving therapies.

Responsibilities

• Provide strategic leadership for all biomanufacturing activities, including upstream/downstream processing, fill-finish, and lyophilization.
• Oversee a team of 80+ personnel across production, process development, quality control, and facilities maintenance.
• Ensure strict adherence to FDA, EMA, and ICH guidelines for biologics manufacturing.
• Drive technology transfer of new processes from R&D to commercial-scale production.
• Lead capacity planning and facility expansion initiatives to support pipeline growth.
• Implement lean manufacturing principles and digital transformation initiatives (e.g., PAT, MES, AI-driven analytics).
• Collaborate with cross-functional teams to resolve manufacturing deviations and implement CAPAs.
• Manage budgets exceeding $50M annually, optimizing resource allocation and cost structures.
• Foster a culture of operational excellence, safety, and compliance across the manufacturing organization.

Requirements

• Bachelor’s degree in Biochemical Engineering, Biotechnology, or related field; advanced degree preferred.
• 12+ years of progressive experience in biopharmaceutical manufacturing, with 5+ years in a leadership role.
• Proven track record managing large-scale biologics production (mammalian cell culture, microbial fermentation, or gene therapy).
• Deep expertise in cGMP regulations, aseptic processing, and quality-by-design principles.
• Experience with single-use technologies, automation, and Industry 4.0 initiatives.
• Strong business acumen with experience in budget management and strategic planning.
• Exceptional leadership skills with a focus on talent development and team building.

Skills

• Technical: Bioreactor operations, chromatography, filtration, fill-finish, lyophilization, PAT tools.
• Regulatory: FDA/EMA inspections, BLA/MAA filings, risk management (ICH Q9).
• Systems: MES (e.g., Werum PAS-X), LIMS, ERP (SAP), data analytics (e.g., Tableau, Spotfire).
• Soft Skills: Change management, stakeholder communication, conflict resolution.

Benefits

• Competitive base salary with annual performance bonus (target 20-30%).
• Comprehensive health benefits (medical, dental, vision) with 90% premium coverage.
• 401(k) matching (up to 5% of salary) and employee stock purchase plan (15% discount).
• 3 weeks paid vacation, 10 paid holidays, and 12 sick days annually.
• Tuition reimbursement ($10,000/year) and professional development budget ($3,000/year).
• On-site amenities: fitness center, cafeteria, childcare subsidy, and commuter benefits.

Pay

$180,000 – $220,000 base salary, plus annual bonus and equity awards.

Schedule

• Full-time, exempt position.
• Core hours: 8:00 AM – 5:00 PM, Monday–Friday, with flexibility for off-hours support during critical operations.
• On-call rotation (1 week per quarter) for manufacturing emergencies.