Associate Director, cGMP Manufacturing

Requirements

• MS or PhD in Chemistry, Biochemistry, Chemical Engineering, or related discipline; or BS with 8+ years of cGMP peptide manufacturing experience
• 6+ years of cGMP manufacturing experience in pharmaceutical, biopharmaceutical, or peptide manufacturing
• 5+ years of hands-on experience with solid-phase peptide synthesis (SPPS), prep HPLC purification, and lyophilization unit operations
• 3+ years in a leadership role managing manufacturing operations or production teams
• Expertise in cGMP batch execution, master batch record authoring, and campaign management
• Strong understanding of FDA cGMP expectations for manufacturing operations, data integrity (21 CFR Part 11), and batch record documentation
• Experience supporting process validation, PPQ campaigns, and tech transfer of new peptide products into GMP manufacturing
• Demonstrated manufacturing management skills including budget oversight, capital project management, vendor management, and staffing
• Strong problem-solving and investigative skills; ability to troubleshoot process and equipment issues in real time on the manufacturing floor
• Excellent communication skills; ability to communicate manufacturing status, deviations, and risks clearly to quality, operations, and regulatory teams

Benefits

• Medical, dental, and vision insurance
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
• Disability insurance 50% standard employer paid
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities