Associate Director, Technical Operations, Biologics Drug Substance Manufacturing

Remote – US based candidates only, no visa sponsorship available.

About the role

This role will lead operational priorities where safety, quality, compliance, and execution discipline are central to success. You will collaborate with field leadership, support functions, and cross-functional stakeholders to improve accountability, service delivery, and operational consistency. The position offers the opportunity to influence operational scale, customer outcomes, and organizational performance within a life sciences environment.

Responsibilities

• Provide technical oversight for drug substance manufacturing at CDMOs
• Review and approve manufacturing documents such as batch records and protocols
• Serve as technical resource for GMP quality systems
• Monitor process performance and recommend improvements
• Support tech transfer and process scale-up at CDMOs
• Partner with Regulatory Affairs on CMC documentation for IND and BLA
• Author technical reports on manufacturing subjects

Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred
• 8+ years of experience in biologics manufacturing and late-stage drug development
• Strong expertise in microbial fermentation and downstream processing for biologics
• Direct experience with QbD and PPQ activities
• Broad knowledge of US and EU cGMP regulations and FDA guidance
• Experience with external CDMOs and technical issue resolution
• Excellent technical writing and communication skills

Pay

$150,000 – $195,000 annually

Benefits

• Premium health insurance for employees and dependents
• Wellness and employee support programs
• Life insurance and disability coverage
• Retirement plans with employer match
• Generous paid time off policy