Associate Director, Technical Operations
About the role
For our client, we are seeking a Associate Director, Technical Operations to join the team of a leader in the Pharmaceuticals & Biotech space. This role will guide technical operations across clinical and commercial programs, with a strong focus on technology transfer, scale-up, validation, and external manufacturing support. The ideal candidate will bring deep CMC and cGMP expertise to help ensure high-quality execution, timely delivery, and regulatory readiness across drug development activities. In this position, you will partner closely with internal cross-functional teams and external manufacturing organizations to advance complex programs and support product lifecycle success. Location: Remote - US based candidates only, no visa sponsorship available
Responsibilities
- Lead technology transfer, scale-up, validation, and manufacturing for clinical and commercial products
- Manage the performance of external manufacturing partners to ensure they meet quality and timeline requirements
- Oversee chemical development of new drug candidates
- Review key regulatory documents and maintain compliance with cGMP requirements
- Provide technical oversight for contract manufacturing organizations on manufacturing processes and methods
- Mentor colleagues and cross-functional teams in CMC processes
- Author and edit CMC sections of regulatory submissions
Qualifications
- Bachelor's degree in Process or Chemical Engineering, Life Sciences, or a related discipline required
- 8 years of progressive cGMP-related CMC drug development or manufacturing experience required
- Demonstrated leadership experience in multiple CMC areas, particularly with small molecules, peptides, and biologics
- Manufacturing experience with oral solid dosage forms preferred
- Ability to adapt and implement new strategies in response to project changes
Benefits
- Premium health insurance offerings for employees and their dependents
- Wellness and employee support programs available
- Life insurance and disability coverage included
- Retirement plans with employer match
- Generous paid time off policies
Pay
Compensation: $150,000 – $195,000 annually