A growing biopharmaceutical company is seeking an Associate Director, Drug Product Manufacturing to oversee drug product manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs). This role will focus on drug product development, optimization, and troubleshooting for biological process development and manufacturing to support clinical programs for antibody therapeutics.
We are in need of someone that has:
- Strong experience directly in drug product (particularly with antibodies or other recombinant protein products)
- Process Development & Validation: experience in Process Validation/PPQ study requirements for liquid/lyophilization vial filling
Key Responsibilities
- Provide technical oversight and guidance to CDMO teams, fostering strong partnerships to ensure effective manufacturing of investigational products.
- Evaluate process parameters, specifications, and develop rationales for specifications.
- Author/review protocols, reports, and technical transfer documents.
- Analyze batch data for trends and assess Out of Specification (OOS) or Out of Trend (OOT) results.
- Review batch records to support batch release and campaign reports.
- Conduct and/or review technical risk assessments.
- Contribute to the selection and evaluation of CDMOs.
- Support regulatory filings by authoring and reviewing relevant reports.
- Translate technical CMC manufacturing issues into actionable insights for cross-functional teams.
- Represent CMC Manufacturing in cross-functional process teams.
Qualifications
- Bachelor's, Master's, or Ph.D. in Chemical Engineering, Bioengineering, Biology, Protein Chemistry, Biochemistry, or related fields.
- At least 6+ years of experience in the biopharmaceutical industry.
- Proven success in supplier/vendor management within a cGMP-regulated environment.
- Hands-on experience with unit operations, including technology transfer to cGMP manufacturing and validation of drug product filling lines and processes.
- Working knowledge of FDA and international cGMP regulations and guidelines.
- Experience supporting regulatory submissions.
- Strong prioritization, problem-solving, and organizational skills.
- Proven ability to collaborate across cross-functional teams and work effectively with global CDMOs.
- Excellent verbal and written communication skills with the ability to adapt communication approaches as needed.
- Demonstrated project management experience and attention to detail.
- Ability to adapt to a fast-paced environment with competing priorities.
- Proficiency in Microsoft Office and familiarity with data processing and analysis tools.
- Willingness to travel for Process Improvement Projects (PIP) and onsite meetings.
This is an exciting opportunity for a highly motivated professional with technical expertise and leadership skills to make an impact in a dynamic and fast-paced environment.
