Associate Director/Director Drug Product, CMC

About This Opportunity

Our talent team is representing a confidential biopharmaceutical client developing innovative therapies for patients with severe autoimmune diseases. We are seeking an experienced Associate Director/Director of Drug Product CMC to lead operational oversight of clinical external manufacturing for monoclonal antibodies and biotherapeutics. This role will drive scalable, robust processes from Drug Substance to Drug Product stage, with a focus on late-stage clinical development through commercial launch.

This is a remote opportunity open to candidates in Canada, France, Germany, Ireland, Switzerland, the United Kingdom, and the United States.

Responsibilities

• Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products in both liquid and lyophilized formats, including vial and prefilled syringe delivery systems
• Manage contract manufacturing organizations (CMOs/CDMOs) and oversee technology transfer of processes to external manufacturing partners
• Build robust manufacturing processes based on deep knowledge of vial/PFS fillers, isolators, RABS, sterilizers, and ancillary equipment functionality
• Ensure strict adherence to cGMP requirements and global health authority expectations (FDA, EMA) for aseptic controls
• Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations that minimize protein aggregation
• Execute risk assessments (FMEA) and define process control strategies using Quality by Design (QbD) principles
• Troubleshoot manufacturing issues, analyze data, and implement process improvements through drug product life cycle management
• Lead deviation investigations, CAPAs, and change controls
• Review CMC sections (Module 3) for regulatory submissions including INDs, IMPDs, and BLAs
• Serve as Subject Matter Expert during regulatory agency interactions, audits, and pre-approval inspections
• Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines

What We're Looking For

• Bachelor's degree with 12+ years or Master's degree with 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related scientific discipline
• 10+ years of drug product CMC support experience
• Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing
• Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs for commercialization
• Proven track record in people leadership with strong cross-functional communication and strategic problem-solving abilities
• Solid understanding of protein chemistry, including optimization of formulation and process parameters to overcome shear stress and aggregation
• Experience advancing combination product delivery systems from late-stage clinical development through process performance qualification and commercial launch
• Functional knowledge of analytical instruments preferred but not required
• Willingness to travel up to 5-10%

How We Work With You

Candidates should apply directly through Get A Job.ai. Our recruiting team will conduct an initial screening to assess fit and answer your questions about the role and our client. Qualified candidates will then be submitted to the client for consideration. Please do not attempt to contact the client directly, as all communication must flow through Get A Job.ai to ensure a professional and coordinated process.

Pay

Compensation details will be discussed during the screening process and are competitive with market rates for this level of experience and responsibility.

Equal Employment Opportunity: Get A Job.ai is committed to providing equal employment opportunities to all applicants regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. We value diversity and inclusion in our candidate pool and client partnerships.