Director, External CDMO Management (Analytical)
- Location: Middlesex County, NJ
- Type: Direct Hire
- Job #38828
Our client – a leading privately-owned biopharmaceutical company – is seeking an Analytical Development (CDMO) Director.
In this role, you will lead and manage external manufacturing Analytical Development. You will be responsible for quality relationships with CDMO partners and vendors to ensure analytical development activities are qualified and using GMP procedures.
- Serves as a Subject Matter Expert (SME) for all external method development, method validation activities as well as providing guidance and direction for strategy and planning
- Leads analytical development activities for externally developed brand and generic products, including drug substance and drug product, at approved CDMOs
- Guides external method development and validation strategies to ensure all current scientific and regulatory standards are met
- Reviews and approves all related methods, protocols, reports, specifications, change controls, etc. generated by CDMOs
- Critically reviews and trends data generated by CDMOs
- Reviews and approves all investigations and Corrective Action Preventive Action (CAPAs), related to analytical methods and results
- Manages CDMO chemical development activities including, but not limited to: impurity profiles, reference standards, structure elucidation, etc. as needed
- Authors, reviews and approves analytical related regulatory submission documents and modules (both drug substance and drug product) of externally developed projects at CDMOs
- Conducts due diligence pertinent to analytical for products/assets being considered by acquisition or in-licensing
- Masters degree in science field and minimum 10 years related pharmaceutical or biotechnology laboratory experience in positions of increasing technical and leadership responsibility OR Ph.D. degree in science field and minimum 8 years related pharmaceutical or biotechnology laboratory experience in positions of increasing technical and leadership responsibility.
- Proven success in overseeing and guiding CDMOs and other external partners on analytical development strategies and execution for brand and generic products
- Proven success in leading analytical development, including method development and validation, with high scientific standard
- Current working knowledge and experience with physical characterization, thermal, spectroscopic, and chromatographic techniques and concepts
- Working knowledge of FDA, cGMPs, Drug Enforcement Agency (DEA) and Occupational Safety and Health Administration (OSHA) regulations and guidance
- Excellent ability to trouble-shoot, prioritize and critically review technical document