Associate Director, Analytical Development Permanent

We’re looking for a candidate to fill this position in an exciting company.

• at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards.
• Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs.
• Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.
• Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
• Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards.
• Implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.

• Ph.D. or M.S. in chemistry, biology, biochemistry, or related technical discipline
• Minimum of 8 years of biopharmaceutical analytical experience with recombinant biologic modalities and exposure to all stages of biologics drug development
• Significant experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment and process characterization for therapeutic proteins/mAbs is highly desirable
• Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization is expected, as well as a thorough knowledge of structure-function relationship of therapeutic proteins
• Approximately 10-15% domestic and international travel is anticipated