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