Principal Scientist, Analytical Development
Neurocrine Biosciences
9 days ago
Remote friendly (San Diego, CA)
United States
Operations
About The Role:
This position will serve as analytical development lead for multiple projects focused on monoclonal antibodies, including complex modalities such as bi-specific, tri-specific, and fusion proteins. Guide analytical activities for drug substance and drug product development from preclinical through commercial phase. Develop, establish, validate/qualify analytical methods to control in-process intermediates, drug substance, and drug products. Contribute to development and implementation of control strategies and ensure work complies with cGMP, safety, and regulatory requirements. Participate in analysis/evaluation of materials and products throughout development and monitor task/project completion.
Your Contributions (include, but are not limited to):
- Lead analytical method development and validation/qualification for monoclonal antibodies in cGMP compliance from preclinical through commercialization
- Represent Analytical Development on cross-functional teams; maintain accountability for analytical deliverables and CMC/manufacturing plan progress
- Direct laboratory work and/or lab personnel (company and external vendors)
- Provide expertise in separation techniques (e.g., SEC/RP/HILIC/IEX/HIC/Mixed Mode/2D-LC, CE-SDS, iCIEF)
- Support off-site analytical method transfers and manufacturing support; interact with external vendors
- Provide input into CMC regulatory documentation; leverage literature/ICH guidance to influence CMC strategies
- Contribute to policies/department strategies; build relationships; support team growth; present findings; other duties as assigned
Requirements:
- BS/BA in Analytical Chemistry (or related) + 12+ years analytical/pharmaceutical development, including method transfer experience OR MS/MA + 10+ years OR PhD + 4+ years (may include postdoc)
- Expert knowledge of analytical chemistry, separation sciences, bioprocess, and formulation development
- Extensive experience with monoclonal antibody analytical method development (release/stability)
- Strong interpersonal, oral/written communication, laboratory, and productivity skills
- Proficiency characterizing monoclonal antibodies (e.g., SEC/HPLC/UPLC, CE-SDS/iCIEF, electrophoresis, MS, ELISA, bioassays)
- Method development, validation, qualification, and transfer experience
- Comprehensive cGMP knowledge (drug substance and drug product)
- Cross-functional drug development understanding
- Knowledge of FDA/EMA/WHO/ICH regulatory requirements
This position will serve as analytical development lead for multiple projects focused on monoclonal antibodies, including complex modalities such as bi-specific, tri-specific, and fusion proteins. Guide analytical activities for drug substance and drug product development from preclinical through commercial phase. Develop, establish, validate/qualify analytical methods to control in-process intermediates, drug substance, and drug products. Contribute to development and implementation of control strategies and ensure work complies with cGMP, safety, and regulatory requirements. Participate in analysis/evaluation of materials and products throughout development and monitor task/project completion.
Your Contributions (include, but are not limited to):
- Lead analytical method development and validation/qualification for monoclonal antibodies in cGMP compliance from preclinical through commercialization
- Represent Analytical Development on cross-functional teams; maintain accountability for analytical deliverables and CMC/manufacturing plan progress
- Direct laboratory work and/or lab personnel (company and external vendors)
- Provide expertise in separation techniques (e.g., SEC/RP/HILIC/IEX/HIC/Mixed Mode/2D-LC, CE-SDS, iCIEF)
- Support off-site analytical method transfers and manufacturing support; interact with external vendors
- Provide input into CMC regulatory documentation; leverage literature/ICH guidance to influence CMC strategies
- Contribute to policies/department strategies; build relationships; support team growth; present findings; other duties as assigned
Requirements:
- BS/BA in Analytical Chemistry (or related) + 12+ years analytical/pharmaceutical development, including method transfer experience OR MS/MA + 10+ years OR PhD + 4+ years (may include postdoc)
- Expert knowledge of analytical chemistry, separation sciences, bioprocess, and formulation development
- Extensive experience with monoclonal antibody analytical method development (release/stability)
- Strong interpersonal, oral/written communication, laboratory, and productivity skills
- Proficiency characterizing monoclonal antibodies (e.g., SEC/HPLC/UPLC, CE-SDS/iCIEF, electrophoresis, MS, ELISA, bioassays)
- Method development, validation, qualification, and transfer experience
- Comprehensive cGMP knowledge (drug substance and drug product)
- Cross-functional drug development understanding
- Knowledge of FDA/EMA/WHO/ICH regulatory requirements