Posted 27 days ago
Principal Scientist, Analytical Development & Formulation
San DiegoOn-siteFull-time
AI Summary
Leads analytical and formulation development for immuno-oncology and autoimmune therapeutics, managing method validation, stability studies, and CDMO activities while ensuring regulatory compliance.
About this role
We are seeking a highly skilled and motivated Principal Scientist to join our Analytical and Formulation Development team. The successful candidate will lead and oversee analytical and formulation development activities for our pipeline of therapeutic candidates in immuno-oncology and autoimmune disease. This role requires a deep understanding of analytical methodologies, formulation development of biologics, regulatory requirements, as well as experience managing analytical development and QC activities at CDMOs.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Responsible for the development and qualification/validation of analytical methods for drug substances and drug products at CDMOs.
- Design and execute formulation development studies to support preclinical and clinical programs.
- Oversee stability studies and ensure compliance with regulatory guidelines.
- Provide oversight of reference standard or reference material programs.
- Collaborate with cross-functional teams including Research, Quality, and Regulatory Affairs, to advance projects from early development through commercialization.
- Provide technical leadership and mentorship to junior scientists and research associates.
- Author and review technical reports and regulatory submissions.
- Conduct pre-formulation characterization and formulation studies to develop clinical formulations.
- Develop and implement protocols for analytical method qualification and formulation development.
- Ensure accurate documentation and reporting of laboratory activities and results.
- Support compatibility testing of clinical supplies.
- Troubleshoot and resolve technical issues related to laboratory experiments and equipment.
- Other duties as assigned or deemed necessary by management.
REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES
- Ph.D., M.S., or B.S. in analytical chemistry, cell and/or molecular biology, engineering, or relevant discipline with a minimum of 4 years (Ph.D.), 8 years (M.S.) or 10 years (B.S.) of directly relevant industry experience, preferably with biologics.
- Extensive experience in analytical method development, validation, and troubleshooting.
- Proven track record in formulation development for protein therapeutics.
- Strong knowledge of regulatory requirements (FDA, Ph. Eur., ICH) and cGMP guidelines.
- Experience with advanced analytical techniques utilized in drug development for biologics.
- Familiarity with Quality by Design (QbD) principles and risk-based approaches.
- Must have experience in managing external CROs and CMOs.
- Demonstrates exceptional organizational skills, ensuring all tasks and projects are systematically managed.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
- Excellent problem-solving skills and the ability to work independently and collaboratively.
- Strong written and verbal communication skills.
Skills
Analytical Method DevelopmentAnalytical Method ValidationBiologicsCGMPCMO ManagementCRO ManagementFDA RegulationsFormulation DevelopmentICH GuidelinesPh. Eur.Pre-formulation CharacterizationQuality By Design (QbD)Reference Standard ManagementStability StudiesTroubleshooting Laboratory Equipment
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