Summary:
This clinical-stage Biotech is looking for a scientific leader with a strong background in Analytical Development (Biologics) to be part of a patient-focused, dedicated, passionate, and highly-talented team working on developing novel therapeutics as the next global leaders in scientific innovation.
Responsibilities:
- Lead development and qualification/validation of all analytical methods for monoclonal antibodies, fusion proteins and/or other biologics as per regulatory guidelines
- Establish robust analytical control strategy and life cycle management
- Transfer analytical methods into manufacturing sites
- Establish critical quality attributes (CQAs) using both risk assessment and experimental analysis. Develop a protocol for CQA assessment
- Establish drug substance (DS) and drug product (DP) specification with justification and get approval from the specification committee
- Lead, author protocols, and reports related to analytical development, qualification/validation, control strategy, life cycle management, and comparability assessment
- Author, review analytical sections of both drug substance and drug product for regulatory submissions in US, EU, and other emerging markets
- Support the development of biophysical characterization and author sections on higher order structure characterization for regulatory submission
Qualifications:
- Ph.D. in Analytical Chemistry/Biochemistry/Pharmaceutical Science, with 3 -5 years of industry experience in biologics development e.g. monoclonal antibody/fusion proteins, etc.; MS in Analytical Chemistry/Biochemistry/Pharmaceutical Science with 8 - 10 years of relevant industry experience
Additional Skills/Preferences:
- Clear understanding of science and in-depth experience for the development of common analytical and biophysical methods for biologics characterization including SEC, IEX, RP, HIC, SEC-MALS, SDS-PAGE, SDS-SEC, CE, IEF, UV-Vis; DSC; DLS; Polysorbate analysis etc.
- Clear understanding of regulatory requirements (USP, ICH, EMA etc.) for all analytical requirements
- Understanding of CMC aspects of drug development including related areas, upstream, downstream, and formulations
- Experience with regulatory submissions like BLA/MMA of biological modalities is highly desired
- Understanding of Mass Spectrometry for protein characterization is a plus
- Excellent writing skills and a strong team player in a collaborative cross functional team environment
