Senior Jobs in Irvine ca

Senior Scientist, Analytical Development (Biologics)

About the role :

Looking for a SME in Analytical Development with in-depth knowledge of a wide range of biologic modalities, including but not limited to AAV, LLV, mAbs, bispecific antibodies, ADCs, and fusion proteins. This individual will play a key role in driving analytical strategies across the development lifecycle, from early discovery through late-stage development, and will be instrumental in supporting regulatory filings & the overall Analytical strategy.

Responsibilities :

• Serve as the scientific lead for the analytical characterization of biologic drug candidates, with a focus on AAV, LLV, mAbs, bispecifics, ADCs, and fusion proteins.
• Lead and oversee the design and execution of analytical strategies to support the development and characterization of biologics, ensuring they meet product quality, stability, and regulatory requirements.
• Provide analytical expertise to support early- and late-stage development, from preclinical through Phase 3 clinical trials.
• Contribute to the preparation and review of CMC sections for regulatory submissions (e.g., IND, BLA).
• Collaborate cross-functionally with teams in biologics discovery, process development, formulation, and quality control to ensure alignment of analytical testing with overall product development strategies.
• Develop and implement novel analytical methodologies and tools to address the unique challenges presented by complex biologics, ensuring robustness, accuracy, and reproducibility.
• Mentor and train junior scientists and other team members, fostering a collaborative, high-performance work environment.
• Stay current with industry trends, regulatory guidelines, and advances in analytical techniques relevant to biologics.

Qualifications :

Preferred Qualifications :