Senior Scientist

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: PhD in Analytical Chemistry, Biochemistry, Molecular Biology, or a related field, with a minimum of 4 years of experience in the biopharmaceutical industry. Extensive expertise in analytical techniques for biologic drug modalities, including AAV, LLV, mAbs, bispecifics, ADCs, and fusion proteins. Proven track record in taking biologic programs from early-stage development to late-stage, including supporting regulatory filings (IND, BLA). Strong knowledge of regulatory guidelines and industry standards (e.g., ICH, FDA, EMA) as they pertain to biologic products. Expertise in the application of techniques such as HPLC, SEC, CE-SDS, LC-MS, and bioassays for the characterization and quality control of biologic drugs. Hands-on experience with advanced technologies for structural characterization, stability studies, and formulation development of biologics. Strong problem-solving abilities, with a demonstrated ability to develop innovative solutions to complex technical challenges. Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment. Ability to mentor junior staff and lead scientific discussions and project teams. Knowledge of drug development processes and regulatory requirements for biologics is essential. Preferred Qualifications: Experience with gene therapies (AAV, LLV) and ADCs is highly desirable. Familiarity with cutting-edge techniques such as mass spectrometry, cryo-EM, and NMR is a plus. Prior experience in a leadership or supervisory role.