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.