Senior Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

9d • $110,800 - $151,000

About The Position

This position will serve as an analytical subject matter expert (SME) to support Antibody Biologics CMC development. The role involves developing, establishing, qualifying, and transferring analytical methods used to monitor the critical product quality of Antibody Biologics drug substance and drug product. The scientist will contribute to the development and implementation of analytical development strategies and workflows, ensuring compliance with cGMP, safety, and regulatory requirements. Responsibilities include the analysis and evaluation of process intermediates, drug substance, and drug product at all stages of the development process.

Requirements

• BS/BA degree in chemistry or closely related field and 5+ years (7+ years preferred) of pharmaceutical industry experience, focusing on separation method development OR MS/MA degree in chemistry or closely related field preferred and 3+ years (5+ years preferred) of pharmaceutical industry experience noted above OR PhD in chemistry or closely related field (2+ years preferred) of pharmaceutical industry experience
• Expert knowledge and understanding of analytical chemistry and a thorough understanding of antibody bioprocess including cell line development, upstream development, downstream development, and formulation development
• Proficient in characterization of antibody modalities using various analytical technologies with a focus on separation technologies, including but not limited to liquid chromatography (SEC, HILIC, RP, HIC, AEX, CEX), capillary electrophoresis (Maurice, PA800+, Labchip GX/GXII, etc.), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry.
• Hands on experience in homodimer/heterodimer separation method development for bi-specific/tri-specific antibodies are preferred.
• Method development, qualification, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Excellent laboratory and productivity skills
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent problem solving and critical thinking skills

Nice To Haves

• 7+ years of pharmaceutical industry experience, focusing on separation method development (if BS/BA)
• 5+ years of pharmaceutical industry experience (if MS/MA)
• 2+ years of pharmaceutical industry experience (if PhD)
• Hands on experience in homodimer/heterodimer separation method development for bi-specific/tri-specific antibodies

Responsibilities

• Lead analytical method development, qualification/validation and transfer for the characterization of Antibody Biologics utilizing various analytical separation techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF
• Expand internal analytical capabilities to support method development/qualification/validation/transfer activities as well as process development activities such as cell line development, upstream/downstream development, formulation development
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC analytical development strategies
• Ensure laboratory safety practices
• Other duties as assigned

Benefits

• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior