Bioassay Scientist/Sr. Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

2d

About The Position

This role will serve as the analytical potency subject matter expert (SME) supporting CMC development for biologics, including antibodies and bioconjugates. The incumbent will be responsible for developing, qualifying/validating, and managing potency assays used to assess and monitor key quality attributes for both drug substance and drug product. This includes contributing to bioassay strategy, method execution, and regulatory-compliant data analysis across all stages of the drug development lifecycle. Work will be performed in compliance with cGMP, safety, and applicable regulatory requirements.

Requirements

• BS/BA degree in Biology or closely related field and 5+ years of pharmaceutical industry experience in an R D/QC setting, including conducting bioassay analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR MS/MA degree in Biology or closely related field and 3+ years of similar experience noted above OR PhD in Biology or closely related field and some relevant experience; may include post-doc experience
• Strong knowledge of analytical bioassays and antibody-based drug development preferred
• Hands-on experience with antibody and bio-conjugate modalities, with emphasis on analytical development and potency methods
• Proficient in bioassay technologies, including but not limited to: cell-based assays (e.g., proliferation, inhibition, cytotoxicity, reporter/luciferase), immunoassays (e.g., ELISA, TR-FRET), binding assays (e.g., SPR) and molecular biology assays (e.g., qPCR)
• 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

Responsibilities

• Lead potency methods development, and qualification/validation activities to support characterization of antibody and antibody conjugate modalities utilizing various bioassays including but not limited to cell-based assays, ELISA, TR-FRET, qPCR, and SPR
• Design, execute, analyze, and interpret bioassay data for process intermediates, drug substance, and drug product across all development stages
• Represent Analytical Development as potency SME on CMC cross-functional teams and maintain accountability for analytical deliverables
• Support analytical method transfer, manufacturing support activities, and technical interactions with external vendors and contract laboratories Lab Personnel and ensure laboratory safety practices
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
• Other duties as assigned

Benefits

• 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 in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees