Senior Scientist, Analytical Development (Large Molecule)

Neurocrine Biosciences • San Diego, CA

1d • $130,800 - $179,000

About The Position

This position will serve as an analytical lead with a focus on peptides and bioconjugates, supporting drug substance and drug product development from preclinical through commercialization. The successful candidate will develop, establish, qualify/validate, and transfer analytical methods used to characterize and control raw materials, in-process materials, intermediates, drug substance, and drug product. The individual will independently conduct laboratory studies for the characterization of drug candidates, support formulation and process development, and contribute to CMC development and regulatory activities. Work will be conducted in alignment with cGMP principles, safety requirements, and applicable regulatory expectations.

Requirements

• BS/BA in Analytical Chemistry/Cell & Molecular Biology or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer and validation in Analytical Chemistry; OR MS/MA in Analytical Chemistry or related discipline and 10+ years of experience; OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
• Demonstrated experience in analytical development and characterization of peptides, antibodies, bioconjugates, and/or other complex modalities
• Strong hands-on experience in analytical method development, optimization, qualification/validation, and transfer
• Proficiency with relevant analytical characterization techniques, including capillary electrophoresis, iCIEF, and LC (e.g., RP, SEC, IEX)
• Experience supporting drug substance and/or drug product development, including process development, formulation development, process characterization, or stability programs
• Excellent interpersonal, written, and oral communication skills, with demonstrated ability to work effectively on cross-functional teams
• Strong scientific problem-solving and data interpretation skills, with the ability to independently investigate complex analytical challenges
• Working knowledge of cGMP expectations applicable to analytical development of drug substance and drug product
• Knowledge of applicable FDA, EMA, and ICH regulatory expectations and guidance

Nice To Haves

• Additional experience with LC-MS, peptide mapping, SDS-PAGE, ELISA, cell-based potency assays, and glycoprotein/carbohydrate characterization is a plus

Responsibilities

• Lead analytical development and characterization activities for peptides, antibodies, and bioconjugates, using techniques such as capillary electrophoresis, iCIEF, LC (e.g., RP, SEC, IEX), mass spectrometry, and other relevant characterization technologies
• Independently develop, optimize, qualify, validate, and transfer analytical methods in support of programs from preclinical development through commercialization
• Serve as an analytical lead on cross-functional project teams and maintain accountability for analytical deliverables supporting CMC, process development, formulation development, and manufacturing activities
• Independently design, execute, analyze, and interpret laboratory work while ensuring appropriate documentation and safe laboratory practices
• Apply scientific expertise and develop innovative analytical approaches to address complex characterization and method-development challenges
• Support analytical method transfer, external testing, manufacturing activities, and interactions with contract laboratories and other external partners
• Leverage scientific literature, ICH and other regulatory guidance, and practical experience to inform analytical development and CMC strategies
• Contribute to departmental scientific capabilities, best practices, policies, and strategies
• Build effective internal and external scientific relationships and collaborate across functions
• Clearly communicate and present scientific findings, conclusions, and recommendations to audiences across the organization
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree