Manager, Bioanalytical

Neurocrine Biosciences • San Diego, CA

5d

About The Position

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. This role is responsible for directing bioanalytical activities across multiple drug development programs for generation of critical PK/TK and immunogenicity data for preclinical and/or GLP Toxicology studies, while managing both internal teams and CRO partnerships. Requires extensive expertise in in vivo PK/TK study conduct, bioanalytical method development and validation across various modalities including small molecules, peptides, and biologics, with a strong foundation in regulatory requirements and GLP compliance. Oversee critical bioanalytical infrastructure, including method development, validation, and sample analysis for non-regulated and regulated studies while building and maintaining relationships with external CRO partners. Demonstrate exceptional project management skills, with proven ability to manage multiple concurrent programs, budgets, and timelines while ensuring quality deliverables.

Requirements

• BS/BA degree in chemistry/biology or a related discipline and 6+ years of experience in bioanalytical and pharmacokinetic/toxicokinetic project management, CRO management and pharmacokinetic modeling.
• Small and Large molecule bioanalysis, non-compartmental PK data analysis
• Master's degree in chemistry/biology or a related discipline and 4+ years of similar experience noted above
• PhD in chemistry/biology or a related discipline and 1+ years of similar experience noted above
• Extensive expertise in in vivo animal dosing techniques and microsampling for PK studies
• Extensive expertise in bioanalytical method development, validation, and sample analysis across multiple modalities (small molecules, peptides, biologics, conjugates, oligonucleotides)
• Demonstrated experience with regulatory requirements (FDA, EMA, ICH guidelines) and GLP regulations, including successful contributions to regulatory submissions
• Proven track record in CRO management, vendor relationships, and oversight of outsourced bioanalytical studies
• Experience in working with external CRO partners in generation of critical PK/TK and immunogenicity data for preclinical, and/or GLP toxicology and FIH studies
• Strong technical background in various bioanalytical techniques including LC-MS/MS, immunoassays, and biomarker analysis
• Exceptional project management skills with experience in budget management, resource allocation, and timeline tracking across multiple concurrent programs
• Demonstrated leadership ability in directing cross-functional teams, mentoring staff, and driving process improvements
• Excellence in technical writing, presentation skills, and cross-functional communication with ability to influence key stakeholders
• Proven success in establishing and maintaining bioanalytical infrastructure, including implementation of tracking systems and quality control procedures
• Strong strategic thinking and problem-solving abilities with a track record of driving program success and delivering high-quality results in a fast-paced environment
• Ability to mentor and direct the day-to-day work of less experienced team members
• Excellent computer skills, strong problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong written and verbal communication skills

Responsibilities

• Directs the activities of bioanalytical scientists in support of the research and/or development of an organization's products, projects and programs
• Monitors and evaluates completion of tasks and projects
• Will manage conduct of BA/PK/TK studies internally as well as at external CROs
• Lead and manage non-regulated and regulated bioanalysis activities for multiple drug development programs, from preclinical development through First-in-Human (FIH) studies
• Build and strengthen bioanalysis infrastructure internally as well as with external CRO partners to support preclinical, GLP Toxicology and FIH studies for multiple modalities including small molecules, peptides, biologics, conjugates, and oligonucleotides
• Oversee bioanalytical method development, validation, and sample analysis for preclinical and/or clinical studies
• Collaborate with internal Neurocrine teams to generate critical reagent generations for bioanalytical method development
• Implement and maintain project tracking systems for bioanalytical methods, sample analysis, and critical reagents
• Participate in CRO vendor qualification and audits
• Will contribute to the preparation and/or review of regulatory submissions and study reports
• Mentor and train team members in bioanalytical procedures and regulatory requirements
• 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: Manager