Principal Scientist, Analytical Development

neurocrine; San Diego (CA); On-site; USD 210,000 - 280,000; Full time

Job summary

Neurocrine Biosciences in San Diego seeks an Analytical Development Lead to guide multiple programs focusing on oligonucleotides and antibody oligo conjugates. You will develop, qualify and transfer analytical methods for drug substance and product, ensuring cGMP compliance and alignment with regulatory expectations.

You will lead cross-functional teams, mentor scientists, and drive innovation in analytical platforms, leveraging IP-RP, AEX, LC-MS, SEC, and related techniques to enable

Qualifications

• BS/BA or higher in analytical chemistry/biochemistry with relevant pharmaceutical development experience.
• Experience with method transfer in Analytical Chemistry.
• Expert knowledge of cGMP requirements in drug substance and product.
• Experience with oligos and bioconjugates is a plus.
• Excellent interpersonal and written/oral communication skills.

Responsibilities

• Lead analytical development for analysis and characterization of oligos and/or antibody oligo conjugate (AOC).
• Develop, qualify, and transfer analytical methods within cGMP in support of preclinical through commercialization.
• Represent Analytical Development on cross-functional teams and manage CMC deliverables.
• Conduct laboratory work independently and train lab personnel; ensure safety.
• Oversee analytical transfers, manufacturing support, and contractor interactions.
• Leverage literature and regulatory guidance to influence CMC strategies.
• Present findings across the company and contribute to department strategies.

Skills

Analytical chemistry

Biochemistry

cGMP compliance

Cross-functional collaboration

Communication skills

Education

BS/BA in Analytical Chemistry/Biochemistry

MS/MA in Analytical Chemistry

PhD in Analytical Chemistry or related discipline

Tools

IP-RP

AEX

LC-MS

SEC

Capillary Electrophoresis

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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.

For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role:

This position will serve as the analytical lead for multiple projects, with a focus on oligonucleotides and/or bioconjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify testing methods used to control raw materials, in process, intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies, with special emphasis on advancing innovation in analytical techniques and platforms. Responsible for keeping work in compliance with cGMP, safety, and regulatory requirements. Participates in analysis and evaluation of material and products at all stages of development process. Monitors and evaluates completion of tasks and projects.

Your Contributions (include, but are not limited to):

• Lead analytical development activities for analysis and characterization of oligos and/or antibody oligo conjugate (AOC) utilizing IP-RP, AEX, LC-MS, MS/MS, SEC techniques
• Lead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercialization
• Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors
• Ensure safe laboratory practices
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
• Support off-site analytical transfers, manufacturing support, and interaction with contractors
• Authorize analytical related CMC regulatory documents and lead the supporting work
• Leverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategies
• Contribute to development of policies and department strategies
• Build and enhance internal and external professional relationships
• Support career development and technical growth of team members
• Present finding at varying levels across the company
• Other duties as assigned

Requirements:

• BS/BA in Analytical Chemistry/Biochemistry or related discipline and 15+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Chemistry OR
• MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
• Experience and expertise with oligos and/or bioconjugate compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterization
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Proficient in characterization of oligos and/or antibody oligo conjugate (AOC) using various modern technologies. They may include but are not limited to LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, MS/MS
• Method development, validation, qualification, 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

Neurocrine Biosciences is an EEO/Disability/Vets employer.

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