Sr. Scientist/Principal Scientist, Analytical Development

Neurocrine Bioscience; San Diego (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking an experienced analytical development lead to spearhead separation method development for antibodies and bio-conjugates. This role involves guiding analytical activities from preclinical to commercial phases, ensuring compliance with cGMP and regulatory standards. The ideal candidate will have extensive experience in analytical chemistry and separation sciences, and will be responsible for leading method development, validation, and transfer activities. Join a dynamic team dedicated to improving lives through innovative biopharmaceutical solutions and contribute to groundbreaking projects that make a real difference in patients' lives.

Qualifications

• 12+ years of experience in analytical/pharmaceutical development.
• Expert knowledge of analytical chemistry and separation sciences.
• Experience in method development, validation, and transfer.

Responsibilities

• Lead analytical method development and validation for antibodies.
• Ensure compliance with cGMP and regulatory requirements.
• Represent analytical development on cross-functional teams.

Skills

Analytical Chemistry

Separation Sciences

Interpersonal Skills

Communication Skills

Laboratory Skills

Method Development

Regulatory Knowledge

Education

BS/BA in Analytical Chemistry

MS/MA in Analytical Chemistry

PhD in Analytical Chemistry

Tools

UPLC

HPLC

Mass Spectrometry

ELISA

Capillary Electrophoresis

Job description

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

This position will serve as the SME for separation method development and analytical development lead for multiple projects, with a focus on antibodies and bio-conjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify separation methods used to control in process intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies. 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 separation analytical method development and validation/qualification activities for the characterization of antibodies and/or bio-conjugates utilizing advanced separation techniques (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF etc.) 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.
• Direct laboratory work and/or lab personnel within the company and at external vendors.
• Ensure laboratory safety practices.
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors.
• Provide inputs into CMC regulatory documentation and 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 findings at varying levels across the company.
• Other duties as assigned.

Requirements:

• BS/BA in Analytical Chemistry or related discipline and 12+ 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 10+ years of experience OR
• PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience.
• Expert knowledge and understanding of analytical chemistry, separation sciences, and a thorough understanding of bioprocess as well as formulation development.
• Extensive experience and expertise with antibody and bio-conjugate modalities compounds, focusing on analytical development and separation method development.
• Excellent interpersonal skills with strong oral and written communication abilities.
• Excellent laboratory and productivity skills.
• Proficient in characterization of antibody and bio-conjugate modalities using various modern technologies. They may include but not limited to size exclusion liquid chromatography, reverse phase liquid chromatography, hydrophilic interaction liquid chromatography, ion exchange liquid chromatography, hydrophobic interaction liquid chromatography, mixed mode liquid chromatography, UPLC/HPLC, capillary electrophoresis (Maurice/PA800+), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, and molecular analysis.
• 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.

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.