Sr. Scientist, CMC Antibody Development, Biologics (#SJ-0802)

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)

_

• Responsible for pre-clinical and clinical phase scientific process research and development for gene therapy and antibody modalities, including internal development and manufacture of GLP (Good Laboratory Practice), as well as support for external manufacture of GMP (Good Manufacturing Practice) drug substance

• Make significant upstream and/or downstream laboratory contributions in order to enable drug-substance process optimization to ensure robust delivery of the Neurocrine pipeline

• Provide project leadership or support for CMC (Chemistry, Manufacturing, and Controls) programs, and lead work streams and platform projects within the Chemical Development team

• Support project planning efforts and participate in cross-functional teams representing Chemical Development

• Maintain accountability for assigned deliverables for R&D and manufacturing plans for Chemical Development projects

• Ensure laboratory work is done productively with adherence to laboratory practices

• Perform process R&D and optimize drug substance processes

• Recommend alternatives and perform research toward new methods and techniques to solve problems

• Assist with managing development, manufacturing activities and may interact with contractors

• Provide input for portions of CMC regulatory documentation and supporting work

Requirements:

• Master’s degree or equivalent in Chemistry, Chemical Engineering, or a related field

• 3 years of experience in the field of biologics process development or biologics manufacturing

• Employer will accept a Bachelor’s degree or equivalent in Chemistry, Chemical Engineering, or a related field and 4 years of experience in the field of biologics process development or biologics manufacturing in lieu of a Master’s degree or equivalent and 3 years of experience

• Work experience to include: (1) 3 years of experience (or 4 years of experience with a Bachelor’s degree) with scientific principles, methods, and techniques. (2) 3 years of experience (or 4 years of experience with a Bachelor’s degree) working with laboratory equipment and tools, including incubators, biosafety cabinets, rocking bioreactors, and stirred tank bioreactors of scales from 250mL to 50L. (3) 3 years of experience (or 4 years of experience with a Bachelor’s degree) with aseptic technique. (4) 3 years of experience (or 4 years of experience with a Bachelor’s degree) with gene therapy or antibody development and manufacture. (5) Recognizing anomalous and inconsistent results and interpreting experimental outcomes. (6) Explaining the process behind the data and implications of the results and planning next steps. (7) Biologics (upstream) as well as current techniques and literature. (8) Drug substance manufacturing, both internal and with external partners. (9) Good understanding of cGMP requirements and regulatory aspects of biologics. (10) Demonstration of cross-functional understanding related to drug development

• Any and all experience may be gained concurrently

• The position requires 5% domestic travel and 15% international travel; travel expenses paid by employer

• 40 hrs./wk.

• Salary: $110,800.00 to $177,400.00/yr.

• Address of employment: Neurocrine Biosciences, Inc. located at 6027 Edgewood Bend Court, San Diego, CA 92130

• #LI-DNI

How to Apply:

Individuals interested in applying for this position must email resumes to Neurocrine Biosciences, Inc. at [email protected] referencing Job #SJ-0802, or mail resumes to Neurocrine Biosciences, Inc., Attn: Elina Yapparova, Job #SJ-0802, 6027 Edgewood Bend Court, San Diego, CA 92130.

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

_