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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
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How to Apply:
Individuals interested in applying for this position must email resumes to Neurocrine Biosciences, Inc. at talent@neurocrine.com 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.
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