Scientist, Product Development Operations 5/5/2020
San Diego, CA
JOB DESCRIPTIONAPPLY WHO WE ARE:
At Neurocrine Biosciences, we pride ourselves on having a strong, distinctive 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 patient suffering and enhance lives.
WHAT WE DO:
Neurocrine Biosciences (Nasdaq: NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.
The company s diverse portfolio includes two FDA-approved treatments INGREZZA (valbenazine) for tardive dyskinesia and ORILISSA (elagolix) for endometriosis*, as well as clinical development programs in multiple therapeutic areas, including Parkinson s disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome.* As part of a strategic collaboration with Voyager Therapeutics, Neurocrine Biosciences is also focused on the development of investigational gene therapy programs for the treatment of severe neurological diseases, including Parkinson s disease and Friedreich s ataxia. (*in collaboration with AbbVie)
ABOUT THE ROLE:
Among other responsibilities, the Scientist is responsible for supporting the technology transfer (formulation, process, analytical methods, and specifications) of late-stage development and clinical/commercial drug product manufacturing from a transferring drug product manufacturing site to a receiving site.
YOUR CONTRIBUTIONS (INCLUDE, BUT ARE NOT LIMITED TO):
* Support the technology transfer (formulation, process, analytical methods, and specifications) of late-stage development and clinical/commercial drug product manufacturing from a transferring drug product manufacturing site to a receiving site
* Manage project timelines to support Product Development goals from both a technical and business operations perspective
* Perform technical review of manufacturing protocols, reports, and batch records
* Provide process development and technical support for drug products through the end of the technology transfer phase of the project, including CTM and/or Process Performance Qualification (PPQ) batches
* Support the manufacture of drug products at contract manufacturing sites, acting as person-in-plant, as needed. (Up to 20% travel may be required)
* Collaborate with the Process Design and Engineering and Formulation groups throughout development to identify a drug product manufacturer based on the proposed process
* Assist in drug product manufacturing site evaluation/selection, preparation of the request for proposal (RfP) and contracting process
* Collaborate with multiple functional lines (CMC, Regulatory, Quality Assurance) within the company
* Facilitate and schedule meetings with NBI personnel, as needed, to ensure cross-functional participation on the technology transfer teams
* Lead weekly or bi-weekly NBI-CMO project team meetings and update the team on progress and timelines
* Perform other duties as needed or assigned
* BS/BA degree in Chemistry, Biochemistry or related discipline and 2+ years of Pharmaceutical industry experience. Hands-on experience executing and interpreting pharmaceutical analysis, and drug product unit operation processing is preferred, OR
* MS/MA degree in Chemistry, Biochemistry or related discipline preferred and some industry experience as noted above preferred, OR
* PhD in Chemistry, Biochemistry or related discipline and some relevant experience preferred.
* Must have a good understanding of cGMPs relating to early drug product manufacturing.
* Must be self-motivated, detail-oriented, possess familiarity of physical & analytical techniques as they pertain to biopharmaceutical properties.
* Ability to learn quickly and think independently.
* Exhibit strong scientific acumen.
* Familiarity with the development and execution of chemical and instrumental methods (e.g. Disintegration, Dissolution, Density, Flow, UV, HPLC, GC, TGA, DSC, PXRD, GVS, MS, FTIR, KF, PSD, PLM, SEM) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials.
* Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
* Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
* Strong knowledge of one scientific discipline
* Good knowledge of scientific principles, methods and techniques
* Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
* Ability to work as part of a team
* Strong computer skills
* Good communications, problem-solving, analytical thinking skills
* Detail oriented
* Ability to meet deadlines
* Good project management skills
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.