Scientist, Analytical Development

San Diego, CA   ·  Fulltime

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 patient suffering and enhance lives.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:

The Analytical Development Scientist will, under supervision, be responsible for development and execution of analytical test methods that facilitate drug product development / manufacturing and regulatory submissions for clinical study introduction through phase 3 trials. Activities includes test method development, qualification/validation, transfer and execution. This position is also called on to support late stage troubleshooting and development of products, processes, and methods in support of product commercialization.

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

• Develop and execute chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR, Water Content) of analyses of drug product development compounds.
• Accurately follow established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution, Content Uniformity) to generate data essential for strategic decision making.
• With supervision, plan and execute forced degradation, informal stability, and excipient compatibility studies.
• With supervision and as appropriate, assist/lead the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results.
• With supervision, collaboratively plan and execute cross functional studies for formulation development.
• Recognize and respond to unexpected or anomalous observations in all activities.
• Maintain complete and accurate records of laboratory work in conformance with company SOPs and training.
• Provide detailed reviews of peer generated data as well as that generated from contracted service providers.

Requirements:

• BS in chemistry or closely related field; minimum 5 years relevant industrial experience in an R&D/QC setting, OR
• MS with 3 years of experience as noted above.
• Proficient using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation. Experience with OpenLab CDS Chemstation a plus.
• Significant hands-on experience performing analytical testing of solid oral drug products.
• Significant practical experience conducting HPLC analysis and troubleshooting.
• Hands-on experience performing stability indicating method development.
• Significant experience performing method qualifications/validations/transfers.
• Significant practical experience performing dissolution analysis and troubleshooting. Prior experience performing dissolution method development a plus.
• Significant experience evaluating analytical data and drawing meaningful conclusions.
• Experience working in and accomplishing tasks a timeline driven setting.
• Ability to present analytical data clearly and demonstrate knowledge of the testing and the product.
• Knowledge of cGMP expectations for laboratory records and quality systems.
• Knowledge of ICH guidance and common testing per USP chapters.
• Knowledge of statistical analysis a plus.
• Strong attention to detail, excellent written and oral communication skills.
• Ability to provide ideas for process improvements.
• Ability to work with a team of individuals to meet goals.

#LI-LS1

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

Please click here to apply