Job Details

About The Role

The successful candidate will independently conduct laboratory experiments in support of Chemical Development projects. Initially, analytical support will be provided to the Neurocrine late-stage program working collaboratively with international CMC Analytical development and other teams ensuring methods for regulatory starting materials and intermediate methods are ready for validation at these organizations. In addition to familiarity with headspace GC, modern HPLC, and MS, the individual selected to fill this role must work collaboratively with his or her peers in large open well equipped analytical labs. The individual who is hired is expected to effectively document research and conduct work in a safe manner in accordance with company, departmental, and regulatory guidelines.

Your Contributions (Include, But Are Not Limited To):

• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug products, and packaging materials

• Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making

• With supervision, plans and executes in-house stability studies for drug substance's, intermediates, and prototype drug products

• With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results

• With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development

• Recognizes and responds to unexpected or anomalous observations in all activities

• Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training

• Provides detailed reviews of peer generated data as well as that generated from contracted service providers

• Maintains the inventory of laboratory consumables and clean glassware

• Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies

• Performs other duties as assigned

Requirements

• BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR

• MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above OR

• PhD in chemistry or closely related field and some industry or relevant experience a plus

• Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation

• Practical working knowledge of conducting HPLC analysis and troubleshooting

• Some expertise in evaluating analytical data and drawing meaningful conclusions

• Knowledge of cGMP expectations for laboratory records and quality systems

• Ability to provide ideas for process improvements

• 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 of individuals to meet goals, tasks in a timeline driven setting

• 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/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, 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.