TEMP - Scientist, Analytical Chemistry, CMC

Neurocrine Biosciences•San Diego, CA

2d•$88,000 - $121,000

About The Position

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.

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

Responsibilities

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