TEMP - Scientist, Analytical Chemistry, CMC

Neurocrine Biosciences•San Diego, CA

About The Position

About the Role: Independently conduct laboratory experiments to support small-molecule projects for Chemical Development. The initial focus will be on providing analytical support for a late-stage Neurocrine program, including collaboration with international CMO partners to ensure the development and validation of methods for regulatory starting materials and intermediates. Responsibilities also include troubleshooting out-of-specification (OOS) and out-of-trend (OOT) results. Proficiency in modern HPLC, mass spectrometry (MS), and Headspace GC is essential. Strong team player, contributing effectively in a large, open, and well-equipped analytical laboratory. Excellent documentation practices and a strong commitment to safety and compliance with company, departmental, and regulatory guidelines are required.

Requirements

BS/BA degree in analytical chemistry or closely related field and 2+ years (2-5 years preferred) 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 analytical chemistry or a closely related field preferred, and some similar industry experience noted above, OR PhD in analytical chemistry or a closely related field, and some industry or relevant experience is 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 communication, problem-solving, and analytical thinking skills
Detail oriented
Ability to meet deadlines
Good project management skills

Responsibilities

Develops and executes analytical instrumental methods (e.g., HPLC, GC, HS-GC, MS, NMR, TGA, DSC, PXRD, PSD, KF, and FTIR) of analyses for development compounds, drug substances, raw materials, and intermediates
Accurately follows established test methods, procedures, and pharmacopeia chapters to generate data essential for strategic decision making
With supervision, plans and executes in-house stability studies for drug substances, 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
Collaboratively plans and executes cross-functional studies for chemical and formulation development under supervision
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 to 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