Scientist, Analytical Development

Neurocrine Biosciences

2d

About The Position

The Analytical Development Scientist- Reference Standards is responsible for the development, qualification, and lifecycle management of compendial and internal reference standards supporting biologics and small-molecule programs. This role executes and supports analytical method development, verification, and validation activities to ensure the suitability of testing used for identity, purity, potency, and stability assessments. The scientist performs data-driven evaluation of materials across all stages of development in compliance with GMP, safety, and regulatory requirements, and collaborates cross-functionally to support CMC strategies and regulatory submissions.

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, qualifies, and executes analytical methods for the characterization, qualification, and lifecycle management of reference standards and working standards for biologics and small-molecule programs, including compendial and non-compendial materials
• Applies and optimizes compendial (USP/EP/JP) and non-compendial analytical methods to support identity, purity, potency, content, and stability testing of reference standards, drug substances, drug products, raw materials, and critical reagents
• Supports method development, verification, and validation activities to ensure suitability of analytical procedures used for reference standard qualification and routine testing across development stages
• Performs analytical testing using a variety of instrumental techniques (e.g., chromatography, spectroscopy, electrophoresis, and bioassays as applicable) in compliance with GMP, safety, and regulatory requirements
• Evaluates analytical data, investigates atypical results, and contributes to documentation supporting reference standard qualification, change control, and regulatory submissions (IND/IMPD/NDA/BLA)
• Collaborates with CMC, Analytical Development, Quality Control, and external vendors to ensure availability, comparability, and traceability of internal and compendial reference standards
• Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, 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

Benefits

• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees