Scientist, Analytical Development

Neurocrine Biosciences

98d • $88,000 - $127,550

About The Position

The Analytical Scientist is responsible for performing analytical development based on new and existing methodologies for small molecule pharmaceuticals. This role involves conducting analytical laboratory activities to support the manufacturing of drug products intended for use in clinical studies across all phases. The scientist will develop, establish, and validate testing methodologies used to control final drug products, as well as establish, validate, and document new or existing compound-specific methods. The position requires conducting testing of analytical samples, separation and characterization of drug candidates, and developing assays in support of new formulations, all while adhering to cGMP standards with a focus on safety and regulatory requirements.

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.
• MS/MA degree in chemistry or closely related field preferred and some similar industry experience.
• PhD in chemistry or closely related field and some industry or relevant experience is a plus.
• Effective report writing and oral presentation skills.
• Excellent written and verbal communication skills.
• Ability to build excellent working relationships and maintain confidentiality regarding intellectual property.
• Demonstration of cross-functional understanding related to drug development.
• Practical working knowledge of conducting HPLC analysis and troubleshooting.
• Capable of evaluating analytical data and drawing meaningful conclusions.
• Knowledge of cGMP expectations for laboratory records and quality systems.
• Ability to provide ideas for process improvements.
• Good knowledge of scientific principles, methods, and techniques.
• Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools, including HPLC, dissolution apparatus per USP, Karl Fisher.
• Ability to work as part of a team to meet goals in a timeline-driven setting.
• Strong computer skills.
• Strong communication, problem-solving, and analytical thinking skills.
• Detail-oriented yet able to see the broader picture of scientific impact on the team.
• Ability to meet multiple deadlines with a high degree of accuracy and efficiency.
• Strong project management skills.

Responsibilities

• Develops and executes instrumental methods (e.g. HPLC, dissolution) to support manufacturing of drug products intended for use in clinical studies.
• Conducts in-house analytical development laboratory activities to support drug product knowledge and understanding (forced degradation, ASAP, developmental stability).
• Follows established test methods, procedures, regulatory guidance (e.g. ICH), and pharmacopeia chapters to generate data essential for strategic decision making.
• Plans and executes laboratory testing of in-house analytical method development activities, analytical method validation, stability studies for drug products, and formulation development support.
• 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 development and formulation development.
• Recognizes fundamental anomalies in data points, inconsistent results, and identifies issues in experiments/processes.
• Interprets experimental outcomes and communicates results to the broader team.
• Creates and reviews technical reports and oral presentations of various analytical activities.
• Maintains complete and accurate records of laboratory work in conformance with company SOPs, GxP expectations, and training.
• Provides detailed reviews of peer-generated data as well as that generated from contracted service providers.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage
• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in equity-based long-term incentive program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees