Senior Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Analytical project leader responsible in performing analytical chemistry research to develop assays based on new and existing methodologies. Responsible for all analytical activities for an assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases). Develops, establishes and validates testing methodology used to control raw materials, production intermediates and final products. Establishes, validates and documents new or existing compound specific methods. Conducts testing of analytical samples for the laboratory area, the separation and characterization of drug candidates, develops assays in support of new formulations, and other analytical methods of development. Conducts work in the spirit of cGMP, with a focus on safety and regulatory requirements.

Requirements

• BS/BA degree in chemistry or closely related field and 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry.
• Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms.
• Previous supervisory and/or project management experience is preferred
• OR MS/MA degree in chemistry or closely related field and 3+ years of similar experience noted above
• OR PhD or equivalent in chemistry or closely related field and some relevant experience; may include postdoc experience
• Effective report writing and oral presentations skills are required
• Excellent written and verbal communication skills are required
• Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
• Ability to creatively solve complex problems in a team environment
• Demonstration of cross-functional understanding related to drug development
• Effectively see projects to completion
• Understands how to effectively negotiate, persuade, and influence
• Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms
• A working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issues
• Must have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD
• Demonstrates solid level of understanding project / group goals and methods
• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
• Able to explain the process behind the data and implications of the results
• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
• Strong knowledge of scientific principles, methods and techniques
• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
• Ability to work as part of a team; may train lower levels
• Ability to leading teams
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture of scientific impact on team
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills

Nice To Haves

• Previous supervisory and/or project management experience is preferred

Responsibilities

• Act as an analytical project leader
• Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases)
• Develops and validates test methods at NBI for drug substances (API), intermediates and drug product
• Supports chemical development and formulation development
• Preformulation collaboration to Pharmaceutical Sciences
• Tests and provides a complete characterization of toxicology supplies
• Structural characterization of drug substance molecules, identification of impurities/degradants in API and drug product
• Audits and selects contract service providers (CSP) to conduct GMP analytical testing for Neurocrine projects
• Analytical technology transfer to CSP
• Overviews GMP analytical testing of clinical supplies by CSPs
• Facilitates and leads investigations for out of specification and out of trend results
• Prepares of the analytical sections of regulatory documents, protocols and reports
• Provides training and/or supervision to junior staff, as needed
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• 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: Mid Level
• Number of Employees: 1,001-5,000 employees