Analytical Development Stability Manager

Neurocrine Biosciences • San Diego, CA

69d • $117,300 - $170,050

About The Position

Independently manages multiple stability programs with high complexity for development stage pharmaceutical compounds (drug substances and drug products). Reviews stability protocols, reports, and data from internal labs and contract service organizations (CSOs). Supports shelf-life/retest dating, data trending, and specification revision for drug substances and drug products. Coordinates internal stability samples for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for junior employees.

Requirements

• Bachelor's degree in Chemistry or other and 8+ years of analytical experience in the life science pharmaceutical industry or relevant industry experience OR
• Master's degree in Chemistry or other and 6+ years pharmaceutical industry life science experience OR
• PhD in Chemistry or other life science and 4+ years of related experiences. Some management or lead experience is preferred
• Good understanding of how the team/work area relates to other areas and how to improve efficiency and produce high quality work on problems with cross factional impact
• Identifies and resolves technical, operational, and organizational problems or problems relating to own discipline
• Frequently works cross functionally as the representative for their areas
• Ability to meet deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Strong project management skills
• Strong knowledge in stability protocol design under different storage conditions, packaging configurations, and climatic zones
• Strong knowledge in trending quality attributes such as degradation products and shelf-life extension
• Strong knowledge of specifications, method validation and transfer
• Previous stability management and analytical data review experience is highly desired
• Experience in managing CSOs
• Familiar with bulk hold, patient in-use, and cycling studies
• Working knowledge of formulation development for oral and parenteral products and DS process development
• Familiar with degradation pathways and forced degradation studies
• Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1
• Highly knowledgeable of standard analytical techniques (HPLC, GC, FTIR, XRPD, Dissolution and wet chemistry)
• Excellent oral and written communication skills with strong interpersonal skills
• Competency in Word, Excel, PowerPoint, and statistical analysis software such as JMP, SLIMStat, or Minitab
• Contributes to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration

Responsibilities

• Responsible for resource allocation to achieve team objectives and goals
• Develops and evaluates personnel to ensure the efficient operation of the function
• Manages multiple stability programs independently for development-stage pharmaceutical products (drug substances and drug product) for ICH, bulk hold, patient in-use, cycling studies, etc.
• Tracks stability test schedules at contract service organizations (CSOs)
• Reviews and/or approves stability protocols
• Reviews, summarizes, and trends stability data with statistical software such as SLIMStat
• Determines shelf life or retest periods
• Generates stability protocols, reports, and presentations
• Ability to lead multiple stability programs with moderate to high complexity within CMC
• Coordinates communication with internal customers and external vendors
• Coordinates internal stability samples for storage and testing
• Reviews and approves specifications, change controls, out-of-specification (OOS), out-of-trend (OOT) and deviation reports
• Facilitates and leads investigations for out of specification and out of trend results in stability studies
• Authors and/or reviews Department SOPs related to stability programs
• Authors and/or reviews appropriate development reports and stability related sections of regulatory filings, such as INDs, IMPDs, NDAs, etc.
• Experienced user for document management systems such as Veeva Quality and Veeva RIM
• Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed
• Serves as a stability lead for a CMC project team or a working group
• Assists in method development and validation activities as needed
• Provides training and / or supervision to junior staff
• Leads department initiatives
• Performs 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

What This Job Offers

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