Analytical Development Manager

Hayward, CA
Full-Time
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Summary/Purpose of Job

Leadership in the area of analytical development at NANOSYN. To ensure availability of appropriate and accurate analytical methods and providing testing

Essential Duties/Responsibilities

Core Responsibilities:

  • Timely development of analytical methods for in-process and release testing at various stages of product life cycle
  • Providing technical and analytical assistance/solution in impurity identification efforts
  • Assessment of test methods provided by clients
  • Assessment of analytical efforts and their cost on new (potential) projects.
  • Ensuring proper record-keeping, full traceability, and efficient communication of analytical findings, observations and results across organization
  • Managing a library of analytical methods

Member of the Quality Unit:

  • Supporting QC activities, as needed
  • Providing analytical development reports to QC
  • Participation in development of analytical validation/qualification/degradation/stability studies protocols and reports (including analytical test methods used in cleaning validation/verification)
  • Technical assistance in establishment of specifications for Active PharmaceuticalIngredients
  • Providing technical coaching to colleagues
  • Providing assistance during cGMP audits and inspections

Services:

  • Performing and/or providing assistance for analytical testing for R&D and cGMP applications, as needed
  • Providing training to chemists on developed methods and setting the methods on R&D equipment
  • Providing training on equipment use

Equipment:

  • Troubleshooting of all analytical equipment in the facility

Other:

  • Helping create a positive work environment
  • Other reasonable duties may be assigned as necessary

Qualification Requirements

  • Advanced degree in chemistry
  • Minimum 5-year experience in analytical development, validation and testing in QC environment for various compounds
  • Strong analytical skills
  • Hands-on experience with a broad range of analytical instrumentation, including HPLC, GC, MS, FTIR, UV-Vis Spectrophotometry and new analytical techniques
  • Strong organizational skills and ability to multitask
  • Knowledge of regulatory requirements, cGMP and ICH guidelines
  • Strong communication skills

Physical Demands/Work Environment

  • Ability to safely handle hazardous materials
  • Ability to lift 50 pounds
  • Ability to bend to reach floor level

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