Research Scientist II / Sr. Manager - Analytical Stability

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/02/17
Foster City, CA
11 - 15 years experience
Salary depends on experience
Posted on 08/02/17

Specific Responsibilities & Skills for the Position:

  • Establish stability standards, business processes, and tools for management of Gilead stability programs and drive continuous improvement.
  • Oversee day-to-day operation of Stability (Stability protocol design and execution, stability chamber maintenance, interactions with partners and other collaborators).
  • Provide both technical and operational chemistry expertise (Pharmaceutical Chemistry/Stability) for training, product investigations, deviations, CAPA, quality and operational improvements, etc., to ensure continued compliance with regulations.
  • Provide key leadership, direction, and technical expertise to the Stability group and support teams to ensure product quality guidelines are consistently met.
  • Coordinate timely and right the first time delivery of stability results required by CMC Regulatory groups, and for support of Manufacturing and laboratory investigations.
  • Perform critical and scientifically sound data analysis and interpretation, including statistical analysis for comparability studies, shelf-life, degradation rates, trending, specification setting, and impact.
  • Champion specification setting initiatives in support of product development, manufacturing and regulatory filings.
  • Advise Manufacturing, QA, RA, Facilities and Material Management on stability strategy, regulatory requirements, and stability issues associated with products.
  • Lead the stability topics in inspections conducted by external regulators and business partners to defend product shelf life.
  • Serve as a role model for behavior that is consistent with the mission, vision and values of the PDM/AO organization with respect to quality, safety, performance, compliance and collaboration.

Essential Functions:

  • Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
  • Applies the principles and techniques of Analytical Chemistry to products and problems.
  • Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools.
  • Working under general supervision, plans designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances.
  • Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
  • Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
  • Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
  • Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • May make contributions to scientific literature and conferences or regulatory filings.
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.

Knowledge, Experience & Skills

  • PhD with Post Doc in Chemistry with industry experience.
  • BS or MSdegree with extensive industry experience.
  • Strongly prefer minimum MA/MS in Analytical Chemistry, Pharmaceutical Chemistry, or related field with 10+ years of supervisory experience in an Analytical Testing Laboratory or QC Stability (Ph.D. preferred).
  • Must have expert knowledge in statistical analysis and trending of stability data, and be well-versed in current stability strategies and requirements within the pharmaceutical industry.
  • Excellent communications skills are required to ensure effective cross-functional interactions and timely issue escalation to senior management.


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