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Stability Scientist

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$8.4 Billion Dollar International Nutritional Supplements company located in Orange County is looking to identify and hire a contract Stability Scientist for their Innovation & Sciences team.

 

Responsibilities:

The qualified professional will work in a team setting and under the direct supervision of the manager to assist with ensuring our products meet label claims and shelf life requirements for the global countries in which we sell products. Individuals serving in the Stability Scientist role will be responsible for designing stability protocols and reviewing data for new product development, registration and on-going business sustaining activities for maintaining the existing global product portfolio.

 

  • Developing, overseeing, and establishing strategies for stability studies of new products.
  • Monitoring product stability studies to ensure complete and accurate data is available for establishing product storage requirements and shelf-life/expiry dating periods.
  • Coordinating with cross-functional partners in Formulation, Regulatory, Packaging, and Quality Assurance to set up and maintain product stability testing protocols in accordance with the appropriate regulatory requirements.
  • Monitoring stability storage conditions, stability samples and status of laboratory test results ensuring stability programs progress according to the established protocol.
  • Ensuring and/or guiding in-house and contract labs in proper testing, storage and reporting of stability samples.
  • Alerting, investigating and/or escalating unusual observations, potential issues or any incidence of non-compliance within established protocols or procedures. Evaluating and recommending corrective and preventative actions.
  • Analyzing stability data and generating stability technical reports for regulatory submissions.
  • Contributing to critical manufacturing/laboratory investigations across multiples sites and cross-functional groups.
  • Actively participating on cross-functional teams serving as the technical expert and lead for the Stability program.

 

Required Knowledge, Skills, Abilities and/or Related Experience:

  • BS in Food Science, Chemistry, Mathematics, Statistics, Engineering or related scientific discipline
  • Min 5 years of hands on industry experience working within an FDA or similar regulated industry, preferably in the Nutraceuticals, Foods, or Pharmaceuticals industries.
  • Requires full technical proficiency in principles and practices of area of specialty.
  • Provides solutions to a variety of technical problems of simple to moderate scope and complexity using application of technical standards, principles, theories, concepts and techniques.
  • Effectively balances working independently and in collaboration with teams to lead simple to moderately complex technical projects.
  • Experience using related analytical or scientific software, databases and applications to include use of typical office suite software packages (i.e. Excel, Minitab, STARLIMS, PLM).
  • Familiar with quality control lab tools, techniques and safety principles.
  • Experience in collecting and analyzing experimental data to evaluate hypotheses and ability to make judgments based on well-supported evidence (data driven decision making).
  • Identifies and anticipates problems, reviews related information, develops and evaluates options, makes decisions and implements solutions.
  • Utilizes and partners with technical resources efficiently and employs appropriate risk mitigation to achieve project objectives
  • Effectively communicates, translates and presents technical complex data into an easy to understand manner (both verbally and written).
  • Confidently interacts with/leads cross-functional teams to achieve defined objectives through consulting and positive interaction with culturally diverse team members, external partners.
  • Excellent at planning, organizing, attention to detail, monitoring and delivering to project deadlines.
  • Processing, documenting and providing timely information/updates with a high level of accuracy in a usable format.
  • Successful approaches, tools, and techniques for dealing with changes and adapting to a changing environment; adapting as needed to meet the requirements of the business.

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