Process and Stability Statistician
Job Details
Scientific Protein Laboratories - Waunakee, WI

JOB SUMMARY

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Process and Stability Statistician.

The Process and Stability Statistician is a statistics and data analysis subject matter expert (SME). The individual performs data analysis in support of current good manufacturing practice (cGMP) activities at SPL and Mobren. Responsibilities include authoring stability protocols, stability reports, and shelf-life reports, providing statistical support for manufacturing or analytical investigations, and completing data analysis for annual product reviews (APRs) and regulatory documents. Exceptional data analysis capability is essential. Attention to detail and working independently with minimal supervision is required.

Responsibilities include:

  • Prepares stability protocols to support the shelf-life of SPL, Mobren, and customer products.
  • Conducts stability data analysis.
  • Authors stability and shelf-life reports.
  • Performs data analysis in support of APRs and regulatory documents.
  • Provides statistical support for manufacturing and analytical investigations.
  • Participates and supports regulatory and customer audits as a data analysis and stability SME.

Job Requirements and Qualifications:

Position will be filled up to the Senior level and determined at discretion of the hiring manager.

Associate Process and Stability Statistician:

Experience: no experience required, 3 plus years direct pharmaceutical industry experience with detailed knowledge of GXP regulated environments and hands on statistics experience and experience authoring stability documents preferred.

Education: Bachelors Degree in Statistics or Mathematics required, Advanced Degree in Statistics or Mathematics preferred.

Process and Stability Statistician:

Experience: 3 plus years direct pharmaceutical industry experience with a working knowledge of GXP regulated environments and hands on statistics experience required, Direct pharmaceutical industry experience with detailed knowledge of GXP regulated environments and hands on Statistics experience and experience with authoring Stability documents preferred.

Education: Bachelors Degree in Statistics or Mathematics required, Advanced Degree in Statistics or Mathematics preferred.

Senior Process and Stability Statistician:

Experience:5 plus years direct pharmaceutical industry experience with a working knowledge of GXP regulated environments and hands on statistics experience required, 10 plus years direct pharmaceutical industry experience with detailed knowledge of GXP regulated environment and hands on statistics experience and experience with authoring stability documents preferred.

Education: Bachelors Degree in Statistics or Mathematics required, Advanced Degree in Statistics or Mathematics preferred

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

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