22 days old

Sr. R&D Specialist - Stability (Northfield, IL)

Medline Industries, Inc.
Northfield, IL 60093
  • Job Code
    RES010044
The Sr R&D Specialist - Stability is responsible for contributing to the development of new products and technologies within the R&D group. The role will be a subject matter expert and will facilitate project needs related to stability testing, expiration dating of products, justifications, and risk assessments.

Major Responsibilities:

  • Plan and execute or otherwise facilitate testing required in support of a product claim.
  • Author, review, and approve stability protocols and reports.
  • Track, compile, and review stability studies and results needed in support of product requirements and regulatory submissions such as 510k's, CE technical files, and ANDA/NDAs.
  • Compile technical justifications and data summaries.
  • Identify and support the development of product requirements, performance attributes, and quality specifications for stability related studies. Coordinate verification and validation activities.
  • Review and trend stability results to identify product and/or process improvement opportunities and lead implementation efforts.
  • Ensure compliance of all stability related activities with applicable regulatory and standards requirements.
  • Act as a lead for internal and external audits.
  • Compile risk assessments, identify gaps, and propose solutions.
  • Lead stability related assessments and propose paths to move forward based on data trends from regression analysis.
  • Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new standards.
REQUIREMENTS INCLUDE:

Education

  • Bachelor of Science in Chemistry, Biology or related field.

Work Experience
  • At least 4 years of experience in a medical device or pharmaceutical related field.
  • Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.
  • Knowledge of CE technical files.
  • Experience with risk assessment and root cause analysis.
  • Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
  • Experience communicating with internal and external business partners and cross functional teams with various audiences.
  • Experience in project management skills, with ability and proven track record to plan, manage and develop strategic initiatives to successful goal completion.
  • Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
  • Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.
  • Ability to influence and motivate others to drive results in a multi-location and matrixed environment.
  • Position may require travel up to 10% of the time for business purposes (domestic and international).






Posted: 2020-11-07 Expires: 2020-12-06
Sponsored by:
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Sr. R&D Specialist - Stability (Northfield, IL)

Medline Industries, Inc.
Northfield, IL 60093

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