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).
