Senior Team Lead Jobs

Senior Team Lead, Analytical Development

Company Summary:

The Medical Device division of a large, global biotechnology company is currently seeking a driven, motivated, and enthusiastic Senior Manager to join to help build out an analytical development team for extractables & leachable studies. This position is located in Rhode Island at the Company’s cell and genetic therapies R&D site. You will play a key role in building and leading an analytical development team to design test methods for E&L testing.

The Senior Team Lead will be responsible for:

• Employing Design of Experiments (DoE) principles when designing assays
• Serving as an SME to Quality teams for assay transfers and qualifications
• Authoring project progress reports, analytical development protocols, and detailed lab documentation
• Leading a small team (up to 4 members) in creating, conducting, and assessing studies for developing and validating test methods, showcasing feasibility, and characterizing material and assembled device products using a variety of analytical techniques.
• Ensuring ISO 10993 guidelines are followed in E&L studies as well as maintaining regulatory compliance

The Senior Team Lead should have the following qualifications:

• PhD degree in Analytical Chemistry, Polymer Chemistry, Materials Science, or a related scientific field with 5+ years of industry experience in analytical/assay development OR Master’s degree with 10+ years of experience
• Analytical method development, validation, and transfer
• Excellent communication and interpersonal skills, with the ability to effectively lead small teams to project completion
• Technical skills including FTIR, DSC, TGA, LC-MS, GC-MS, HPLC, UPLC, SEC, GC, and mechanical material characterization
• Knowledge of regulatory guidelines concerning impurities (such as ICH Q2, Q3D, M7) as well as Extractables and Leachables (ISO 10993).

Benefits:

• Opportunity to work for a highly recognized company
• Company stocks and annual bonus
• Competitive health, vision, and dental benefits with a 401(k) plan