The Sr. Scientist will be an expert in the field of Extractable and Leachable testing who will be responsible for managing the Extractable and Leachable (E&L) program. The Sr. Scientist will have in-depth knowledge of the regulatory requirements as well as the technical expertise for the development and validation of analytical methods required to qualify various packaging and manufacturing process components. The Sr. Scientist will have expertise in testing for E&L using various analytical methods such as HPLC/UV, HPLC/MS GC, GC/MS, and ICP-OES.
Responsible for maintaining subject matter expertise with the latest scientific literature and industry standards for E&L, including USP chapters for packaging components and container closure systems as it applies to sterile inhalation, ophthalmic, otic and oral products.
Have an understanding of the chemistry of packaging components such as resins, polymers, foils, laminates etc.
Responsible for overseeing and leading extractable methods validation and strategies for control of leachates in pharmaceutical products.
Lead unknown compound investigations utilizing data generated by mass spectrometry and work with toxicologist and chemist to device appropriate strategies for establishing control specifications for components and drug products.
Responsible for project tracking and timely completion of projects as a project team leader.
Coordinate and lead all analytical aspects for assigned projects including customer and vendor communications.
Responsible for timely and accurate completion of assigned work.
Adhere to all applicable cGMPs, company SOPs, and health and safety procedures.
Responsible for timely and accurate documentation according to TRC’s SOPs and applicable cGMPs.
Responsible for writing laboratory SOPs, studies, protocols, and reports.
Assist in regulatory audits.
Lead OOS and deviation investigations.
BS in Chemistry or related science with a minimum of 12 years experience; preferably MS with 6 to 9 years experience working in the pharmaceutical industry in the Extractable/Leachable field
Demonstrated expertise with GC/MS, LC/MS, HPLC and modern Data Acquisition Systems required
Knowledge and experience of GMP and related documentation skills
Strong Microsoft Office and technical writing skills for creation of procedures, protocols and reports
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivated, adaptable and possessing a positive attitude
Must be detail focused and have an exemplary work ethic