"Alerted.org

Job Description:

The incumbent will be an expert in the field of Extractable and Leachable (E&L) testing who will be responsible for managing the E&L program at Ritedose. The position requires in-depth knowledge of applicable 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 position also requires a background in the usage of in silico evaluation and toxicological assessment of determined leachates. The incumbent will have expertise in testing for E&L using various analytical methods such as HPLC/UV, HPLC/MS, GC/MS, and ICP-MS, as well excellent leadership and communication skills as required for Ritedose CDMO activities.

Responsibilities:

+ 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.

+ Possess 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 to derive 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 GDPs.

+ Responsible for writing laboratory SOPs, studies, protocols, and reports.

+ Assist in regulatory audits.

+ Lead OOS and deviation investigations.

Qualifications

Qualifications:

+ BS in Chemistry or related science with a minimum of 15 years’ experience; preferably MS with 13 or Ph.D. with 10 years’ experience working in the pharmaceutical industry in the Extractable/Leachable area

+ 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

+ Demonstrated leadership abilities

+ 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