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The Ritedose Corporation · 4 days ago

Sr./Principal Scientist - Extractables & Leachables

Columbia, SC

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

The Ritedose Corporation is seeking a Sr./Principal Scientist specializing in Extractables and Leachables testing. The role involves managing the E&L program, overseeing analytical methods development, and ensuring compliance with regulatory requirements while leading project teams.

ManufacturingPharmaceutical

Growth Opportunities

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

Qualification

Extractable/Leachable expertiseGC/MSHPLCGMP knowledgeTechnical writingLeadership abilitiesCommunication skillsAttention to detailTeamworkSelf-motivated

Required

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