Senior Scientist, Raw Materials (US-PA-Philadelphia)
The Senior Scientist, Raw Materials is responsible for refining the raw materials control strategy for WuXi AppTec Philadelphia Manufacturing. This individual will be responsible for providing regulatory and scientific guidance for Manufacturing, Supply Chain Quality, and Raw Material Testing activities. The Senior Biologics Material Scientist will also be responsible for supporting quality assurance to ensure compliance with FDA regulations and Company strategies supporting the raw materials program, specifically. This individual will also serve as the subject matter expert with respect to all aspects of the raw material program, will participate in regulatory audits, and provide technical support on vendor quality audits, as needed. This position also may have responsibility for the development of assays relating to raw material release, when needed. Overall, the new hire will work with the Technical, Quality, Regulatory and Supply Chain organizations to ensure that our products meet the highest quality standards.
Works closely with Manufacturing clients to develop individual raw material control strategies.
Defines risk tolerance and risk strategies for the raw materials supply and release program for the Manufacturing programs at the Philadelphia location.
Takes a leadership role in defining appropriate test methods/testing strategy for raw materials.
Evaluates and defines whether client raw materials are appropriate for the clinical phase of the biological product.
Serves as a key member of the Material Review Board (MRB).
Works closely with Supply Chain and the MRB to review supplier change notifications and other items related to raw materials.
Assures all activities in the area of raw materials meet cGMPs, FDA and International regulatory requirements.
Prepare, own and revise SOPs relevant to the site raw material control strategy.
Participates in PAIs, regulatory and quality audits, as needed.
Participates, as needed, in evaluating supplier quality including vendor site visits.
Assists, as needed, in writing CMC sections for raw materials.
Develop and qualify assays for the release testing program when needed.
Ph.D. with a minimum of 5 years experience in pharmaceutical organizations preferably in a quality, regulatory, or QC role related to raw material release.
Thorough knowledge and experience with GMP a must. li knowledge of USP, FDA regulatory guidance documents, EU regulations and ICH guidelines.
Working knowledge of regulatory and quality raw material requirements for Phase 1 through post approval, including the associated change management and reporting.
Familiarity with US and EU regulations for Cell and Gene Therapy products and raw materials.
Assay development experience.
li oral and written communication skills. li organizational skills with the ability to multi-task and prioritize assignments. Ability to write reports, meeting agendas/minutes, business correspondence, and procedures such as SOPs.
Excellent critical thinking and problem solving abilities.
Ability to effectively manage multiple projects under short time lines.
Ability to work under pressure and effectively lead in a fast-paced, dynamic technical environment.
Ability to be flexible and work in cross-functional teams.
Working knowledge of Microsoft suite of software products including Excel, Word and PowerPoint.