Material Scientist: Polymer & Biocompatibility SME

Position: Material Scientist: Polymer & Biocompatibility SME
Job Summary This position serves as the polymer and biocompatibility material science subject matter expert for single-use systems, primary packaging, and polymeric components used across drug substance, sterile drug product manufacturing, and biopharmaceutical processing. The role provides strategic and technical leadership for material safety assessments, polymer qualification strategies, regulatory support, and risk-based decision-making to ensure materials are suitable, compliant, and scientifically defensible for use across Pfizer’s manufacturing network.

The position is accountable for advancing material safety compliance, supporting regulatory submissions, evaluating new and modified polymer solutions, and enabling sustainability and chemicals-of-concern initiatives, including alternative polymers, reduced-additive formulations, and future-ready material platforms. The role translates compendial standards, regulatory expectations, industry guidance, and material characterization data into actionable recommendations that support product quality, patient safety, supplier qualification, and network-wide adoption of new technologies.

Working with a high degree of technical independence and cross-functional collaboration, this individual partners with PGS sites, Pharm Sci, Quality, Regulatory Affairs, Procurement, Operations, suppliers, and industry forums to resolve complex material challenges, influence standards, and support digital knowledge-management solutions that improve material selection, qualification efficiency, and enterprise decision-making.

Job Responsibilities Technical & Strategic Leadership
1. Lead material science strategy for single-use systems across biopharma and sterile drug product manufacturing and packaging, collaborating with leadership to establish direction for polymer selection, qualification, and risk mitigation aligned with Net Zero and chemicals of concern goals.
2. Provide expert guidance on material safety compliance and strategy including bioreactivity (USP , , ISO 10993) and physicochemical testing ( , , , , EP 3.1) to demonstrate material safety for pharmaceutical manufacturing applications.
3. Independently coordinate and oversee material characterization and safety testing programs for new and modified polymeric materials used in single-use assemblies, determining technical scope, establishing project timelines and cost estimates.
4. Translate compendia standards (USP, Ph. Eur., ISO), industry guidelines (Biophorum, ASTM, BPSA), and regulatory requirements into actionable Pfizer processes and specifications for polymer material qualification.
5. Evaluate and identify qualification strategy for emerging polymers and alternative materials to meet evolving biopharma processing requirements (e.g., bio-based resins, mass-balance polymers) while addressing future chemicals of concern regulations including Nitrosamines, BPA, and PFAS restrictions.
6. Provide necessary technical inputs to develop AI and Digital solutions to enable enterprise process simplification Knowledge and Skills
1. Generate technical protocols, reports, and material assessments demonstrating strong material background, technical writing skills and ability to communicate complex material science concepts to diverse audiences.
2. Maintain and expand polymer material databases and knowledge management systems to support global material selection, supplier qualification, and regulatory compliance across the single-use network.
3. Monitor and assess industry trends in polymer technology, sustainability innovations, and emerging regulatory requirements; proactively develop strategies to address materials challenges and opportunities.
4. Interprets internal/external technical challenges and best practices to recommend improvements to products, processes, or services Collaboration
1. Collaborate effectively across multiple PGS sites, Pharm Sci, Quality, Regulatory Affairs, Procurement, Operations, and external suppliers to provide material science recommendations and risk assessments for complex, multi-variable qualification programs.
2. Support cross-functional design teams in material…