Material Scientist: Polymer & Biocompatibility SME
Listed on 2026-09-03
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Engineering
Process Engineer, Materials Engineering, Chemical Engineering, Regulatory Compliance Specialist
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 bio reactivity (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
- 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
- 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 selection decisions for new single-use system designs and primary packaging solutions, ensuring alignment with processing requirements, regulatory expectations, and sustainability objectives.
- 3. Participate in industry forums to continuously benchmark industry updates and align Pfizer strategy and to influence at an industry level.
- 4. Maintain project status in digital systems or other methods, as requested
- 1. Recognizes cross-functional impact in all decision-making; proactively reaches out to stakeholder groups to gain alignment on cross-functional issues
- 2. Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity in problem solving
- 3. Knows when to report or elevate risks and issues to…
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