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, PharmSci, 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 NetZero and chemicals of concern goals.
2. Provide expert guidance on material safety compliance and strategy including bioreactivity (USP <87>, <88>, ISO 10993) and physicochemical testing ( <661>, <665>, <381>, <383>, 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, PharmSci, 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
Approach and Mindset
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 escalate risks and issues to leadership
4. Embraces Pfizer Purpose: Breakthroughs that change patients' lives through the incorporation of the Bold Moves and Values and Behaviour's
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment :Onsite
This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.
Additional Information
How to apply
Purpose
Breakthroughs that change patients' lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Tagged as: Life Sciences
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