Overview In this role you drive the selection, qualification, and lifecycle management of materials used in biologics development and manufacturing. You will lead risk-based material assessments and collaborate across drug development, manufacturing, quality, regulatory, and supply chain teams to safeguard product quality and patient safety. Your work supports technology transfer, supplier changes, and regulatory readiness, shaping material strategies and documentation. This role offers meaningful impact on process performance and supply continuity in a global biotech setting. You'll engage with cross-functional partners to deliver evidence-based material decisions and robust data foundations.
Compensation / Benefits- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- medical, dental, vision, and life insurance
- opportunity for career development and growth
- competitive compensation
Responsibilities- Provide leadership for material selection, qualification, characterization, and lifecycle management of product-contact materials used in biologics.
- Lead phase-appropriate material risk assessments and define requirements, attributes, specifications, and testing strategies to protect process performance and product quality.
- Drive qualification activities from need identification to supplier qualification, GMP implementation, and lifecycle monitoring with complete documentation.
- Lead or support extractables/leachables assessments, chemical compatibility evaluations, supplier-document reviews, and single-use system reviews; produce risk assessments and technical reports.
- Assess supplier-initiated material and process changes using science- and risk-based approaches and define data and controls.
- Partner with cross-functional teams to make evidence-based material and supplier decisions.
- Support business continuity and technology transfer by evaluating alternate materials or suppliers and mitigation strategies.
- Contribute technical input for due diligence, supplier audits, change controls, process validation, and regulatory submissions; address health-authority questions.
- Plan and execute laboratory or external testing to understand material variability and connect material attributes to process performance and product quality.
- Develop standards, templates, databases, and knowledge-management tools for consistent material controls and data reuse.
Key requirements- PhD with 2+ years of relevant experience, or MS with 6+ years, or BS with 8+ years in a related field.
- Experience supporting biologics development, technology transfer, or manufacturing in a regulated biopharmaceutical environment.
- Expertise with material categories such as process chemicals, media, excipients, resins, filters, single-use systems, or primary packaging.
- Working knowledge of material characterization, specifications, supplier documentation, risk assessment, change management, and GMP expectations.
- Ability to lead complex technical work independently, manage multiple priorities, and communicate decisions across functions.
- excellent communication
- collaboration
- influencing across stakeholders
- material characterization
- extractables and leachables
- chemical compatibility
