ROLE SUMMARY

• Functions as a team member within India supporting the global Biotherapeutics PharmSci organization.
• Will provide support for design control projects for biologic modalities developed as combination products throughout the product and design control lifecycle.
• They will interact with cross functional development teams working with all level of employees and geographies to ensure the deliverables of the team.
• The qualified candidate will be a scientific professional with basic understanding of biologics/pharma product development seeking to lead the industry in technologies applied to advance biotechnologically derived products to the market through innovation.

• Functions as a team member and be involved in cross-functional teams across many Pfizer sites in the United States, Europe, and India.
• Ensure that combination product development (PFS, auto-injectors and pen injectors) activities are compliant with quality and regulatory standards - both internal and external.
• Responsible for supporting the planning, coordination, execution, and communication of design control activities.
• Individuals in this group will be the primary authors, reviewers, and approvers of design control documents such as design transfer checklist, risk management summary reports (including risk assessments) to support the device portfolio.
• Support in define, plan and Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support internal and external audits of the DPDD Quality System.
• Ensures resolution of issues and manages risks within project. Investigates opportunities for novel approaches to resolve issues and problems.
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel to ensure contemporary standards in authoring are met.

• About 5-10 Years of experience in Biopharmaceutical Industry/Medical Device industry with interdisciplinary drug product or combo product development knowledge.
• Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive.
• Working knowledge of EN 62366/HE75 and EU Medical Devices Regulation
• Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products
• Understanding of Design Controls for Combinations Products
• Device risk management expertise (preferred)
• Experience with biotechnology products and administration combination products such as prefilled syringes, pen injectors and auto injectors is a plus.
• Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities.