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About the role
- Lead design control projects for biologics modalities developed as prefilled syringe-based combination products. Ensure compliance with quality and regulatory standards during the product lifecycle.
Responsibilities
- Lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle
- Ensure that combination product development activities are compliant with quality and regulatory standards – both internal and external
- 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
- Provide input and support for design validation, including but not limited to human factors engineering assessments
- Support the generation of all regulatory submission data and content for assigned device projects
- Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply
- 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
Requirements
- BS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 3+ years of relevant experience in the Pharmaceutical Combination Product and/or Device industries
- OR MS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 0+ years of relevant experience in the Pharmaceutical Combination Product and/or Device industries
- 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 and EU Medical Devices Regulation
- Capable of working independently with minimal supervision
- High level of attention to technical details and accuracy
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
- Able to work collaboratively in cross functional teams
- Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills
- Proficiency in general computer software such as word processing, spreadsheets, presentations
- Understand Good Manufacturing Practices (GMP)
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental leave
- Paid medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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