Biologics Design Control Expert
3 weeks ago
About the Role
This is an exciting opportunity to join Pfizer as a Biologics Design Control Expert, where you will play a crucial role in supporting the global locations of BTx Pharmaceutical Research & Development. Reporting within the India GRS organization, you will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.
Job Responsibilities
- 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.
- Author documents that will be a part of the Design History File.
- 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
To succeed in this role, you will need:
- Bachelor's or Master's degree in a relevant science or engineering discipline, such as chemistry, biochemistry, biomedical engineering, mechanical engineering, materials engineering, or chemical engineering.
- A minimum of 3-5 years of experience in the pharmaceutical combination product and/or device industries, with a strong background in design control and risk management.
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, and the EU Medical Devices Directive.
- Experience in design controls for combination products, device risk management, and statistical sampling plans.
- Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
What We Offer
Pfizer offers a competitive salary of $120,000 - $180,000 per annum, depending on experience, as well as a range of benefits, including health insurance, retirement savings plan, and paid time off.
Location
The successful candidate will be based in a flexible location, with opportunities to work remotely.
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