Associate Manager II – BTxPS Design Control Support Lead

2 weeks ago


Chennai, Tamil Nadu, India Pfizer Full time

At Pfizer, we are seeking a highly skilled Associate Manager II to join our BTx Pharmaceutical Research & Development team. As a key member of our organization, you will be responsible for leading design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle.

Key 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.
Qualifications:
  • Preferred Education: BS degree in appropriate Science/Pharmacy/Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 4-6 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
  • OR MS degree in appropriate Science/Pharmacy/Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 3-5 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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