Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
This position will be part of BTx Pharmaceutical Research & Development located at Andover, MA. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees.How You Will Achieve It
- Ensures 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.
- BS degree in appropriate Science & 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 & 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.
- 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 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)
Other Job Details
- 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
- Experience in Design Controls for Combinations Products
- Device Risk Management expertise
- Understand statistical sampling plan and statistical analysis of test results.
- Familiar with Human Factors Engineering - Usability Engineering.
- Understand project management methodologies and capable to provide technical leadership for projects.
- Familiar with device assembling manufacturing process
- Ability to perform mathematical calculations and ability to perform complex data analysis.
- Relocation support available
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Research and Development