MSAT Subject Matter Expert (4844905_Rocky_Mount)
The individual selected will be a key part of the Sterile Injectables Manufacturing Science and Technology Group which delivers science-based solutions every day for every patient. The primary function is to implement the solutions that address the most critical business challenges in Global Sterile Injectables and Biotech. In scope is full product life cycle support for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting, and process improvements.What You Will Achieve
This position specifically involves supporting tech transfers to the Pfizer network and contract manufacturing organizations (CMOS), evaluating new and innovative technology, developing/improving processes for new and existing products, and participating in critical investigationsHow you Will Achieve It
A primary focus of this position will be around the support of specific Liquid Nano Particle (LNP) production processes, including day-to-day plant technical support, driving continuous improvement initiatives, and participating in processing engineering activities for capital projects.
As a MSAT Subject Matter Expert your responsibilities could include:
- Serve as the technical owner of products or product technologies and provide SME support for product issues or product questions. Specifically, for LNP based products
- Ensure resolution of technical issues to sustain a consistent supplyproductsduct to the market.
- Serving as technical SME on product investigations
- Participate on projects to reduce costs.
- Work with sites to implement product changes
- Serve as product Subject Matter Expert for Regulatory submissions/renewals
- Preparing, reviewing, and may approve documents including protocols, reports, technical assessments, memos, study plans, and meeting minutes, as needed
- Collaborating with wet and analytical labs to execute exploratory or feasibility studies
- Contributing to and occasionally managing projects with a clearly defined scope
- Maintaining project updates in IMEx Visual Management Board (VMB) and other methods, as requested
- Comfortable with multifunctional and multi-cultural environments
Approach / Mindset
- Able to identify root causes and drive to problem resolution; orientation towards action - anticipates problems and acts proactively to resolve; demonstrated initiative, drive, and creativity inproblem-solvingg
- Knows when to report or escalate risks and issues to leadership
- Use of DMAIC principles to drive resolution of issues and drive improvement of supplier performance
- Embraces Pfizer Purpose: Breakthroughs that change patients’ lives through the incorporation of Pfizer’s Bold Moves and Values
- BS with minimum of 3+ years or Masters with minimum of 1+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
- Experience with Liquid Nano Particles preferred
- Experience with Tangential Flow Filtration preferred
- Strong communication skills and attention to detail.
- Demonstrated ability to lead small product change projects with small multi-discipline teams
- Strong technical writing skills.
- Strong problem-solving skills
- Strong knowledge of MS Word, Powerpoint, Excel; Working knowledge of Minitab or JMP preferred
- Ability to think creatively and find innovative solutions is a plus
Ability to be on the production floor during engineering/development batches
NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS
Global travel may be required, typically 15-25%.
Adaptation of work schedule to accommodate meetings with colleagues in different time zonesAdditional information
- Last date to apply- 4/20/2022
Pfizer 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.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
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.Engineering#LI-PFE