MSAT Subject Matter Expert
What You Will Achieve
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 including project management and team leadership for aseptic drug products, including co-development, technical transfer, scale-up, process validation, registrations, ongoing troubleshooting and process improvements.
This position specifically involves leading and managing the technical and development activities for product transfers to and from the Pfizer network and contract manufacturing organizations (CMOs). Identification, development, and implementation improvements of manufacturing processes for new and existing sterile injectables products across all business units, and manufacturing site support for critical investigations.
A primary focus of this position will be around the support of specific Liquid Nano Particle (LNP) production process, including day-to-day plant technical support, driving continuous improvement initiatives, and participating in processing engineering activities for capital projects.
How You Will Achieve It
As a MSAT Subject Matter Expert your responsibilities could include:
Providing technical subject matter expertise and team leadership for major/moderately complex investigations for aseptic sterile injectables, biologics and vaccines and assisting in completing all required documentation in a timely manner. Including implementation of CAPAs. Specifically, for LNP based products
Leading Drug Product Tech Teams
Ensure resolution of technical issues to sustain a consistent supply of product to the market.
Leads cost reduction projects
Work with sites to implement product changes
Serve as product Subject Matter Expert for Regulatory submissions/renewals
Preparing, reviewing, and approving 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 Leading moderately complex projects. Project scope may not be clearly defined
Maintaining project updates in IMEx Visual Management Board (VMB) and other methods, as requested
Good influencing skills and ability to work in a matrix organization to deliver results
Comfortable with multifunctional and multi-cultural environments
Effective influencer, motivator and communicator
Strong analytical, strategic and interpersonal skills.
Ability to synthesize concepts and requirements and effectively communicate them to all PGS stakeholders
Interfacing with and influencing diverse customers including site groups from PGS (Ops, Technical Services, Quality) and network groups such as External Supply, QA,PharmSci, Procurement, and GCMC
Approach / Mindset
Recognizes cross-functional impact in all decision-making; proactively reaches out to external stakeholder groups to gain alignment on cross-functional issues
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 in problem solving
Knows when to report or escalate risks and issues to leadership
Use of DMAIC principals 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 5+ years or Masters with minimum 3+ years in Engineering (Mechanical, Chemical, or Pharmaceutical preferred) or Life Sciences Experience
Operations or Tech services experience
Experience with Tangential Flow Filtration
Strong communication skills and attention to details.
Demonstrated ability to lead small product change projects with small multi-discipline teams
Excellent technical writing skills.
Excellent problem-solving skills
Experience with Liquid Nano Particles strongly preferred
Experience with lyophilization is an advantage
Black Belt or Green Belt experience is an advantage
Ability to think creatively and find innovative solutions is a plus
Strong knowledge of MS Word, Powerpoint, Excel; Working knowledge of Minitab or JMP preferred
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 zones
Other Job Details
- Last Date to Apply: May 25, 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