Principal Scientist / Engineer, External Tech Ops

Principal Scientist / Engineer, External Tech Ops **Why Patients Need You**Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.**What You Will Achieve**Manufacturing Sciences and Technology (MSAT) at Pfizer is looking for a highly motivated, versatile candidate to join a multidisciplinary team of scientists and engineers with responsibilities for ensuring technical success at External Contract Manufacturing Organizations (CMOs). The MSAT External Operation group supports Pfizer’s portfolio of late-stage development and commercial biopharmaceuticals being transferred and manufactured externally, and is responsible for supporting CMO assessment and selection, tech transfer, engineering/facility fit activities, as well as at scale process troubleshooting and improvements, and overall post-transfer technical oversight.We are looking for someone who is eager to contribute independent thinking, cross functional technical leadership and guidance, to join a core team of process engineers and scientists, who will partner with sending site process experts and other internal stakeholders to ensure the selected CMOs are technically set up for success. Following the successful transfer, this team would provide the ongoing primary technical oversight, campaign readiness and routine process monitoring, and support continuous process validation (CPV), process enhancement and Operational Excellence activities in partnership with the CMO.The ideal candidate should have a solid understanding and experience of upstream/downstream operations for at scale manufacturing and experience with facility and equipment qualification, validation, tech transfer, facility fit, ongoing manufacturing oversight and CPV, troubleshooting and support.As the team supports multiple CMOs in complex troubleshooting activities, it is expected that the candidate be a proficient user of problem-solving and risk analysis tools, and have a strong understanding of regulatory environment impacted by change or deviations. It is highly desirable that the candidate is a routine practitioner of the Lean/Six Sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.**How You Will Achieve It**+ Responsible for providing technical and engineering related input, oversight and ensuring schedules and milestones are set and adhered to for External/CMOs during the site assessment and selection process, tech transfers, and routine external manufacturing campaigns.+ Support sending site leads in performance of technical and risk assessments of CMO activities to ensure scientific / technical outputs are suitable for the intended use+ Ensure cross functional alignment with sending site leads, regulatory and quality on assessments, qualifications, validations and manufacturing control plans take into account PQS guidelines and current regulatory environment+ Proactively present benefit/cost analysis of technical risks and propose balanced business recommendations+ Utilize integrated resource planning tools (facility, equipment, personnel) for periods of 12 m (tactical) to 2-5 years (strategic planning).+ Foster a Continuous Improvement Mindset, with particular focus on improved tech transfer effectiveness and efficiency+ Partner with Knowledge Management Team to ensure Tech Transfer and CMO Manufacturing experience is captured and retained+ Collaborate with sending site leads and GCMC in preparation of relevant CMC sections for regulatory filing, External QA for investigations and change controls and External Supply team for timelines, schedules, and budgetary aspects+ Ensure work is executed safely at all times.**Qualifications****Must-Have**+ Bachelors degree with 12 years of relevant experience including 5 yrs in a cGMP Operational, Engineering or Site Technical Services role+ OR 9 years of experience in the biopharma industry with a Master’s degree+ OR 4 years of relevant experience in the biopharma industry with a PhD+ Experience with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry. Direct experience interacting with the regulatory authorities either through meetings at the agencies, through regulatory filings reviews, through production site-inspections or other similar circumstances.+ Proficient user of problem-solving, risk analysis and statistical tools+ Demonstrated Technology Transfers success including; facility/process fit assessments, process/Raw Material selection/qualification, cleaning/shipping validation, Equipment Commissioning and Qualification+ Familiarity with late-stage development/commercial manufacturing activities including; CPV programs, investigation processes, CAPA development, Impact Assessment,+ Demonstrated use of Operational Excellence Practices and Methodologies to improve manufacturability, cadence, COGs+ Practitioner of the six sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.+ Highly proficient in common upstream and downstream processes and experience in associated transfer and scale up+ Demonstrated record of success working in and with cross functional teams and matrix organizations**PHYSICAL/MENTAL REQUIREMENTS**Will require significant data analysis, authoring and reviewing complex technical and regulatory documents**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**+ Will likely require some out of hours working to support global transfer activities/teleconferences with other global sites and CMOs.+ Travel is expected for this role (~10-20% time)+ **Work Location Assignment:REMOTE**Last date to apply: 5/2/2023Relocation assistance may be available based on business needs and/or eligibility.**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.****Sunshine Act**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.Research and Development