ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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

• 10+ years of experience in the biopharma industry with at least 5+ years in an cGMP Operational, Engineering or Site Technical Services role

• 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

Behavioral attributes

• Consultative and collaborative, with a self-assured bias towards decision making and action when circumstances demand.

• Gains satisfaction from coaching, leading, mentoring and influencing the development and progress of others.

• Highly motivated with a drive towards technical achievements of self and team. 

• Excellent Korean & English communication skills (verbal + written). 

• Ability to matrix-work effortlessly across team and organizational / hierarchical boundaries

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: This is a remote work position and requires occasional visit to vendor site located in Incheon.

Application Deadline: April 3 (Mon), 2023 6:00 pm

Please apply via Pfizer Career Website Only and upload both English & Korean resumes when applying for the position.

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