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Drug Substance Process Scientist
1 month ago
This is a hybrid working role.
Process Scientist Technical Services Technical Services works to anticipate and deliver on the process technology needs of the business, including technical transfers, process and cleaning validation, process optimization, and major investigation support.
This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the following areas at Pfizer Grange Castle.
Drug Substance Proteins Drug Substance Vaccines Bioprocessing The jobholder works within the Technical Services teams and requires the flexibility to move from one project quickly or to work on multiple smaller projects at the same time.
*Key member of the tech transfer team, working within site Technical Services supporting the transfers of new products and representing the site at key internal and external tech transfer meetings.
*Capture all aspects of the existing process and equipment to ensure that an equivalent process is transferred to Grange Castle.
*Technology Transfer, including Gap Analysis, Process Transfer Risk Assessment, process description, new material introduction support etc.
*Execute requisite process trials to facilitate transfer as required.
*Develop process validation protocols and lead their execution in conjunction with Operations.
*Generate process validation summary reports and associated filing submissions.
*Ensure the process automation meets the requirements of the process.
*Liaise with site functions logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC.
*Lead major process investigations as requested and support the implementation of CAPAs.
*Provide technical training on process and technology areas as required by the project.
*Provide independent decision making for strategic input into the facility & equipment design, support site operational readiness (equipment, process understanding etc.).
*Deliver presentations thatdistilcomplex ideas and proactively communicate results and progress to technical teams, management, and business leadership.
*Support Compliance Inspections and enquiries from Regulatory Agencies.
*Provide technical oversight of routine process monitoring and follow-up on any significant adverse trends.
*Perform Continuous Processing Monitoring (CPV) on commercial processes.
Requirements *Minimum of 2 5 years experience working in a cell culture manufacturing process; upstream / downstream process development or technical transfer of a drug substance process to a large-scale biotech manufacturing facility.
*Knowledge of technical transferprinciples.
*Demonstrated aptitude for technical learning and problem solving.
*Strong background in mammalian cell culture, protein purification or validation.
*Experience of FDA and EU licensing and inspection supportisdesirable *Knowledge of single use systems and new material introduction Skills: Demonstrated technical capability and aptitude for technical learning.
Strong evidence of problem-solving/trouble-shooting skills.
Ability to independently plan and perform work assignments, interpret and present data.
Capability of working in a multi-disciplinary team environment.
Strong interpersonal skills with an ability to work independently across sites and teams.
Highly motivated, proactive, and persistent.
Effective communication (verbal, written).
Skills: Drug Substance Proteins Drug Substance Vaccines Bioprocessing
