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NPI Operations Specialist

Pfizer


Location:
Dublin, OH
Date:
12/23/2017
2017-12-232018-01-23
Pfizer
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Job Details

Closing date for applicants: 15th January 2018







**J** **ob Purpose:**



Act as an SME for Upstream or Downstream Operations related aspects of both project and routine manufacturing operations working in conjunction with a team of operations personnel. For project related activities focus will initially through detailed design & procurement and subsequently construction, commissioning, verification/qualification, PV and start-up. For routine manufacturing This role focuses on leading and resolving technical issues within the Operations Unit, including process/equipment troubleshooting, investigating deviations, identification and implementation of CAPAs and process improvements.







**Reporting Structure:**



**NPI Operations** **Lead**



****



**NPI Operations Specialists**







**Responsibilities:**







+ Define Operations project team requirements and work with the sustaining ops leadership to put this team in place (Pfizer colleagues/direct contract resources).



+ Provide operation input into definition of scope and requirements for equipment and facility layout in the first phase of investment taking into account future capability for new products, based on Pfizer's platform process technology for MAbs derived from mammalian cell culture.



+ Lead and participate in Commissioning, Validation and Verification execution and trouble shoot technical issues.



+ Responsible for SOP and batch record/ EBR creation; training plan creation and training execution.



+ Provide expertise and insight to ensure that facility design enables safe and efficient operation and rapid product changeover to maximize facility utilization.



+ Contributes to long range plans.



+ Strategically analyses the risks, benefits, and opportunities of various solutions to technical and operational issues



+ Co-ordinate cross-functional activities to ensure completion



+ Support Sustaining Operations in a day-to-day capacity Provide routine process technical support, trouble-shooting and resolution of manufacturing process and technology issues



+ to ensure the successful completion and disposition of batches in a timely manner



+ Support Compliance Inspections and enquiries from Regulatory Agencies.



+ Be competent with Quality Systems, including Manufacturing Investigations, Change Controls and Commitments and Maintenance systems.



+ Be competent in developing Technical/ product/process impact assessments in support of investigation closures.



+ Experience writing technical documents, including SOPs, batch records that describe protein manufacturing unit operations and processes.



+ Deliver presentations that distill complex ideas and proactively communicate results and progress to technical teams, management, and business leadership.







**Education/Experience:** Educational Requirements:







+ Minimum qualification of a B. Sc. Degree in Bioprocess Science, Engineering, Biotechnology or equivalent with a preference for Biochemical, Chemical or Biological disciplines.







Minimum Experience:







+ 7+ years biopharmaceutical manufacturing experience in a technical role.



+ In depth working knowledge of upstream and or downstream processes within mammalian cell culture manufacturing including all key processing parameters and their effect on Yield.



+ Hands on knowledge changes control and documentation systems.



+ Hands on knowledge of commissioning/validation/verification execution



+ Experience or aptitude in leading and managing project work/teams



+ Experience of leading and participating in FDA and EU licensing inspections.



+ Demonstrated ability to provide technical solutions for complex problems through product/process knowledge.



+ Experience with shake-flask culture, commercial scale bioreactor operation and harvest operations, aseptic technique working on mammalian cell culture processes would be advantageous.



+ Experience in commercial scale downstream process biopharmaceutical protein production would be advantageous.



+ Experience in buffer and media preparation and equipment cleaning is desirable.



+ Knowledgeable in protein biochemistry and analytical methods relevant to protein purification



+ Knowledgeable in protein biochemistry and analytical methods relevant to protein purification



+ Demonstrated ability to provide technical solutions for complex problems through product/process knowledge.







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