• Tech Specialist, Clinical Manufacturing, Fermentation Jobs in United States Of America

  • Pfizer Inc.
  • United States Of America, Usa
  • Save Job
  • 1 - 3 Years
  • Posted : above 1 month

Job Description:

ROLE SUMMARY

The clinical manufacturing Technical Specialist is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio

At Pfizer, we innovate every day to make the world a healthier place It was the vision of Pfizer at the very beginning and it holds true today in everything we do From scientific discovery to breakthrough products to our essential partnerships around the world, were committed to quality healthcare for everyone Because every individual matters Our medicines and vaccines save or improve countless lives and our consumer products empower people to take care of themselves Pfizer Corporate Responsibility believes that all individuals, everywhere, deserve access to quality healthcare and the opportunity to lead healthy lives

Diversity, equality, and inclusion are an integral component of Pfizers mission to build a vibrant culture We maintain the highest standards of ethics and compliance in all of our business practices

This Technical will coordinate and lead production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations

The initial focus of this role will be part of the Fermentation suite startup team to prepare the facility for operational readiness This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, batch records, and standard work May also include commissioning and qualification of process equipment Post full facility start up, the successful candidate will transition to 2nd shift to be part of a team that will be responsible for the execution of microbial upstream and downstream processes

ROLE RESPONSIBILITIES

Execute primarily upstream and downstream microbial fermentation processes in a cGMP environment Includes CIP and SIP operations and preparation or ancillary activities Support fellow mammalian teams as opportunities arise
Comply with cGMP regulatory standards, SOPs, and Batch Records for generation of the highest quality drug substance material
Ensure all safety and compliance procedures are followed at all times, and continuously work to improve the safety culture
Actively maintain inter-team, cross-shift, and cross -functional communication to accomplish shared objectives
Engage in Pfizers Purpose Blueprint and identify and/or supports continuous improvement initiatives Actively contribute to making Pfizer a great place to work
Provide support for troubleshooting, general technical support, and resolution of equipment, automation, and process issues on the manufacturing floor
Contribute to the continuous improvement of controlled documentation (SOPs, Manufacturing Procedures (MPs)
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk
Effectively uses process automation systems (ie Delta V and OSI/Pi Historian) and supporting business systems (ie Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc)

BASIC QUALIFICATIONS

HS diploma, Associates Degree, or BS/BA in scientific or engineering-related discipline
Requires a minimum 1-3 years of experience in a biotechnology manufacturing or laboratory environment

PREFERRED QUALIFICATIONS

Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting a plus
Prior experience in cell culture and/or microbial fermentation, harvest, chromatography and TFF processes
Experience with Production Control Systems (ie DeltaV), ERP Systems (ie Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc)
Experience with Quality Management and Change Management Systems (ie Trackwise)
Demonstrated ability to follow Standard Operating Procedures and work under minimal supervision
Strong mechanical aptitude and ability to interface with computerized systems required
Demonstrated capability to work as a team member in a manufacturing team
Excellent verbal and written communication skills

PHYSICAL/MENTAL REQUIREMENTS

Must be able to climb flights of stairs and be standing for ~1-2 hours at a time
Must be able to lift up to 25lb
Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This is a 2nd shift position, however during commissioning and start up, the candidate will work 1st shift hours Once the facility is fully operational, the candidate will transition to 2nd shift
Ability to work day shift (Occasional Weekends) as needed; non-routine
Ability to work in a clean room environment

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 13th Feb 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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