• Manufacturing Scientist Jobs in United States Of America

  • Pfizer Inc.
  • United States Of America, Usa

Job Description:

ROLE SUMMARY

The incumbent will be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc) and their primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations The incumbent will assist with production planning and provide / support coordinating production activities across Fermentation, Purification, and Conjugation working with the Clinical Manufacturing Team Leads and Process Engineers The incumbent will provide training for operational qualifications and assist the Team Lead and Process Engineer in assuring all personnel are appropriately trained for the applicable tasks

The incumbent provides process execution and equipment operational activities in support of cGMP clinical and /or commercial manufacturing Provides organizing role to ensure appropriate scheduling of activities and ensure production supplies are available for the days operations The incumbent works directly with the Clinical Manufacturing Team Leads and Process Engineers in the resolution of issues for Bioprocessing Technicians to fulfill manufacturing requirements during the shift of operation

Conducts all activities that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc Advise management of non-conformance issues and opportunities for continuous improvement

ROLE RESPONSIBILITIES

The incumbent is a skilled manufacturing scientist with knowledge of microbial fermentation, purification, and conjugation processes in the production of microbial vaccines and bio therapeutics The incumbent is knowledgeable of required processing unit operations and control systems needed for operations The incumbent works as part of the production team and leads as well as performs scientific and operational tasks related to clinical manufacturing The incumbent will work in support of 24 hour operations working in various shifts Job responsibilities include

This position acts as production area shift lead working in a team environment with Bioprocessing Technicians and Clinical Manufacturing Scientists to execute processing and operational activities in support of manufacturing Requires detailed knowledge of the operational aspects for Fermentation, Purification, and Conjugation processing to organize daily functions and work in concert with Bioprocessing Technicians in executing those functions in a compliant, safe and efficient manner to maintain production schedules Must be capable of assessing challenges to the schedule and re-directing activities as necessary to minimize impact to quality, compliance and timelines Must be capable of making real time cGMP critical decisions in the absence of the Clinical Manufacturing Team Lead &/or Process Engineer, assuming responsibility of approving critical processing steps and trouble shooting equipment
In addition to processing, cleaning, and operating major process equipment (tanks, fermentors, ultrafiltration units, lyophilizers, etc), job duties also include routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers, autoclaves and depyrogenation ovens, use calibrated scales to weigh out dry components and use graduates and flasks to measure liquids Also, performs laboratory activities such as performing sample dilutions, pH, and conductivity readings
Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on microbial fermentation / purification and conjugation processing
Capable of detecting technical problems and assisting the appropriate colleagues for resolution Ability to collect and assemble applicable, vital information for presentation to CM Team Leads and/or Manufacturing Process Engineers to assist in troubleshooting and decision making
Provides input and revises SOPs, batch records, forms or other cGMP related documents developed or revised to support continous improvement efforts, investigation corrective actions, manufacturing operations, automation control (PLC, DeltaV, etc) and regulatory audit commitments

May be required to attend meetings of major capital or process improvement teams, eg facility expansion, technology transfer, MES implementation, operational efficiency, etc

QUALIFICATIONS

BS degree with two or more years of experience in a FDA regulated industry

Prefer experience within the biopharmaceutical industry, including knowledge and experience with relevant biopharmaceutical unit operations and/or laboratory operations Experience should include operational and troubleshooting skills for biopharmaceutical processing equipment and/or analytical instrumentation

Applicable skills and qualifications to perform daily operational tasks and lead/assist with shift activity scheduling

PHYSICAL/MENTAL REQUIREMENTS

Capable of sitting and/or standing for extended periods of time during the work shift, as well as, ladder climbing, repetitive bending, pushing, and lifting (up to 40 lbs)

NON-ROUTINE WORK SCHEDULE/TRAVEL REQUIREMENTS

Must be able to work a rotating shift schedule to support a 24 hour manufacturing operation

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 : 18th Mar 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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