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Manufacturing Scientist

Pfizer


Location:
Sanford, NC
Date:
02/09/2018
2018-02-092018-03-12
Pfizer
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Job Details

**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 p rovide 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 day's 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 biotherapeutics. The incumbent is knowledgable 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 understaning 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 SOP's, 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 four to seven years of experience in a FDA regulated industry.



Four to seven years of 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.







**PHYSICAL/MENTAL REQUIREMENTS**



Capable of sitting and/or standing for extended periods of time during the work shift







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



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







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Last Date to Apply for Job:** 22 February, 2018







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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