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Technology Scientist

Pfizer


Location:
Sanford, NC
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**



The incumbent works as part of a team to perform scientific and operational tasks as they relate to technology transfer and manufacturing operations. The incumbent should have the cross-functional scientific ability/skills/knowledge to work in any of the production areas including fermentation and purification. Although the incumbent may be hired to work primarily in a particular area, they are expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance projects.



The incumbent works with minimal direct supervision and is responsible for the facility design and start-up, operations troubleshooting, tracking, and reporting of a variety of manufacturing processes for the Nimenrix program. The incumbent must maintain GMP documentation essential to documenting the manufacture of commercial materials. The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.







**ROLE RESPONSIBILITIES**



Participate in efforts for the Nimenrix technical transfer from the donor sites in a technical leadership capacity. Perform technical transfer activities with minimal supervision to implement processes in the manufacturing areas. This will include leading the technical transfer of processes from the sending sites into the manufacturing areas.



The incumbent will work with internal and external colleagues to implement processes in the manufacturing facility. This includes the following:



Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. Create, edit and maintain SOPs, Master Batch Records and Compounding Records needed for new projects within the approved QA document management system. Lead the revision process of documents as they evolve during the technical transfer process. Track approval of new and revised documents through the QA document approval process. Collaborate with sending site and MSAT personnel during engineering runs to introduce the processes into the production areas through effective process technical transfer and troubleshooting activities. This includes adjusting process parameters as necessary during engineering runs and pursuit of any necessary equipment/automation refinements to ensure optimized process performance prior to demonstration runs. Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records. Provide suggestions for innovative approaches to technical transfer issues related. Incumbent must be able to recognize unique differences among different antigen processes and contribute to the scientific team that works through the issues encountered. Incumbent is aware of new process parameters co-developed with colleagues and is able to introduce them into the process. Maintain careful and accurate records of process and analytical data and findings during start-up. Utilize data and findings to contribute to meetings and make presentations on specific process issues. Provide observations/comments during schedule planning and technical transfer meetings. During demonstration and PV production campaigns, the incumbent will function as the process subject matter expert and will execute batch production and provide leadership to the manufacturing teams. The incumbent will also perform real-time troubleshooting of equipment and process operations to ensure successful batch completion. Maintain equipment and automation proficiency. Execute equipment preparation and operation in controlled and classified areas. Utilize colleagues and available resources/literature to solve complex problems with input from site colleagues as needed. Operate the following types of process equipment: fermentors, recovery equipment, ultrafiltration/diafiltration skids, depth filtration equipment, chromatography columns, fixed and portable vessels, vacuum dryers, and cleaning equipment. Submit samples to QC and enter sample information into the approved quality laboratory information management system.



Procure, test, and operate equipment and computer controls within the production areas. This will include the following:



Gain expertise on existing processes in order to successfully transfer and produce the Nimenrix intermediates. Understand the progress to date in conceptual and detailed facility design, equipment design and procurement, and computer control system design and review. Ability to read P&ID diagrams and compare with as-built field construction. Contribute to resolution of outstanding detailed design and logistics issues in order to prepare for smooth commissioning, validation, and start-up of the facility, equipment, and control systems. Work with project teams to operate and commission the equipment. Perform equipment evaluation with vendors and project engineers during commissioning testing. Research and find new technology or alternate specifications as needed for resolution of installation/commissioning issues. Identify and resolve any operating issues that exist with the equipment during execution of operational qualification protocols in order to ensure flexible, efficient, and compliant use of the equipment. Analyze and interpret any equipment operational results independently. Contribute to design of equipment/operation in consultation with site colleagues. Utilize detailed understanding of processes, equipment, facility, and distributed control system and cGMP compliance in order to write SOPs for functional area and general procedures. Facilitate review, approval, and implementation of these new SOPs.



Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the manufacturing department. Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities. Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.







**QUALIFICATIONS**



A minimum of a BS degree in either of the following discipline: chemistry, biochemistry, biotechnology, chemical engineering or equivalent science related field or engineering discipline. Four to 7 years of experience; or equivalent combination of education and experience is required for this position.



Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes. Unit operations that include fermentation, centrifugation, ultrafiltration, depth filtration, column chromatography, and dispensing operations. Experience in automation including DeltaV and equipment validation is desired. Direct knowledge and experience in manufacturing execution and tech transfer within a Biopharmaceutical/pharmaceutical cGMP environment.Direct knowledge and experience in manufacturing execution and tech transfer within a biopharmaceutical/pharmaceutical cGMP environment.







**PHYSICAL/MENTAL REQUIREMENTS**



Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm.







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



It will be necessary to work shifts according to the manufacturing schedules (1st, 2nd or 3rd shift) to support batch production.







**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: 10 November, 2017**



+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 007**







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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