Pfizer Gene Therapy Process Engineer in Sanford, North Carolina
The incumbent works as part of a GTx team to perform scientific and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support. The incumbent should have the cross-functional scientific ability/skills/knowledge to support the GTX production areas including Solution Prep and Drug Substance Operations. The incumbent will initially focus on supporting start up of the Solution Prep GTx Stage 2 area but is expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects.
The incumbent works with some direct supervision and is responsible for the supporting the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of manufacturing processes for clinical and launch campaigns of GTx products. The incumbent must comply with applicable safety, occupational health, loss prevention and environmental requirements.
Participate in start up of the Stage 2 Solution Prep and support Operational Readiness of this area in a technical capacity.Perform technical transfer and process engineering activities by working with senior level colleagues and supervision to implement processes in the manufacturing areas.This may include assisting in technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technical transfer from clinical to commercial facilities. Provide process engineering knowledge in process design from initial design specifications through implementation including testing during engineering projects. Collaborating with the Site, Engineering & Maintenance (SEM) department and outside engineering firm personnel will be critical to successful outcomes. Assist in developing new process procedures (i.e. CIP/SIP paths, WFI flush, blowdown, waste removal, stat paths) and review closely with SEM automation team and Technical Operations team. Perform calculations to ensure correct equipment sizes are in place for new processes. Assist in procuring process equipment. Develop process flow diagrams for illustrating critical process and material flow. Review, recommend and execute process improvements and optimizations to existing processes with engineering principles (i.e. SIP/CIP optimization, cycle time reduction, equipment efficiency, PAT).Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions.Develops guides and executes implementation of solutions to complex process engineering problems. 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 processes within the approved QA document management system.Lead the revision process of documents as they evolve during the technical transfer and development process.Track approval of new and revised documents through the QA document approval process. Collaborate with development personnel during engineering practice runs to introduce a variety of product candidate processes into clinical production areas through effective process scale-up 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 scale-up issues related to new projects. Maintain careful and accurate records of process and analytical data and findings on development projects.Utilize data and findings to contribute to meetings and make presentations on specific process issues.Provide observations/comments during schedule planning and process development meetings.During demonstration and clinical 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 to ensure successful batch completion.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to manufacturing. 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.
• 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. Minimum 5 years of experience; or equivalent combination of education and experience is required for this position.
• Knowledge of the manufacturing process and equipment, preferably solution prep and Drug Substance upstream and downstream unit operations
• Experience with designing technical studies, authoring technical protocols and reports
• Direct knowledge and experience in manufacturing execution and tech transfer within a biopharmaceutical/pharmaceutical cGMP environment.
• Experience in automation including DeltaV and equipment validation is a plus
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.
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.
Last Date to Apply for Job: 12/16/2019
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.