Pfizer Process Technology Manager in Sanford, North Carolina
Works as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support. Must have the cross-functional scientific ability/skills/knowledge to work in any of the clinical production areas including fermentation/recovery, purification, and conjugation chemistry. Quickly adapt to cross-functional training as needed to advance pipeline projects.
Works with minimal direct supervision and is responsible for leading and executing the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of manufacturing processes for clinical and launch campaigns of microbial and conjugate antigen programs. Maintain GMP documentation essential to documenting the manufacture of clinical grade materials. The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements.
Serves as the technical lead of technology transfer and process/equipment design projects, interfaces directly as the point-of-contact for technical issues with sending site customers and solicits feedback and technical insight from fellow group members.
Participate in clinical product tech transfer, production and capital projects in a technical leadership capacity. Perform technical transfer and process engineering activities with minimal supervision to implement processes in the manufacturing areas. This may include leading and/or 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.
As microbial and conjugate antigens progress through the research pipeline from Development through Phase III clinical production, the incumbent will work with internal and external development colleagues to map processes to the manufacturing facilities. This includes the following:
Provide lead process engineering knowledge and execution 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. Develop 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. Lead procurement of 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. Serves as the technical lead for technology transfer projects by serving as the point of contact with internal and external sending site customers. Ensures relevant technical information is relayed to group members and manufacturing colleagues, and solicits these personnel for feedback and improvement. Works with manufacturing to ensure readiness prior to the start of a production campaign. 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 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. 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 with area champion or supervisor input. 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 of equipment and process operations to ensure successful batch completion.
Coordinates the development and execution of studies to identify, resolve and/or correct manufacturing problems or process improvements, producing reports to substantiate findings, and establish validation acceptance criteria.
Participates in all internal and external audits related to validation activities.
Takes a leadership role in cross-functional teams to resolve problems to optimize output, minimize contamination, and minimize cost.
Provide effective leadership and direction to Technical Operations personnel; build and develop talent and work with the regional/global teams to ensure key talent is developed across locations/businesses
Support and enhance the technical capability of the manufacturing environment including process control and improvement. Implement process control and reporting tools to ensure process trends are reviewed in a timely manner
Interact with Manufacturing Operations, Engineering and Product Development groups to proactively assess people/facilities capabilities and capacity
Ensure consistency of application of validation concepts across the site and the network.
Accountable for ongoing compliance of all process and cleaning validation activities with cGMP requirements.
Provide day-to-day support for technical issues in Mfg
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical 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.
A minimum of a BS degree + 10 years of experience; MS + 7 years of experience; PhD + 4 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline
Other Job Details:
Last Date to Apply: April 22nd , 2021
Eligible for Employee Referral Bonus
Eligible for Relocation
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.
- Pfizer Jobs