Pfizer External Supply Tech Transfer Leader in Lake Forest H3, Illinois
Provides technical leadership and is a primary point of contact for CMOs (Contract Manufacturing Organizations) for Pfizer Essential Health (PEH) PharmSci products. The role is involved in the collaborative development of products for PEH and works directly to provide guidance for CMO groups that are supporting PEH PharmSci products. Focused on global product development through commercial launch.
This individual must be able to work in a collaborative environment and must be able to effectively communicate to both internal and external customers. To be successful, the position must interface effectively with analytical, formulation, microbiology, regulatory, operations, quality and other departments, serving as the group's authority to senior leaders in these areas. The role oversees and manages the tech transfer and scale-up of sterile injectable (includes solutions, lyophilized products, suspensions and emulsions) and ophthalmic pharmaceutical dosage forms (includes solutions, suspensions) and must have a fundamental understanding of cGMP, sterile operations, etc.
The individual will be expected to provide detailed technical, process understanding and expertise in support of complex technical investigations, process troubleshooting, technical transfer, scale up, as well as engineering and exhibit batch manufacturing. The individual will be instrumental in facilitating project and technical ownership to PGS (Pfizer Global Supply) prior to PV (Process Validation)/commercial batch manufacturing.
The individual should be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc) and will provide the support working with the contract manufacturing organization for coordinating manufacturing activities and troubleshoot complex or unusual problems arising from components, process, equipment and system failures. The individual should have experience in the area of overall sterile process execution in support of cGMP clinical, engineering, ANDA, PV and /or commercial batch manufacturing.
The individual will be expected to leverage collaboration across multiple groups and competing priorities and should have extensive understanding and experience dealing with large technical group of engineers, scientist and technicians in large multi-product contract manufacturing facilities. The role serves as the operations point of contact for technology transfer and manufacturing and should be knowledgeable of the documentation necessary for tech transfer of new products, including tech transfer plans and risk assessments.
The individual must have a working knowledge of cGMP compliance expectations and 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., and will advise management of non-conformance issues and opportunities for continuous improvement.
This position works in a team environment with internal development scientists and Contract Manufacturing Organizations to execute processing and operational activities in support of manufacturing of sterile injectable and ophthalmic pharmaceutical dosage forms. The role will work to further foster the relationship with CMOs. Requires detailed knowledge of technology transfer and scale up. Must be capable of assessing challenges and able to provide technical support to resolve the technical issues during the manufacturing. Able to trouble shoot/recommend the solutions to resolve the technical issues with manufacturing equipment. Able to handle multiple projects simultaneously at different CMOs. Able to travel globally, up to 30 % to CMOs for technical meetings, technology transfer, demonstration / engineering / exhibit batches. Author, review, and/or approve site technology documents such as tech transfer plans, risk assessments, validation protocols, reports, batch records, sampling protocols, CAPAs, change controls, procedures, policy and instructions, etc. Responsible for working with R & D group in optimizing process parameters (with commercial processes in mind) within the design space to evaluate/implement opportunities for process improvements. Collaborate with R & D colleagues for required process development and analytical support needed to address process issues and solutions. Participate as needed in reviewing/authoring relevant regulatory and/or technical documents in support of implemented technologies or changes in the manufacturing process and evaluate the impact on the quality of the product Requires understanding of scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on sterile injectable pharmaceutical dosage forms. Participate in cross-functional teams in the evaluation and implementation of novel manufacturing technology and processes in commercial processes that increase process robustness and promote a culture of innovation and continuous improvement.
- B.S. and minimum of 15 years of drug development/tech transfer/manufacturing experience or M.S. or Ph.D. and minimum of 8 years of drug development/tech transfer/manufacturing experience. Preferred education background in Pharmaceutics, Engineering or similar discipline, however, extensive experience with tech transfer processes may be substituted for education.
Working knowledge of project management concepts and tools
Significant experience in process development and scale-up
Significant experience with tech transfer of drug products in or out of manufacturing sites
Self-driven and self-motivated
Track record of responsibility for multiple development projects
May need to enter and participate actively in manufacturing areas to support tech transfer, scale up, or various aspects of the drug development process.
Travel (domestic and abroad) up to 30% and should be available for meetings to accommodate various time zones of CMO partners.
EEO & Employment Eligibility
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Hospira Grade 18
Last day to apply for job: 9-14-17
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