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External Supply Tech Transfer Leader


Lake Forest H3, IL
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Job Details

Job Title External Supply Tech Transfer Leader

JobID 1606871

Location: Lake Forest H3, IL

Description 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.

Experience expected:

+ 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**

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.

Hospira Grade 18

Last day to apply for job: 9-14-17

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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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