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Technical Transfer Leader, Pharmaceutical Science (Manager)

Pfizer


Location:
Mcpherson, KS
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1618814
Pfizer
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Job Details

Job Title Technical Transfer Leader, Pharmaceutical Science (Manager)

JobID 1618814

Location: Mcpherson, KS

Description The Tech Transfer Leader at McPherson, KS Pfizer site is accountable for the successful execution of technology transfers of all new PEH R&D products (Generics and Biosimilars) from R&D to the manufacturing facility. The Technical Transfer Leader is the liaison between the Core Team and manufacturing facility to ensure successful introduction of new products following the established business plan. They are responsible for presenting issues and updates to the appropriate leadership for resolution as well as for highlighting status updates to global R&D partners and plant management. They are the single point of accountability (SPA) for the project they are leading. This is an individual contributor role but the colleague will influence cross functional teams on a daily basis.



+ Facilitate/lead/coordinate site focused core team activities in support of technology transfer (document review and approval; knowledge transfer; process and assay transfer) to ensure that all relevant information, processes/methods, and materials are successfully communicated and utilized during manufacturing in accordance with agreed upon timeline.

+ Track team activities and timelines to ensure that the deliverables within the project plan are met and are on-time.

+ Coordinate all communications (main 'point of contact') pertaining to tech transfer to and from collaborative partners.

+ Track and ensure completion of critical documentation for the Tech Transfer process (e.g., Tech Transfer Plan, Process Description, Drug Substance and Drug Product Monographs, Batch Records, Risk Assessments, Change Requests).

+ Generate and/or review documentation supporting technology transfer (e.g., checklists, protocols and reports, risk assessments, tech transfer plans/reports, as appropriate).

+ Prepare, distribute & present project status reports to project team members and management.

+ Manage and set priorities for specific projects/programs.

+ Contribute to regulatory filings, as required, including authoring CTD sections and peer review of submissions.



**QUALIFICATIONS**



+ B.S. and 15 years, Ph.D. + 5 years, or M.S. + 10 years of relevant pharmaceutical development experience (process/manufacturing/project management).

+ Detail and planning oriented

+ Able to work autonomously on routine tasks

+ Good oral and written communication skills



**PHYSICAL/MENTAL REQUIREMENTS**

Working environment involves normal office environment. Occasionally, laboratory and manufacturing working environment where procedures, PPE (personal protective equipment) or protective apparel/devices may be needed to address noise, dust, fumes, safety hazards, etc. May need to enter and participate actively in manufacturing areas to support tech transfer, scale up, or various aspects of the drug development process which would involve long periods of standing.



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

Colleague will work standard 1st shift work schedule, however, additional hours outside of this (including weekends) are required frequently to support conference calls with international groups and oversight of engineering and exhibit batches. Some travel will be required, albeit limited to 1-2 times per year.



**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



**OTHER INFORMATION**



+ Eligible for a relocation package

+ Eligible for employee referral bonus

+ Hospira grade 18

+ Last day to apply: November 26, 2017



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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