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GTx Drug Product Lead

Pfizer


Location:
Sanford, NC
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

**ROLE SUMMARY**



Initially this position will be a project role performing Quality Assurance activities associated with the verification and compliance activities in support of Facility Verification and cGMP readiness for the new Gene Therapy Facility, Sanford, NC.



Key responsibilities will be Quality Assurance approver on Verification documentation and ensuring the facility is cGMP ready; SOP's (compliance with PQS's), raw material qualification, training etc. Working with the other Quality Team members on all operational readiness activities to ensure the Facility is GMP ready.







Once the Facility has been handed over to the site the role will transition to a Quality Operations role.



Quality oversight will encompass Drug substance manufacture, Drug Product manufacture and final label and release activities. The primary focus of the role will be implementing and maintaining Drug Product visual inspection, packaging/labeling and release procedures for the facility.







Key responsibilities are performing Quality Assurance activities as Quality final authorization/approval/release of cGXP documentation/equipment/processes, carry out investigations and final disposition of labelled Drug Product.



Plans and executes complex projects; suggests improvements and conducts continuous improvement activities; and provides guidance/coaching to less experienced colleagues.







**ROLE RESPONSIBILITIES**



Project Phase - Quality Assurance activities as per the Project Verification Plan.



Compliance activities to support the Facility is cGMP readiness - SOP's, training, raw material qualification etc.







Operations Phase - Quality Assurance Activities associated with ensuring the Facility is cGMP ready and operational e.g. SOP's, Batch Documentation, training, engineering runs, process simulation studies and other activities as required.







Providing Quality Review/Oversight of cGXP documentation related to the operation of a Gene Therapy manufacturing facility/laboratory to ensure compliance with global regulatory agencies and Pfizer quality standards.







Responsible for final authorization/approval/release of documentation/equipment/processes.



Responsible for Final Disposition of labelled Drug product







Organizes and provides written and/or oral presentations of work with minimal input.







Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility/laboratory. Plans and leads highly complex projects to ensure their timely completion.







Interfaces with other parts of the organization such as Global Compliance Division, Global Quality Operations groups, Regulatory Affairs, and Pfizer Research and development groups.







Responsible for knowing, understanding and acting in accordance with cGXPs, Pfizer's values and our OWNIT culture.







**QUALIFICATIONS**



8 -10 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field



5 -7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field



0 -1 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph. D in Science/related field



Required Quality experience/skills:







+ Drug Product batch release







Quality experience/skills:







+ Understanding of cell based manufacturing/research







Understanding of QTS, SAP, LIMS







**PHYSICAL/MENTAL REQUIREMENTS**



Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time. Require working in an office setting where sitting and computer usage would be the norm.







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



Limited travel for the position; no more than 15% traveling.



It will be necessary to work in areas that require aseptic gowning.







**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.







+ **Last Date to Apply for Job: 10 November, 2017**



+ **This job is (Pfizer) (Exempt) (US/PR) Grade: 010**







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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