14 days old

Scientist, Clinical Manufacturing

Pfizer
Chapel Hill, NC 27514
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**ROLE SUMMARY**

At Pfizer, we innovate every day to make the world a healthier place. It was the vision of Charles Pfizer at the very beginning and it holds true today in everything we do. From scientific discovery to breakthrough products to our essential partnerships around the world, we're committed to quality healthcare for everyone. Because every individual matters. Our medicines and vaccines save or improve countless lives and our consumer products empower people to take care of themselves. Pfizer Corporate Responsibility believes that all individuals, everywhere, deserve access to quality healthcare and the opportunity to lead healthy lives.



The Scientist (process engineer) functions as part of a multi-disciplinary team responsible for delivery of cGMP phase I/II clinical gene therapy drug substance and drug product supporting the Pfizer Biotherapeutics R&D portfolio. The successful candidate will support and execute cGMP gene therapy bioprocess unit operations with a particular emphasis on downstream purification / separation processes. Support functions may include owning and leading deviation and investigations, CAPA implementation, operational and continuous improvement projects.



Diversity, equality and inclusion are an integral component of Pfizer's mission to build a vibrant culture. We maintain the highest standards of ethics and compliance in all of our business practices.



**ROLE RESPONSIBILITIES**



+ Execute and troubleshoot all unit operations associated with gene therapy processing including upstream / fermentation and purification / separation processes in a cGMP environment..

+ Lead tech transfer activities for new products and product changeover for operations team

+ Authorship of and execution against SOP's for downstream unit operations

+ Lead/support the creation of manufacturing batch records and other cGMP documentation

+ Data analysis and communication/collaboration with tech transfer team, development labs and quality

+ Training of operations colleagues

+ Lead/support implementation of new technologies and equipment

+ Lead/support investigations and audits as needed



**BASIC QUALIFICATIONS**



+ Bachelor's Degree with 3-6 years of experience or Master's Degree with in 2-4 years of experience in a laboratory or manufacturing environment with degree in Biotechnology, Microbiology, Cell Biology, Chemical Engineering or Biochemistry.

+ Experience in a GMP environment with increasing responsibility is required.

+ Proven ability to troubleshoot complex processing issues and ability to make decisions with minimal guidance required.



**PREFERRED QUALIFICATIONS**



+ Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting

+ Knowledge of harvest, chromatography and filtration processes

+ Experience with operation of flexible and single use systems

+ Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)

+ Ability to execute against SOP's and document entries in a compliant manner

+ Demonstrated capability to work as a team member in a matrix manufacturing team

+ Excellent oral and written communication skills

+ Ability to work under minimal supervision



**Other Job Details:**



+ Eligible for Employee Referral Bonus: Yes

+ \#LI-PFE



**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.



**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.



Research and Development
Posted: 2020-03-16 Expires: 2020-04-16

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Scientist, Clinical Manufacturing

Pfizer
Chapel Hill, NC 27514

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