1+ months

Associate Scientist, BioProcess Engineer

Pfizer
Andover, MA 01810
**ROLE SUMMARY**

The clinical manufacturing Associate Scientist, Process Engineer/Scientist is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

At Pfizer, we innovate every day to make the world a healthier place. It was the vision of 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 Process Engineer / Scientist functions as part of a multi-disciplinary team responsible for delivery of cGMP phase I/II clinical drug substance supporting the Pfizer Biotherapeutics R&D portfolio. The initial focus is on the start-up and readiness of a new purification suite, including, but not limited to, support of facility/equipment commissioning and qualification, creation of all associated cGMP procedures, design and procurement of processing aids and equipment, and training of operations colleagues.



Post-suite start-up, the successful candidate will support and execute cGMP downstream purification / formulation processes. Support functions will include owning and leading deviation and investigations, CAPA implementation and resolution, 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**



+ Support, mentorship, and training of operations colleagues

+ Execute and troubleshoot all unit operations associated with microbial processing including upstream / fermentation and purification / separation processes in a cGMP environment. Includes support and troubleshooting of CIP and changeover operations.

+ Lead tech transfer activities for new products, product changeover, and host cell 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

+ Lead/support implementation of new technologies and equipment

+ Lead/support investigations and audits as needed



**BASIC QUALIFICATIONS**



+ BS/BA in Biotechnology, Microbiology, Biology, Cell Biology, Chemical Engineering, Biochemistry or equivalent

+ 0-2 years of experience in a laboratory or manufacturing environment



**PREFERRED QUALIFICATIONS**



+ Delta V expertise

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

+ In depth knowledge of harvest, chromatography, aseptic processing, and filtration processes

+ Operational experience with operation of Fixed (AKTA Process) and single use systems (Millipore POD)

+ Experience with Production Control Systems and data historian systems (i.e. DeltaV, PI, mind2, canary), ERP Systems (i.e. Axis360 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 operate, train, and lead a diverse team

+ Excellent oral and written communication skills

+ Ability to thrive under minimal direct supervision



**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.



**Other Job Details:**



+ Eligible for Employee Referral Bonus: yes



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

Posted: 2019-08-23 Expires: 2019-11-09

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Associate Scientist, BioProcess Engineer

Pfizer
Andover, MA 01810

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