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Senior Principal Scientist, Process Development

Pfizer


Location:
Andover, MA
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.







The candidate for the Sr. Principal Scientist in Process Development will be required to lead the process development and manufacturing of all the polymer components for our ACCURINS nanoparticle platform. The position will direct engineers and scientists both within Pfizer and at CDMOs to lead the scale up, process understand, and initial manufacture of polymers to feed into pre-clinical and clinical materials for nanoparticle drug product. Additionally, the candidate will work closely with others in PharmSci to develop and optimize bioconjugations of novel ligands to these polymers and the surface of the nanoparticle. Finally, the candidate will help operate the pilot plant in support of nanoparticle scale up and development.







This person must have the personality and social skills to work within small teams and also the ability to navigate systems to accomplish tasks in a large company environment. This includes working closely with other departments and managing a functional group while representing PharmSci on numerous project teams. Strong communication skills are a must, as this person will disseminate information in many forums and also author and review excipient and drug product sections in the CMC sections of regulatory submissions. The candidate will also be needed to lead outsourcing of some development and clinical manufacturing. Experience with CRO or CMOs is required. Some travel will be required.







**MAIN RESPONSIBLITIES**







+ Effectively work with the wider Pharmaceutical R&D Group, Chemical Process Development Group, Analytical Development Group, and various Research Units to commercialize novel ideas relating to nanoparticle drug delivery.



+ Serve as the SME and point person for all things polymer-including materials, conjugations, and characterization.



+ Organize, evaluate, and present data in an effective and scientific manner.



+ Manage a lab and pilot plant for scale up work and process development.



+ Technology transfer of pre-clinical processes to manufacturing group.



+ Write and manage data acquisition and automation programs for manufacturing equipment skids.







**BASIC QUALIFICATIONS**







+ BS or advanced degree in biomedical, chemical, or process engineering with experience producing polymers, or an advanced degree in polymer chemistry with production-scale experience.



+ 9-13 years of experience in chemical process development or manufacturing.



+ Management experience with personnel, projects, and outsourcing.



+ Experience managing a team of scientist or engineers



+ Knowledge of cGMPs and sanitary process design and equipment



+ Knowledge of chemical/process engineering principles



+ Knowledge and experience with polymers, particularly polyesters and ideally PLGA-based systems



+ Experience in scaling up pharmaceutical processes



+ Mechanically inclined



+ Good communication skills, particularly written



+ Experience preparing batch records, lab reports, SOPs, and other cGMP documentation



+ Good organizational skills



+ Experience with outsourcing and/or contract manufacturing



+ Affable personality; ability to perform well under stress



+ Experience with data acquisition and PLC-based automation programs







**PREFERRED QUALIFICATIONS**







+ Experience with polymeric drug delivery forms and experience with nanotechnology



+ Knowledge of analytical instrumentation, particularly particle sizing and HPLC



+ Experience with chemotherapy drugs



+ Experience with lyophilization







**ADDITIONAL OFFER DETAILS**







+ **Last Date to Apply for Job: December 31, 2017**



+ **This job is Pfizer Exempt US Grade: 013** Additional Location Information: Andover, MA







**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.







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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