Principal Scientist

Role Summary

Manufacturing Sciences and Technology (MSAT) at Pfizer is looking for a highly motivated, versatile candidate to join our multidisciplinary team of scientists and engineers in Andover, MA as a Principal Scientist, MSAT Downstream. The group supports Pfizer's portfolio of late stage development and commercial biopharmaceuticals and vaccines, and is responsible for process troubleshooting, process improvements and second generation process development. We are looking for someone who is eager to contribute independent thinking and technical leadership. The ideal candidate should have a solid understanding and experience with all downstream/purification operations for bioprocess macro-molecules such as antibodies, cytokines and large polysaccharides. The candidate must be able to lead the design, execution and interpretation of complex studies requiring highly organized data collection and management.

As the team supports multiple manufacturing teams in complex troubleshooting activities, it is expected that the candidate be a proficient user of problem-solving and risk analysis tools, and have a strong understanding of regulatory environment impacted by change or deviations. It is highly desirable that the candidate is a routine practitioner of the Lean/Six Sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.

Basic Qualifications

• PhD with 8+ years, MS with 10+ years, or BS with 12 + years of experience in scientific / technical roles within the biotech industry supporting the development and commercialization of therapeutic recombinant proteins or vaccines, experience in biosimilar development highly desirable
• Previous experience in designing and executing components of major experimental programs for biologics drug substance production in the laboratory or pilot-plant setting.
• Proficient user of problem-solving, risk analysis and statistical tools
• Highly proficient in common purification tools with considerable experience in associated transfer and scale up
• Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry. Direct experience interacting with the regulatory authorities either through meetings at the agencies, through regulatory filings reviews, through production site-inspections or other similar circumstances.

Preferred Qualifications

• Will have graduated over time to oversight of the execution of similar experimental programs by groups under his/her direct supervision.
• Practitioner of the six sigma and Continuous Improvement suite of tools including DMAIC, VSM, SIPOC, Visual Management, 5S etc.
• Experienced in use of Design of Experiment (DoE) methodology and associated software (JMP, MiniTab) and other statistical tools
  

Physical/Mental Requirements

Will require significant data analysis, authoring and reviewing complex technical and regulatory documents and likely some review and/or authoring of batch records and SOPs for use in a cGMP environment.

Non-standard Work Schedule, Travel Or Environment Requirements

• May require some out of hours working to support laboratory work or participation in teleconferences with other global sites.
• Some travel may be required, but is not expected to be a standard aspect of role (

OTHER INFORMATION

• Last Date to Apply for Job: 5/14/21
• Eligible for employee referral bonus

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

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