Principal Scientist- Downstream Process Development
Pfizer Inc.
Andover, MA
Job posting number: #7151261 (Ref:pf-4885923)
Posted: May 31, 2023
Application Deadline: Open Until Filled
Job Description
Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
What You Will Achieve
Job purpose is to provide science and technology expertise and leadership in purification process development technologies and all associated aspects of downstream process development technologies used in support of the development, characterization and commercial manufacturing support of: recombinant proteins, RNA vaccines, conjugated polysaccharide vaccines, monoclonal antibodies including bispecific, enzymes, and localization programs, budget and continuous improvement.
How You Will Achieve It
MSAT point of contact with external stakeholders for recombinant proteins, RNA vaccines, conjugated polysaccharide vaccines, monoclonal antibodies.
Key liaison between MSAT, R&D, manufacturing operations team and site technical services team at Tier Meetings for all day-to-day operational support.
Lead technical sub teams and be the MSAT point of contact on network technical teams for recombinant proteins, mRNA vaccines, conjugated polysaccharide vaccines, monoclonal antibodies.
MSAT point of contact for technical transfers on site for all drug substance process transfers within the remit of the process development teams at Pfizer.
Point of contact for external supply operations for the MSAT process development team for recombinant proteins, mRNA vaccines, conjugated polysaccharide vaccines, monoclonal antibodies, and localization programs.
Represent MSAT in cross-functional teams in support of commercial and late-stage development products.
Manage, mentor, and guide junior team members (Associate Scientist to Sr. Scientist).
Participation with the purification Sr. Manager and other senior members of the process development team in the long-term strategic planning of all downstream process development team activities.
Representation of the process development team in the chosen technical field at inter-company project meetings, project meetings with third party partners, regulatory and scientific industry meetings.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
Previous experience in designing and executing components of major experimental programs for biologics drug substance production in the laboratory or pilot-plant setting.
People Leadership experience is a must.
Demonstrated expertise in the application of NMR techniques for evaluating biological structures.
Sound understanding of statistical experimental design and analysis is a benefit.
Strong working knowledge of the drug development process for progression of a biological incumbent.
Organized, self-motivated, and capable of working independently with minimal supervision as well as in a collaborative environment of dedicated engineers and scientists.
Education and technical fields of experiences should include specific knowledge and practical experience in the majority of large molecule bioprocessing and separation sciences, analytical technologies, protein biochemistry, glyco-biology, protein structure and conformation, physical chemistry of molecular interactions at interfaces, mass transfer principles and drug stability studies.
Experience in all aspects of process development, process characterization, scale-up programs, and technology transfer for proteins, pDNA, mRNA and glyco-conjugate vaccines, monoclonal antibodies.
Proficient with the use of a variety of problem-solving, risk analysis and statistical tools.
Experienced in regulatory dossier compilation and developing CMC responses.
Working knowledge of the Quality/GMP/ICH/compliance systems of the biopharmaceutical industry.
Nice-to-Have
Experience in supporting scale-up and technology transfer to pilot or commercial scale facilities.
Extensive experience with protein and carbohydrate chemistry in general and bioconjugation chemistry specifically is strongly desired.
Proficient in benchtop bioreactor or chromatography operations.
Other Job Details:
Last Date to Apply for Job: June 13th, 2023
Work Location Assignment: On Premise
Relocation Support Available
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.
