Principal Scientist Downstream Process Development
Location
Andover, MA | United States
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 Master's degree with 9 years of experience; OR a Ph.D. with 4 years of experience.
- Must have 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 purification/downstream 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.
- Experience in supporting scale-up and technology transfer to pilot or commercial scale facilities.
- People Leadership experience is a must.
Nice-to-Have - Working knowledge of the Quality/GMP/ICH/compliance systems of the biopharmaceutical industry.
- HTS instrumentation for protein purification process development
PHYSICAL/MENTAL REQUIREMENTS Ability to communicate and work with cross functional teams.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Schedule is on 1st shift, standard Monday - Friday. Travel on need basis.
Work Location Assignment:On Premise
OTHER JOB DETAILS - Last Date to Apply for Job: February 12, 2024
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: YES
The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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. This position requires permanent work authorization in the United States.
Research and Development
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