St Louis, MO
Job posting number: #7115797 (Ref:4870682)
Posted: November 10, 2022
Application Deadline: Open Until Filled
Job DescriptionWhy 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
As a Stability Strategist/Principal Scientist, you will be at the center of our Analytical R&D QCSV Stability operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality and compliance. With your deep knowledge in the discipline, you will be an active team member who influences across a matrixed organization and at the project team level to enable the development of biological and vaccine drug candidates. You will be using your skill sets to implement stability strategies, design and/or implement new stability tools in support of drug candidates throughout clinical development to registration. Your ability to plan will help in preparing short and long-term work activities on projects. You will undertake mentoring activities to guide your team members about the implementation of a variety of stability strategies and tools. It is your hard work, dedication, and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Executes stability strategies for biotherapeutic products in support of clinical and commercial products
Critically assesses and summarizes analytical results including but not limited to Compendial test methods, HPLC, electrophoresis, PCR, and various bioassays in order to support product stability
Leads the implementation and oversight of project stability programs for multiple large molecule biotherapeutics in order to enable clinical studies in a GMP environment.
Authors stability filings and submissions, HA queries, and other key regulatory documents.
Manages data and data verifications in electronic laboratory information management system (LIMS) and/or global document management systems (GDMS)
Communicates project plans, stability strategies, stability mitigation plans and project risks to management and key stakeholders.
Actively participates and reports progress into matrixed project teams to meet customer expectations and project milestones.
Contributes to the achievement of goals and influences at the work group/project team/cross-line level.
Complies with cGMP requirements, regulatory guidelines, and corporate policies.
Bachelor's Degree with 6+ years of experience OR masters Degree with 4+ years of experience
Experience with variety of large molecule and/or vaccine analytical techniques.
Experience with interdisciplinary drug development teams including experience developing analytical strategies in support of product and process development for biotherapeutics
Experience with the assessment of analytical data for underwriting the stability expiry and temperature excursion assessments for biological materials
Experience with statistics and statistics software to further critically assess stability data
Experience contributing to regulatory submissions including IND, BLA, and MAA and demonstrated leadership success in project progression is required.
This position requires highly motivated individuals with the ability to work closely with other members of the laboratory and the department in a matrix team environment.
Collaborative, team oriented leadership and management style essential. Demonstrated ability to drive for results and lead innovation and change.
Applicants should be bright, organized, self-motivated, and capable of working independently and in a collaborative environment.
Applicants should also have strong oral and written communication as well as analytical and computer proficiencies
Experience working with Quality Systems in a GMP environment
Knowledge of drug development process for progression of biological candidates through clinical trials to registration
Experience with laboratory data systems such as Empower and Laboratory Information Management Systems
Experience with audit preparations and regulatory inspections
Occasional light lifting, sitting, complex data systems and analysis
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional weekend work and possible travel to support projects
Work Location Assignment: On Premise, colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
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.