Principal Scientist/Group Leader, Microbiology Strategy and Testing

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

As a Principal Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality. You will be recognized as a technical expert and a significant scientific contributor. With your deep knowledge of the discipline, you will regularly contribute at the therapeutic area level and can represent the department on multidisciplinary teams.

The qualified candidate will join the Analytical R&D Microbiology Strategy and Testing (MST) organization to enable development of biological therapeutics in St. Louis/Chesterfield, MO. The Group Leader is accountable for overseeing the day-to-day laboratory and Environmental Monitoring schedule and operations in St. Louis/Chesterfield (which may include support for Drug Substance manufacturing and Cell Banking). The Group Leader will manage the MST team in St. Louis/Chesterfield and report to the Senior Director of MST, to ensure that daily microbiology deliverables are met to enable all Tox/FIH milestones that are related to microbiology testing in St. Louis/Chesterfield.

How You Will Achieve It

The qualified candidate will manage 5-8 direct reports and d evelop team members by actively coaching, and providing development and learning opportunities.

The qualified colleague is responsible for utilizing established microbiological methodologies to support GMP in-process, release, and stability testing of clinical supplies. Ensures test turn-around, data review, and microbiological investigations meet all metrics. Performs bioburden, sterility, and endotoxin testing, as well as microbial identifications. Performs water sampling, environmental monitoring, and (viable/non-viable), gas testing, and supports aseptic media fills.

Reviews GMP data utilizing LIMS and eLN. Issues deviations, laboratory investigations, and corrective actions. Authors SOPs, test methods, and method qualification protocols/reports. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. Collaborates with the S enior Director on coordinating the weekly/daily schedules and coordinates resources within team and between other departments to meet production and development objectives. Ensures the microbiology laboratory stays in compliance and is audit ready by performing self-inspection readiness activities and participates in regulatory audits and walk-throughs.

Qualifications

MINIMUM:

• A degree in microbiology, molecular biology, biochemistry, or related field
  
• BS and 12 years of experience
  
• MS and 9 years of experience
  
• PhD and 4 years of experience
  

DESIRED:

• Prior laboratory supervisor experience
  
• Subject Matter expert of microbiological methods and Environmental Monitoring in accordance to cGMP and regulatory guidelines
  
• GMP audit experience with regulatory bodies
  
• Experience with laboratory data systems such as Laboratory Information Management Systems (LIMS)
  

PHYSICAL/MENTAL REQUIREMENTS

• Position requires occasional light lifting and periods of standing, sitting or walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Some occasional travel to other Pfizer sites or industry conferences is possible.

Other Job Details

• Last Date to Apply for Job: April 14, 2021
• Eligible for Employee Referral Bonus: Yes

#LI-PFE

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