Bioanalytical Testing Lab- Microbiologist

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jun 11, 2022
Ref
4857009
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to bioanalytical testing will help Pfizer provide safe drugs to patients.

Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.

As a Scientist, your deep knowledge in the discipline, will make you an active team member who influences at the project team level. You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

It is your knowledge and skills that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Contribute to achievement of goals at the work group/ project team level as a full team participant.

  • Perform tasks associated with maintaining {Current} Good Manufacturing Practices {part of GxP} for compliant Quality Control laboratories.

  • Represent Quality Control Bioanalytical testing labs in cross functional and site product meetings.

  • Interact with other team members within the Microbiology Department and with team members from other departments, primarily within the Quality and Drug Product organizations.

  • Interface with many levels of the organization including Laboratory Technicians, Staff Microbiologists, Production Operators, Quality and Operations Management, and internal/external Regulatory Auditors.

  • Collate, Interpret, and present data to make recommendations and reach decisions based on data and management input.

  • Apply existing techniques and procedures to implementation of modifications for improved efficiency, or devise and develop new microbiological techniques and procedures and participate in issue resolution.

  • Train junior colleagues, help develop training plans and oversee training activities for groups with unit training coordinator.

  • Provide subject matter expertise for standard operating procedures and quality standards content, as well as providing gap analysis to ensure that the program is compliant with all regulatory requirements and update as needed.

  • Support change controls, investigations and other technical documents.

  • Participate in regulatory filing writing in sections related to analytical method and stability testing.

  • Conduct and review non-conformance investigations related to testing of materials in lab.

Qualifications

Must-Have
  • Bachelor's Degree in the Biological Sciences and 5+ years' of relevant experience

  • Experience using laboratory information management systems and quality tracking systems

  • Expertise with development, optimization, and validation of ELISA, Gel electrophoresis, blood and cell-based assays, and various protein/nucleic acid binding assays.

  • Demonstrated independent accomplishment of complex bioanalytical method development and validation.

  • Ability to recognize atypical data, inform supervision of relevant problems, and implement solutions.

  • Ability to receive feedback and takes accountability for actions and personal development.

  • Excellent effective written and verbal communication and interpersonal skills.

  • Basic computer skills, such as data entry, with a high level of attention to detail, are also required.

Nice-to-Have
  • Master's degree in Biological Sciences and 4+ years of relevant experience

  • Experience with flow cytometer, capillary gel electrophoresis, and coagulation assays highly desirable.

  • Experience with GMP.

  • Experience with IMEX

  • Experience leading continuous improvement projects

  • Experience defending laboratory practices in regulatory audit.

  • Experience using Lean, Six Sigma,and other continuous improvement methodologies for process improvement is highly desirable.


PHYSICAL/MENTAL REQUIREMENTS

Job duties may involve sitting for extended periods while working at computer terminal.

Job will involve extended periods of working at a lab bench or in a biosafety hood.

Must have good analytical skills and ability to interpret chromatograms, electropherograms, and spectrophotometer output.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Job may require working off shift at times, and/or some travel.

  • ​Work Location Assignment:On Premise

Other Job Details:

  • Last Date to Apply for Job: June 24, 2022

  • Eligible for Relocation Package

  • Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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