Manager, Microbiology Method Development

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

The Manager, Microbiology/Chemistry Method Development will work within the Quality Control Laboratory department. The Quality Control Laboratory is responsible for ensuring that quality control procedures adequately evaluate Pfizer’s products.

The Manager, Microbiology/Chemistry Method Development will function as the QC Technical Lead in the area of Microbiology or Chemistry for site projects. As the technical lead, the Manager, Microbiology/Chemistry Method Development will determine if current and/or proposed methods and techniques result in meeting reliability standards or require modification. The Manager, Microbiology/Chemistry Method Development will also devise and implement test plans, test methods, and equipment protocols to assure reliability of product in conjunction with product design and specifications.  The Manager, Microbiology/Chemistry Method Development will provide audit support during regulatory and customer audits.

The Manager, Microbiology/Chemistry Method Development will evaluate procedures and processes for gaps or ineffectiveness and recommend and/or perform corrective actions. In addition, the Manager, Microbiology/Chemistry Method Development conducts and/or supports investigations and corrections including remediation, test method validation/transfer/verification, risk assessments and evaluation of microbiological or chemical product data.

The Manager, Microbiology/Chemistry Method Development will be expected to develop collaborative relationships with the staff in each of the Business Units and the appropriate Quality representatives to facilitate continuous improvement of the applicable areas.  The Manager, Microbiology/Chemistry Method Development will consult with laboratory management to establish practices and procedures that comply with regulatory agencies.

The Manager, Microbiology/Chemistry Method Development is required to have experience in microbiological (i.e. Sterility, BET, Bioburden, Sub-visible Particulate, Microbial Identification, and Assay) or chemical testing and a thorough working knowledge of the appropriate regulations.  The individual will be expected to gain knowledge of the site’s manufacturing operations to assess for microbiological or chemical compliance.

How You Will Achieve It

• Manage team of scientists, including goal setting and metrics.

• Draft, review and approve scientific protocols and reports, and method validation assessments.

• Design and execute test method validation and verification protocols. Prepare technical reports based upon executed protocols and biological quality concepts.

• Provide Subject Matter Expert (SME) support for site investigations and design test experiments in support of laboratory investigations.

• Function as the QC Micro or Chemistry Technical Lead ensuring biological or chemical method compliance for site projects and audits.

• Assess product/material compatibility for microbiological, bioanalytical, and/or analytical test method design and routine microbiological or chemical monitoring

• Maintain Compendia updates for USP/EP/JP/BP and other compendia as required

Qualifications

Must-Have

• PhD Degree, in Biological Sciences or Chemistry related field preferred, with 0+ years’ experience with increasing roles and responsibilities.

• OR MS Degree, in a Biological Sciences or Chemistry related field preferred, with 3+ years’ experience with increasing roles and responsibilities.

• OR BA/BS Degree, in a Biological Sciences or Chemistry related field preferred, with 5+ years’ experience with increasing roles and responsibilities.

• OR AA/AS Degree, in Biological Sciences or Chemistry related field preferred, with 8+ years’ experience with increasing roles and responsibilities.

• OR Applicant must have a High School Diploma (or Equivalent) and 10+ years of experience in Biological Sciences or Chemistry related field with increasing roles and responsibilities.

• Quality control experience in sterile drug product Pharmaceuticals, Biotech, Research & Development and/or other highly regulated laboratory. 

• Test method development and validation of various bioassay and microbiological or chemical test attributes

• Must be viewed by peers, supervisors and managers as having strong technical and leadership skills.

• Demonstrate strong research skills

• Must be able to communicate / explain analytical concepts to regulators, project team members, customers, etc.,

• Demonstrate strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.

• Demonstrated ability to investigate and identify causes of suspect laboratory results.

• Strong knowledge of analytical and/or microbiological method design.

• Strong technical writing skills and use of Excel.

Nice-to-Have

• Prior leadership experience as a group lead, supervisor and/or manager.

• General knowledge of product formulation, including sterilization processes for microbiologist, and the impact to analytical method design .

• Prior experience in Regulatory and Customer Audits

Physical / Mental Requirements

• Standing while working within a Biological Safety Cabinet and/or Laminar Flow or Chemical Fume Hood for extended periods of time.

• Identify and solve moderate to complex problems and provide relevant, effective solutions

• Ability to perform moderate to complex mathematical calculations

• Ability to perform Moderate to complex data analysis

• Moderate to advanced computer skills

Non-Standard Work Schedule, Travel, or Environment Requirements

• Overtime and weekend work are required as needed.  Occasional travel may be required.
   

Other Information

• Relocation support available

• Work Location Assignment: On Premise

Last date to apply: 2/3/2023

Relocation assistance may be available based on business needs and/or eligibility.

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