BQ Senior Scientist

Employer
Pfizer
Location
Rocky Mount, North Carolina, United States
Posted
Nov 20, 2020
Ref
4791112
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

The Senior Scientist will work within the Biological Quality (BQ) Quality Control department. The BQ Quality Control department is responsible for ensuring that quality control procedures adequately evaluate Pfizer's products.

Under supervision, the Senior Scientist will function as the BQ Technical Lead for site projects, as directed by the BQ Principal Scientist. As the technical lead, the Senior Scientist will determine if current and/or proposed methods and techniques result in meeting reliability standards or require modification. The individual will also devise and implement testing plans, test methods, and equipment to assure reliability of product in conjunction with product design and specifications. The Senior Scientist will provide audit support during regulatory and customer audits.

The Senior Scientist will evaluate procedures and processes for gaps or ineffectiveness and recommend and/or perform corrective actions. In addition, the senior scientist conducts/supports investigations and corrections including remediation, test method validation/transfer/verification, risk assessments and evaluation of environmental and microbiological finished product data and manages the associated change controls.

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

The individual is required to have experience in Environmental Monitoring (EM) and/or Microbiological Finished Product Testing and a thorough working knowledge of the appropriate regulations. The individual will be expected to gain knowledge of the site's Laboratory Information Management Systems (LIMS) and the site's manufacturing facilities to assess for aseptic compliance.

ROLE RESPONSIBILITIES
  • Design and execute test method validation and verification protocols. Prepare technical reports based upon test 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 BQ Technical Lead for site compliance projects
  • Assess product/material compatibility for microbiological, bioanalytical, and/or analytical test method design and routine microbiological monitoring
  • Perform Quality Risk Assessments in support of drug product manufacturing and laboratory operations
  • Function as a Responsible Person for site change controls
  • Create Environmental Monitoring (EM) and Quality Control sampling and test plans


BASIC QUALIFICATIONS

Education

B.S. Degree in Biological Science related field with 6-8 years' experience with increasing roles and responsibilities.

Experience

Test method development and validation of various bioassay and microbiological test attributes

Environmental Monitoring (EM) or Microbiological and bioanalytical pharma quality control or research and development testing.

Creation of technical reports

Conduct or provide SME support of laboratory investigations

PREFERRED QUALIFICATIONS

Education

B.S. Degree in Biological Science related field 8-10 years' experience with increasing roles and responsibilities.

M.S. Degree in Microbiology or Biological Science related field with 3-4 years' experience.

Additional Experience

Assessment of drug substance, drug product, and raw material for microbiological compliance

Quality Control Test Plans

Cleanroom Design and Facility Qualification

Aseptic Process Simulations

Microbial Hold Time Studies

Cleaning Validation Studies

Sterilization/Depyrogenation Equipment Studies

Microbial characterization

Microbial excursion investigations

Regulatory and Customer Audits

Assessment of drug substance, drug product, and raw material for microbiological compliance

Quality Control Test Plans

Cleanroom Design and Facility Qualification

Aseptic Process Simulations

Microbial Hold Time Studies

Cleaning Validation Studies

Sterilization/Depyrogenation Equipment Studies

Microbial characterization

Microbial excursion investigations

Regulatory and Customer Audits

Microbial Retention Studies

Container Closure Studies

PHYSICAL/MENTAL REQUIREMENTS

Physical Requirements

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

Mental Requirements

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 Job Details:

Last Date to Apply for Job: December 2, 2020

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