Senior Associate Scientist, ARD Microbiology

4 days left

Employer
Pfizer
Location
Saint Louis County, Missouri, US
Salary
Competitive
Posted
Apr 28, 2021
Closes
May 11, 2021
Ref
2139777525
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
ROLE SUMMARY
The qualified candidate will join the Analytical R&D Microbiology organization to enable development of biological therapeutics in St. Louis, MO. The candidate will perform Environmental Monitoring (EM) of Cell Banking, and Drug Substance facilitates, as well as for water, clean steam, and compressed gasses. The qualified candidate will also be responsible for applying GMP microbiological methods (bioburden, LAL, PCR, etc.) in the assessment of product quality.
ROLE RESPONSIBILITIES
This is a laboratory-based role, with approximately 80% of time supporting routine GMP testing and environmental monitoring, utilizing established microbiological methodologies to support GMP in-process, and release testing of clinical supplies.
The individual will be proficient in aseptic lab technique and facility gowning for EM, bioburden and LAL testing, microbial identifications, PCR assays, preparation of stock cultures, and media release testing. This role will require the qualified individual to stay updated with current microbiological regulations, trends, and technical aspects in the industry. In addition, the qualified colleague may be responsible for sample management activities, including tracking and shipping of samples and managing sample receipt and transfers in electronic notebook systems.
The colleague must work within corporate guidelines and must appropriately record, archive and report all data as this is a cGMP compliant laboratory. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team. The candidate must thrive in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask and effective interpersonal, influencing skills and communication skills are required.
BASIC QUALIFICATIONS
- Master's degree with 2+ years of experience in a GMP biotechnology microbiology laboratory, or Bachelor's degree with 4+ years of experience in a GMP biotechnology microbiology laboratory.
- Proficient in aseptic lab technique and facility gowning for environmental monitoring.
- Prior experience with EM sampling including air, surface, water, steam, and compressed gasses.
- Prior experience with compendial microbiological methods (LAL/endotoxin, Bioburden) in support of GMP manufacturing.
- Experience with laboratory data systems such as Laboratory Information Management Systems (LIMS) and eLN.
- Excellent GMP documentation skills and ability to follow established procedures under minimal supervision.
- Must appropriately record, archive and report all data.
- Must be able to self-manage and meet strict timelines, while working in a team-based environment.
PREFERRED QUALIFICATIONS
- Direct experience with audits and working with FDA or other regulatory authorities helpful.
- Experience with PCR testing for microbial ID, mycoplasma, and MMV.
- Knowledge of drug development process for progression of biological candidates.
- Degree specifically in microbiology, bacteriology, or virology
PHYSICAL/MENTAL REQUIREMENTS
- Position requires occasional light lifting and periods of standing, sitting or walking.
- Ability to gown for aseptic facility.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Very occasional travel.
Other Job Details:
- Last Date to Apply for Job: May 7, 2021
- Eligible for Employee Referral Bonus
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.
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