Microbiologist I Quality Control Microbiology This position is located at the BioNTech Gaithersburg, Maryland, GMP manufacturing site. The Gaithersburg site includes functions supporting cell and gene therapy research, development, and GMP manufacturing operations. These collective functions result in a collaborative environment that is aligned from drug discovery to GMP release of drug product for our patients.
The QC Microbiologist I (as experience allows) is responsible for partnering with managers and subject matter experts in leading, supporting, and maintaining QC microbiological functions and contamination control for new and existing GMP manufacturing operations.
Primary responsibilities include: Support facility qualification operations for new GMP manufacturing areas, including Environmental Monitoring Performance Qualification (EMPQ) and GMP utilities qualification. Perform environmental monitoring (EM) of GMP classified cleanrooms. Perform sampling and testing of GMP utilities, including purified water and clean gases. Perform microbiological assays and operations such as Rapid Sterility, Rapid Endotoxin, Gram Stain, Microbial Identification, Growth Promotion, Bioburden, and plate reading. Review QC raw data, such as testing and logbooks. Support data management requirements for the team, including data entry and data verification, trending of data, and authoring of trend reports, utilizing Excel, LIMS, or other trending software. Perform routine maintenance of lab equipment and lab spaces. Conduct investigations for procedural deviations, out of specifications (OOS), and environmental monitoring / clean utility excursions. Determine and execute corrective and preventative actions (CAPA) as determined for investigations, excursions, and OOS. Support QC equipment qualification, including implementation of new rapid QC methods. Perform method qualification to support of sterility and endotoxin testing. Develop, revise and review SOP's. Identify, author, and review change controls for the QC team. Lead and support continuous improvement projects such as rapid testing technology, automated testing technology, technical QC studies, LEAN, and 5S. What you have to offer.
Requirements: Bachelor's or Master's degree in the sciences and 0-2 years of experience in a GMP lab setting, preferably in a QC Microbiology lab setting, or suitable coursework in Microbiology. Experience using micropipettes for aseptic fluid transfers. Experience with safe lab practices and handling of biological material. Experience in aseptic technique and behaviors, such as those required for GMP gowning and in GMP clean rooms. Excellent interpersonal, verbal and written communication skills. Ability to organize workload and work independently and collaborate within teams, as needed, for timely completion of objectives. Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities. Ability to lift 25 lbs. Proficient in MS Word, Excel, and Power Point. Preferred Requirements: Knowledge of GMPs, GDPs, and Quality Control processes within a QC Microbiology laboratory. Experience in leading and/or participating in performance qualification for environment (i.e. EMPQ) and utility qualifications. Experience in conducting environmental monitoring and/or GMP utility investigations that resulted in assignable root cause and effective CAPA. Experience in conducting risk assessments to support QC operations. Knowledge in pharmacopoeia and regulatory requirements related to GMP QC testing. Experience regulatory contamination control requirements. Proven ability to lead cross-functional projects from initiation to completion. Benefits for you: BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.
If you are unable or limited in your ability to use or access BioNTech's online application tools due to a disability, you can request reasonable accommodations by calling ******** or by e-mailing . Thank you for your interest in BioNTech.
