Microbiology Technical Lead, Quality Control
Location
Gaithersburg, MD | United States
Job description
Microbiology Technical Lead, Quality Control
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 Microbiology Technical Lead is responsible for partnering with managers and site subject matter experts in driving technical functions for the QC Microbiology team, including owning EMPQ planning and execution, rapid and automated system validation, and method validation, to support GMP manufacturing operations.
Primary Responsibilities include:
- Lead and represent QC Microbiology as a technical SME within cross-functional teams, including execution of EMPQ, Aseptic Process Simulation, disinfectant efficacy, and contamination control programs.
- Lead implementation of next generation rapid and automated technologies, supporting sterility, EM, and endotoxin tests.
- Lead generation of risk assessments to support QC operations.
- Support design of in-process control and release testing strategy for multiple cell therapy products.
- Design, author, and execute microbiological technical studies to support current/proposed lab operations and continuous improvement.
- Support the technical training function, including design of effective on-the-job performance training, training execution, and continuous improvement.
- Review GMP documentation for the QC Microbiology team.
- Support generation and revision of new SOPs and testing methods.
- Support microbial excursions, lab investigations, deviations, CAPA, and effectiveness verification.
What you have to offer.
Requirements:
- Bachelor’s or Master’s Degree with 6 plus years of experience in a QC GMP Microbiology lab.
- Experience with safe lab practices and the handling of biological material.
- Knowledge of GMPs, GDPs, and regulatory compliant Quality Control processes.
- Experience in leading cross-functional projects from initiation to completion.
- Experience in leading and/or participating in EMPQ and utility qualifications.
- Experience in conducting microbial excursion investigations that resulted in assignable root cause and effective CAPA.
- Strong attention to detail and the ability to work cross-functionally.
- Excellent communication and organizational skills.
Preferred Requirements:
- Experience in Rapid Sterility, Endotoxin testing, clean utilities, and QC microbiology lab operations.
- Experience in rapid and automated microbial method validation.
- Experience in designing and executing risk assessments that determine risk base approaches to QC operations.
- Experience in authoring and executing microbial method validation/qualification.
- Experience in supporting regulatory inspections, such as conveying clear and concise technical information to auditors.
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Benefits for you:
BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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 – could be convinced to use the word “competitive.”
- Tuition Reimbursement & Student Loan Assistance Programs
- Wellbeing Incentive Platforms & Incentives
- Professional Development Programs
- Commuting Allowance and subsidized parking
- Discounted Home, Auto & Pet Insurance (consolidate)
…and more! More details to be shared.
Have we kindled your pioneering spirit?
Then apply now for our location Gaithersburg and simply send us your application documents using our online form.
* BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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