Senior Specialist, Quality Control

Biontech Ag - Gaithersburg, MD

Part-time - Mid Level

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

As a Senior Specialist in Quality Control at BioNTech, you will play a crucial role in ensuring that our products meet rigorous testing requirements and that our laboratory operations comply with all regulatory standards. You will support the day-to-day operations of the QC analytical lab, executing analytical methods and operating various equipment and instruments that are essential for conducting ELISA, qPCR, ddPCR assays, cell bioassays, and Flow Cytometry. Your expertise in these areas will be invaluable as you serve as a subject matter expert for QC analytical methods. In this position, you will be responsible for authoring and revising Standard Operating Procedures (SOPs), test methods, technical protocols, and technical reports in compliance with current Good Manufacturing Practices (cGMP). You will also support the routine review of test data, logbooks, and related documents to ensure accuracy and compliance. Monitoring method performance, product quality, reagent usage, and stability data will be part of your daily responsibilities, as will supporting the technical transfer of analytical methods, including comparability testing and full qualification of methods. You will lead and author quality system records, including deviations, lab investigations, Out of Specification (OOS) reports, Corrective and Preventive Actions (CAPA), and change control documentation. Additionally, you will support the qualification of new lab equipment and perform routine maintenance of lab spaces. Training other QC staff on analytical methods and procedures will also be a key aspect of your role. Participation in regulatory inspection readiness activities and leading teams to support new processes, continuous improvement, and LEAN initiatives will be expected. You will also be involved in various ad-hoc projects to support site and QC team objectives, making this a dynamic and engaging position within our organization.

Responsibilities

• Support the day-to-day operation of the QC analytical lab to assure products meet testing requirements and laboratory operations comply with regulatory requirements.
• Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays, and Flow Cytometry.
• Serve as a subject matter expert of QC analytical methods in the areas of ELISA, qPCR, ddPCR assays, cell bioassays, and Flow Cytometry.
• Author and revise SOPs, test methods, technical protocols, and technical reports in compliance with cGMP.
• Support routine record review of test data, logbooks, and related documents associated with testing.
• Monitor method performance, product quality, reagent usage, invalid rate, and/or stability data.
• Support technical transfer of analytical methods, including comparability testing, co-qualification, and full qualification of methods.
• Lead and author quality system records, including deviations, lab investigations, OOS, CAPA, and change control.
• Support QC equipment qualification for new lab equipment and perform routine maintenance of lab equipment and lab spaces.
• Support inventory and qualification of QC raw materials.
• Train other QC staff on QC analytical methods and procedures.
• Participate in regulatory inspection readiness activities, as required by Management.
• Lead and participate in teams to support new processes, continuous improvement, LEAN, and 5S efforts.
• Perform other duties as required, including ad-hoc projects to support site and QC team objectives.

Requirements

• Bachelor's degree in sciences with 6+ years of experience in a GMP/QC lab setting or Master's degree in sciences with 4 years of experience in a GMP/QC lab setting.
• Experience in analytical techniques such as Flow Cytometry, ELISA, PCR, cell bioassays, and other applicable methods for the testing of biopharmaceuticals.
• Knowledge of GMPs, GDPs, SOPs, and Quality Control processes within a regulated QC laboratory.
• Knowledge of compendia, regulatory requirements for QC testing, and qualification/validation pertaining to the pharmaceutical industry, specifically cell therapy.
• Familiarity with requirements and strategies to support technology transfer of analytical methods.
• Preferred knowledge of Quality Systems, including deviations, CAPA, change control, and document management systems.
• Experience with safe lab practices and the handling of biological material.
• Strong attention to detail and the ability to work cross-functionally.
• Excellent communication and organizational skills.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon multiple projects and changing priorities.
• Proficient in MS Word, Excel, PowerPoint, and other applications.

Benefits

• 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