QC Microbiology Technical/ Team Lead*
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
QC Microbiology Technical/ Team Lead*
BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.
Based in Gaithersburg, MD we are seeking a highly motivated Quality Control Microbiology Technical Team Leads to support equipment qualifications (IQ, OQ, PQ) required in QC Microbiology operations. Troubleshoot testing or technical issues as it relates to methods, equipment or instruments. Design, execute and lead Rapid Sterility and Endotoxin method validation/qualification/suitability to support tech transfer of new processes. Author, revise and review SOPs, equipment validation, method qualification, technical study protocols/reports, and risk assessments. Perform data review of QC Microbiology sampling and testing operations to assure accurate records of work performed and documentation of test results per good documentation practices (GDP).
Here, you’ll achieve greatness.
- Represent QC Microbiology as a technical SME in cross-department and cross-site teams.
- Design, support, and lead QC testing related to Aseptic Process Validation (APV) and Aseptic Operator Validation (AOQ).
- Support design of in-process control and release testing strategy for multiple cell therapy products.
- Design and execute microbiological technical studies to support current/proposed lab operations and continuous improvement.
- QC Lead in drafting and supporting contamination control risk assessments for multiple cell therapy products.
- Design, plan, execute, and lead EMPQ for existing facility, changes to existing facility, and new facility build-outs.
- Lead the technical training function for the QC Microbiology team, including designing on-the job performance training (OJT), scheduling, execution, and continuous improvement.
What you have to offer.
- Minimum requirements; Bachelor’s Degree with 5 plus years of experience in a QC GMP lab setting.
- 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.
- Experience designing and executing risk assessments to support current and proposed QC testing operations. Proven experience in design and completion of method qualifications and EMPQ. Ability to participate in regulatory inspections and convey appropriate technical information clearly and concisely. Ability to exercise sound judgement and decision making to ensure compliance with regulations under aggressive timelines
- Lead strategy and implementation of rapid and automated technologies, including rapid sterility and automated/rapid EM.
- Lead strategy and implementation of clean utilities, including purified water and clean gases/air.
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!