Senior QC Microbiologist*
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
Senior QC Microbiologist
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.
Here, you’ll achieve greatness.
- Conduct investigations regarding procedural deviations, out of specifications (OOS) results, environmental monitoring, utilities, and address and manage deviations related to microbiological procedures.
- Determine and execute corrective and preventative actions (CAPA) as determined for investigations and OOS.
- Perform data entry and data verification of EM and Utilities. Author and review final trend reports. Support QC equipment qualification and perform method qualification to support implementation of sterility and endotoxin testing.
- Develop, revise and review SOP’s.
- Identify, author, and review change controls for the QC team.
- Review QC raw data, such as testing and logbooks.
- Support data management requirements for the team, including data entry and trending of data utilizing Excel, LIMS, or other trending software.
- Perform microbiological assays and operations such as Rapid Sterility, Rapid Endotoxin, Gram Stain, Microbial Identification, Growth Promotion, Bioburden, and Plate Reading.
- Perform routine maintenance of lab equipment and lab spaces.
- Lead and participate on teams to support new processes and improve existing processes in the QC labs.
- Perform environmental monitoring (EM) of GMP classified cleanrooms.
- Perform sampling and testing (e.g. bioburden) of utilities, including purified water and compressed gases.
- Lead and support LEAN and 5S efforts as required.
- Perform other duties as required, including ad-hoc projects to support site and QC team objectives.
What you have to offer.
- Master’s or Bachelor’s degree in sciences and
- 4-6 plus years of experience in a GMP QC Microbiology 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
- Preferred experience in aseptic technique and clean room operations.
- Preferred experience in conducting environmental monitoring investigations.
- Preferred knowledge of Quality Systems, including deviations, CAPA, change control, and document management systems.
- Preferred knowledge of GMPs, GDPs, SOPs and Quality Control processes within in QC Microbiology laboratory.
- Preferred experience in method validation and qualification.
- Preferred knowledge in pharmacopoeial, and regulatory requirements for QC testing and validation pertaining to the pharmaceutical industry.
- Ability to aseptically gown to clean room standards (ISO 5- ISO 8) and lift approximately 25 lbs.
- Proficient in MS Word, Excel, Power Point and other applications.
- 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 changing priorities.
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!