QC Specialist I/II*
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
QC Specialist I/II*
This position is based in Gaithersburg, MD at our newly formed clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US. Everyone at BioNTech is grounded by one common goal to develop the next generation of immunotherapies to improve clinical outcomes for patients and usher in a new era of individualized medicine.
Here, you’ll achieve greatness.
- Execute analytical methods/SOPs and operate equipment and instruments supporting ELISA, qPCR, ddPCR assays, cell bioassays, and Flow Cytometry.
- Monitor method performance, product quality, reagent usage, invalid rate and/or stability data.
- Support technical transfer of analytical methods, including comparability testing and co-qualification.
- Support 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 review of QC documentation and logbooks.
- Revise, and review SOPs, technical protocols, and technical reports.
- Support QC training activities.
- Support inspection readiness activities.
- Lead and participate on teams to support new processes and improve existing processes in the QC labs.
- 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
- Level I: 0-2 plus years of experience in a GMP/QC lab setting
- Level II: 2-5 plus years of experience in a GMP/QC 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 knowledge of GMPs, GDPs, SOPs and Quality Control processes within a regulated QC laboratory.
- Preferred knowledge in compendia and regulatory requirements for QC testing and validation pertaining to the pharmaceutical industry.
- Familiar with analytical techniques such as Flow Cytometry, ELISA, PCR, cell bioassays and other applicable methods to the testing of biopharmaceuticals.
- Familiar with requirements and strategies to support technology (tech) transfer of analytical methods.
- Preferred knowledge of Quality Systems, including deviations, CAPA, change control, and document management systems.
- 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, Power Point and other applications.
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & 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 firstname.lastname@example.org.
*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!