QC Analytical Technical Lead *
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
QC Analytical Technical Lead (2 positions)*
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.
BioNTech is seeking two highly-motivated QC Analytical Technical Leads to support and lead design, planning, and execution of method validation/qualification/suitability for Flow cytometry, ELISA, PCR, cell-based assay, and other applicable methods to support tech transfer of new processes. Support Equipment qualifications (IQ, OQ, PQ) required in QC Analytical operations. Troubleshoot testing or technical issues as it relates to methods, equipment or instruments.
Here, you’ll achieve greatness.
- Represent QC Analytical as a technical SME in cross-department and cross-site teams.
- Support design and execution of QC Stability studies for multiple products.
- Support design of in-process control and release testing strategy for multiple cell therapy products.
- Design and execute technical studies to support current/proposed lab operations and continuous improvement.
- QC Lead in drafting and supporting risk assessments for multiple cell therapy products.
- Lead the technical training function for the QC Analytical team, including designing on-the job performance training (OJT), scheduling, execution, and continuous improvement.
- Perform a variety of analytical assays, including molecular and cell-based assays.
- Author, revise and review SOPs, equipment validation, method qualification, technical study protocols/reports, and risk assessments.
What you have to offer.
- Minimum requirements; Bachelor's Degree in sciences with 6 plus years of experience in a QC Analytical 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.
- 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.
Preferred requirements; Experience with Flow cytometry, ELISA, PCR, molecular and cell-based assays, and other applicable methods. Proven record in leading strategy and execution of QC method qualification and method tech transfer. Experience working in GMP QC Analytical laboratories that support aseptic sterile GMP manufacturing. Experience designing and executing risk assessments to support current and proposed QC testing operations.
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 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!