- Gaithersburg, Maryland
- Work experience
- Research, development, teaching
Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary 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.
We are seeking a self-motivated, detail-oriented Associate Scientist to join the Analytical Development (AD) team to enable process development, stability, and lot release testing and characterization of autologous cell therapy products. The AD team is responsible for developing and qualifying phase-appropriate analytical methods and supporting technology transfer from AD to QC. Team members participate in process and analytical method investigations, draft SOPs/MPRs, method development reports, qualification protocols, and training runs. The member must be comfortable working in a fast-paced work environment where workload and priorities may change.
Here, you’ll achieve greatness.
Design, develop, and perform analytical methods utilizing different immunology platforms with an emphasis on flow cytometry based methods (e.g. immunophenotyping, cell characterization, transduction efficiency, WBC/RBC determinations)
- Preparation, testing, and maintenance of cell banks and controls
- Transfer analytical methods to Quality Control
- Maintain and troubleshoot instrumentation commonly utilized by the team
- Collaborate with both internal teams and external groups to advance scientific capabilities
- Analyze and present results within the team and to broader scientific groups
- Draft SOPs, reports, and presentations
- Maintain a high standard of experimentation and record keeping
- Work productively in a team environment and independently to deliver against timelines
What you have to offer.
- Minimum requirements: BS in Biology or related discipline with 5 plus years of laboratory experience, industry experience is preferred
- Experience working within CMC and tech transfer (e.g. analytical development and/or QC) for cell therapy products is strongly preferred
- Excellent aseptic technique is required
- Primary immune cell culture experience is a plus
- Experience performing multicolor flow cytometry is required
- Knowledge of protein-based assays (e.g. ELISA), molecular platforms (e.g. qPCR, ddPCR), and/or cell-based assays is a plus
- Experience employing quality by design (QbD), design of experiments (DOE), and statistical approaches to method development is a plus
- Demonstrated ability to develop, qualify/validate and transfer analytical methods to clinical/commercial QC is preferred
- Ability to work on multiple projects simultaneously to support pipeline is required
- Ability to independently design, conduct, and report experiments is required
- Strong collaboration skills and ability to work well with others is required
- Good organizational, verbal and written communication skills
- Proficient in MS Word, Excel, PowerPoint
Preferred requirements; MS in Biology or related discipline and 5 plus years of laboratory experience, industry experience is preferred. Experience using JMP or other statistical software. Demonstrated ability to develop, qualify/validate and transfer analytical methods to clinical/commercial QC is preferred and knowledge of protein-based assays (e.g. ELISA), molecular platforms (e.g. qPCR, ddPCR), and/or cell-based assays.
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!