Job Description
Our large pharmaceutical client in Spring House, PA is seeking a Scientist to join the Decisional Analytics group within Cell Therapy API Development. This group is responsible for developing rapid, robust, and high-throughput analytical platforms to support multiple cell therapy programs, advancing them from early-stage development to late-stage clinical readiness. The successful candidate will leverage their technical expertise and experience to design, optimize, and execute assays to evaluate the attributes and quality of lentiviral vectors and CAR-T cell therapy processes and products, contributing to the cell therapy manufacturing platform. This is a unique opportunity to work within a cross-functional matrix environment supporting industry-leading autologous cell therapy programs that have made significant contributions to advancing human health and providing quality therapeutics to patients.
Key Responsibilities:
• Lead efforts within program teams to design, optimize, and execute bioanalytical methods for assessing lentiviral and cell therapy drug products during both process development and product testing.
• Execute and optimize lentiviral vector characterization assays, including infectious titer, ELISA-based physical titer, MSD assay, residual host cell DNA and protein analysis, potency assays, and safety characterization through VCN assays.
• Contribute to the development of novel, automated bioanalytical platforms to improve the efficiency and throughput of existing analytical assays.
• Participate in routine lab operations, including lab maintenance, safety inspections, equipment maintenance, reagent qualifications, and other duties as required.
• Analyze high-volume data and present research findings through written reports and oral presentations.
• Collaborate with cross-functional teams, both internal and external (including contractors and different departments), to support the success of projects.
• Lead or mentor other scientists on process, techniques, or tasks as needed.
• Ensure data integrity and compliance with laboratory operations, including adherence to SOPs for data recording, equipment usage, and laboratory safety standards.
• Maintain detailed, GxP-compliant records and notebooks, ensuring safety and environmental requirements are met.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• MS/BS/BA in Biological Sciences, Biochemistry, Chemical Engineering, or a related scientific discipline.
• 2+ years of industry experience in analytical development
• Hands-on expertise in mammalian cell culture, including primary and immortalized cell lines, and lentiviral vector characterization.
• Experience developing analytical assays with a focus on lentiviral vector characterization, including ddPCR, qPCR, ELISA, MSD assays, immune assays, flow cytometry
• Strong ability to design and execute experiments with minimal technical supervision, perform data analysis, and troubleshoot complex problems.
• Proficiency with statistical tools to interpret and analyze analytical assay data.
• Ability to manage multiple projects simultaneously and thrive in a fast-paced laboratory environment.
Nice to Have Skills & Experience
• Familiarity with autologous cell therapy processes, in vivo CAR and viral vector analytical methods.
• Experience with cell therapy manufacturing steps, including T cell selection, activation, transduction, and expansion.
• Experience maintaining electronic records using electronic lab notebooks (ELNs) and Laboratory Information Management Systems (LIMS).
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.