Our large pharmaceutical client is seeking a Sr. Associate Scientist to join a growing team focused on cell therapy process development for the
development of innovative treatments for cancer. The position is a key part of the growing API Cell and Gene Therapy organization, Within this organization, the Therapeutics Development & Supply (TDS) group is seeking a highly motivated and collaborative Sr. Associate Scientist to join the Decisional Analytics: Cell Therapy API Development team. This group is responsible for generating rapid and robust, high throughput analytical platforms that support multiple cell therapy programs from early to late-stage clinical readiness for rapid progression of process development. Utilizing technical experience and knowledge, the successful candidate will be accountable for designing, optimizing, and executing assays to assess the attributes and quality of viral vectors and CAR-T cell therapy processes and products as a part of cell therapy manufacturing platforms. The chosen candidate will have the opportunity to work in a cross-functional matrix environment supporting industry leading Autologous/Allogeneic cell therapy programs that has brought numerous quality therapeutics to patients and made significant contributions to human health.
Key Responsibilities:
Actively participate with the program teams and lead efforts to design, optimize, and execute bioanalytical methods to assess Lentiviral and Cell therapy drug products during process development and product testing.
Support, develop and optimize CAR-T process development platforms with a focus on rapid decisional analytics.
Apply scientific expertise to evaluate alternative technologies, troubleshoot immunoassays, and write technical documents involving both Autologous and Allogeneic CAR-T programs.
Support CAR-T process and development, perform cell culture and decisional analytics assays associated with these activities as required.
Routinely support non-clinical and clinical study sample analytical testing, if required.
Participate in routine lab operations (Lab maintenance, safety inspections, etc.), equipment maintenance, reagent qualifications, and/or other duties.
Analyze high volume data, present research findings and data to the group through both written and oral communication.
Interact and collaborate with cross functional teams consisting of both internal and external groups (different departments, contractors).
Responsible for leading or training other scientists regarding process, techniques, or tasks as required.
Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording and laboratory equipment.
Maintain detailed records and notebooks in a GXP compliant manner, safety, and environmental requirements.
Work in a team environment, as well as contribute individually to meet project timeline and objectives.
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Bachelor's or Master's Degree in Biology, Immunology or other relevant scientific field
2+ years of industry experience in the lab
Functional expertise and hands on laboratory experience in mammalian cell culture, aseptic cell culture and handling for primary and immortalized cells
Developing analytical assays with a particular focus on immune assays (Flow cytometry, potency and cell killing assays, ELISA, MSD platform, qPCR/ddPCR)
Ability to design and execute experiments with minimal technical supervision, skills to perform data analysis and troubleshooting
Experience with statistical tools to interpret and analyze analytical assays
Ability to handle multiple projects and a fast-paced lab environment
Deep intellectual curiosity, and excellent communication, interpersonal and collaboration skills
Familiarity with autologous cell therapy processes and viral vector analytical methods
Familiarity and/or hands on experience with cell therapy manufacturing steps, i.e. T cell selection, activation, transduction and expansion
Experience maintaining electronic records via electronic notebooks, LIMS systems is preferred
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.