Scientist II, Analytical Development, Cell Therapy

National Resilience

National Resilience

East Norriton, PA, USA
Posted on Friday, August 23, 2024

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Resilience is seeking a talented Scientist II to join the Cell Therapy Analytical Development team. This team is responsible for the design, development, and implementation of assays to advance the company’s novel cell therapy programs. This researcher should have a background in assay development, preferably in cellular and molecular immunology and immune oncology, while also possessing strong interpersonal skills and the ability to work collaboratively with other groups within the organization. This scientist will work collaboratively across multiple internals teams and with Resilience's partners to develop and optimize analytical assays for cell therapy manufacturing projects and high-throughput gene projects.

Job Responsibilities

  • Responsibility for method development, qualification, validation, and transfer activities for analytical methods
  • Development, optimization and troubleshooting of new methods to improve capabilities and throughput in the analytical development laboratory
  • Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable GxP, safety, and environmental requirements is expected
  • Compiling data for review and discussion within the Cell Therapy team
  • Technology transfer of analytical methods to other departments and support analytical method qualification and/or validation if needed
  • Routine maintenance and calibration of analytical equipment
  • Providing technical support to QC laboratories, and assisting in investigations
  • Providing support to other site in method development, if necessary
  • Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
  • Utilize digital technology (Benchling/ELN) for recording lab activities

Minimum Qualifications

  • Extensive experience using mammalian cell culture techniques, potency assays and common immunological methods (ELISA, ELISpot, cytokine assays, multi-color flow cytometry, etc.)
  • Prior experience in RNA/DNA isolation and molecular biology assays (qPCR, ddPCR, qRT-PCR)
  • Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters
  • Good organizational skills and the ability to multitask
  • A self-starter and team player who can balance the velocity of startup environment with the quality and rigor of a clinical regulatory environment
  • Excellent oral and written communication skills

Preferred Qualifications

  • Ph.D. in Biochemistry, immunology, virology, biological science, or related discipline with at least 3 years of experience in biopharmaceutical development, or M.S. with at least 8 years of experience in biopharmaceutical development. Experience in in-vitro potency assay development for Cell & Gene therapy products
  • Experience with analytical or statistical software, e.g., Flowjo, Softmax Pro, GraphPad Prism
  • Gene editing (i.e. CRISPR) experience
  • Working knowledge of cGMP Quality systems
  • Demonstrated experience on the MiSeq, NextSeq or long-read sequencers
  • Familiarity with cell and gene therapy concepts and product development/manufacturing workflow.
  • Experience handling multiple virus families and/or multiple viral vectors
  • Strong analytical problem solving, planning and organizational skills
  • A good communicator with a collaborative mindset.
  • Ability to work independently in a fast-paced environment with minimal supervision.
  • Open-minded and willing to learn and execute new protocols, techniques, and workflows.
  • Willingness to work some after hours and weekend hours if necessary.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100,000.00 - $145,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.