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Resilience · 23 hours ago

Senior Research Associate, Process Development, Cell Therapy

East Norriton, PA

Full-time

Onsite

Mid, Senior Level

$80K/yr - $110K/yr

3+ years exp

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. They are seeking a talented Senior Research Associate to expand their cell therapy process development team, focusing on developing and optimizing manufacturing processes for gene-modified cell products.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Participate in development studies with internal and external collaborators to characterize and refine biomanufacturing platforms, develop and incorporate new technologies, and/or advance the clinical programs of Resilience’s partners

Perform development studies including optimization of cell isolation, cell culture, cell transduction, gene editing and cell cryopreservation processes across a range of cell types, including but not limited to: T, B and NK cells

Contribute to studies evaluating raw materials and developing proper analytical controls to screen and select those that are critical to the manufacturing process

Contribute to studies evaluating innovative manufacturing & analytical technologies for engineered T cell manufacturing to improve process efficiency

Author technical and scientific documents including but not limited to technical procedures, study protocols and reports, and development batch records

Work with senior staff in process development to contribute to the creation of IND enabling activities

Participate in activities leading to the preparation of CMC documents for regulatory filings

This position will require some work on weekends and outside of regular business hours

Qualification

Cell cultureCell processing methodsGMP/cGMP practicesCell therapy developmentAnalytical toolsStatistical softwareRecord keepingCollaborative styleIntellectual curiosityCommunication skills

Required

Experience with primary cell culture and cell processing methods

Knowledge of or prior experience with cell therapy product and/or process development

Knowledgeable in GMP/cGMP practices and regulatory compliance

Strong record keeping skills; excellent oral and written communication skills

Comfortable in a fast-paced small company environment, working with minimal direction and able to adjust workload based upon changing priorities

Preferred

Bachelor's or Master's degree in immunology, cell biology, bioengineering or a related field

3-5 years of life sciences development experience in an industry setting

Knowledge of cGMP Quality Systems and electronic laboratory notebooks

Experience with analytical tools such as flow cytometry, cell counting and size measurement, cell viability assessment, bioprocess analyzers or similar methods

Familiarity with statistical and data presentation software applications such as Minitab, JMP, and/or Power BI