Senior Research Associate, Process Development, Cell Therapy

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 Senior Research Associate to expand our cell therapy process development team.With the guidance of process development senior staff, this researcher will develop and optimize manufacturing processes for gene-modified cell products to advance

Resilience's biomanufacturing platforms and the clinical programs of Resilience's partners.

Job 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.

Minimum Qualifications

• 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 Qualifications

• 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.

Other Ideal Personal Characteristics

• Intellectually curious with an open, inquisitive mind regarding the future of medicine and biomanufacturing.

• Collaborative style, with an ability to build consensus among internal and external stakeholders.

Sponsorship or support for work authorization, including visas, is not available for this position.

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.