Senior Analyst II, Quality Control (Potency)

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

Position Summary:

The Senior Analyst II, Quality Control (Potency) will report to the Manager, Quality Control of the Quality Control Analytical team at the Resilience Philadelphia site. This motivated and organized individual with strong people skills provide technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organization.

She/he will work closely with the QC leadership team, Process Analytical Development (PAD) and Manufacturing team to ensure that all required testing is performed, meeting partner needs in compliance with standard operating procedures and testing methods. She/he will be responsible for timely execution of qualification/validation protocol and technical reports, test review, and approval of results for in process, bulk, final product, and stability samples. The Senior Analyst II, Quality Control (Potency) will partner with Analytical Development to coordinate the transfer and qualification/validation of new assays in the QC Analytical Laboratory. 

Position Responsibilities:

• Perform testing on lentiviral vector and CAR-T products using protein-based assays, molecular methods, and cellular assays.

• Design and execute method qualifications, validations, and transfers.

• Collaborate with Process Analytical Development (PAD) and manufacturing in support of testing and investigations.

• Investigate OOS, OOT, and Atypical events and develop/implement preventative and corrective actions.

• Author SOPs, method, protocols, training materials, and reports in alignment with applicable cGMPs, business standards, and intended use.

• Analyze, document, and report experiment data in accordance with Resilience requirements.

• Document work in accordance with cGMPs, establish business processes and applicable procedures.

• Mentor and train junior analyst on potency testing and cell line maintenance.

• Other activities as assigned.

NOTE: This role requires a visual acuity test in order to certain methods that require assessing color and clarity.

Minimum Qualifications:

• Prior experience and in-depth knowledge of cell-based potency assays and other functional bioassays that are used for in-process, drug product, and stability testing.

• GMP experience required

• Knowledge of general analytical methods;

• Ability to thrive in ambiguous or complex situations

• Highly motivated and self-directed

• Thrives in matrix environment

• Excellent interpersonal, verbal and written communication skills

Preferred Qualifications:

• B.S. in relevant discipline (immunology, cell biology, or related field)

• 5 or more years relevant life science experience

• Experience in mammalian cell culture

• Knowledge of cell therapy analytical methods

• Background in Cell Therapy/Gene Therapy

This position may also include the following conditions:

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens

• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.

• Packaging, transporting, and shipping of infectious or potentially infectious substances

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

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 - $137,500.00 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.