Analyst II, Quality Control

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:

We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products. This includes performing analytical methods, data review and trending, and implementation of GMP operational support systems ensuring a compliant Quality Control lab.

The candidate will interface with multiple Quality Control functions in support of method qualification, transfer, and validation activities. In addition, the individual will collaborate with Quality Assurance, IT, Manufacturing, and other cross-functional teams as required.

A strong cGMP, operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role.

This position will require hands on laboratory time.

Position Responsibilities:

• Perform cGMP analytical testing (bioassay, flow cytometry, qPCR, ELISA, and UPLC)

• Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.

• Author, review, and/or approve SOPs/policies and technical reports with general guidance

• Support laboratory deviations and investigations (IA, OOS, AR).

• Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)

• Execute phase-appropriate test method validation protocols as needed

Minimum Qualifications:

• Working experience in a cGMP/GxP environment

• Hands-on experience in flow cytometry, qPCR, and other bioanalytical methods such as ELISA and UPLC methods

Preferred Qualifications:

• BS in a biotechnology discipline

• Superb organizational, analytical, and communications skills and "do what it takes" attitude

• A passion for addressing the critical unmet medical needs of patients

• Self-directed individual who can work with limited direction in a fast-paced, goal-oriented environment

• Demonstrated knowledge of cGMP/ICH/FDA/EU regulations.

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 $65,000.00 - $87,500.00 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.