Supervisor, QC Bioassay - Resilience

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 Responsibilities:

• Responsible for all cGMP related bioassay in-process, release and stability testing.

• Manage team QMS records (deviations, CAPAs, change controls) to meet timelines, including owning records as necessary.

• Ensure staff is properly trained and maintains appropriate training levels to complete tasks. Actively train analysts when appropriate.

• Perform logbook and data package reviews.

• Lead audit tours, identify and train testing subject matter experts for audits, and own audit findings (responses and associated CAPAs).

• Direct the day-to-day activities of the team.

• Track and monitor execution of method lifecycle activities assigned to team.

• Provide management and development of the bioassay team through career development discussion and performance reviews.

• Interface with the Head of Quality Control to ensure cGMP compliance and documentation.

• Collaboration with supply chain, digital, and other operations-related functions.

• Own daily tier meetings including facilitation, completion of actions, and maintenance of tier board.

• Ensuring a strong quality and safety culture is maintained within the Bioassay laboratories.

• Identify, lead, and implement continuous improvement projects to ensure adherence to cGMP and regulatory regulations.

• Monitor and maintain key identified metrics. Use metrics to identify continuous improvement projects for area.

• Ensure instrumentation is maintained properly via proper periodic maintenance and calibration activities. Coordinate these efforts with appropriate personnel.

• Mentor team in technical writing skills for deviations, standard operating procedures, test methods, protocols, and reports.

• Ensure subject matter experts are identified for each testing platform and act as subject matter expert when necessary.

Minimum Qualifications:

• Experience working in biotech or pharmaceutical industry.

• Model leadership and effective communication skills.

• Experience in CGMP Bioassay activities.

• Experience in cell based, non-cell based, and other relevant bioassay methods.

• Experience with quality systems supporting CGMP activities.

Preferred Qualifications:

• Previous supervisory experience.

• Bachelor of Science degree.

This position may also include the following conditions:

Physical work:

• This role is primarily a Sedentary role. This can include exerting up to 10 pounds of force to move objects.

• Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, general observations of facilities, etc.

• Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing.

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

Exposure to the following:

• 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 $75,000.00 - $112,500.00 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.