Supervisor, Quality Control

General Company Description

RESILIENCE (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.

RESILIENCE (National Resilience, Inc.) is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans

For more information, visit www.resilience.com.

Position Summary & Role (general description of the role, e.g., expectations, key milestones, impact)

Job Responsibilities (core responsibilities; include people management if applicable)

• Schedule testing for QC personnel, including in-process testing support, intermediates, excipients, drug products and biological samples.
• Monitor and maintain key identified metrics for team
• Track, schedule and execute analytical method development and validation.
• Maintain analytical instruments. Coordinate maintenance work with appropriate personnel.
• Mentor direct reports in technical writing.
• Assist in understanding and/or solve technical problems related to QC issues.
• Lead complex investigations for QC issues.
• Write and assist in writing Standard Operating Procedures (SOPs), Test Methods (TMs), protocols and reports.
• Review and interpret analytical work and test reports.
• Act as primary client contact for designated clients including attending weekly meetings, providing updated testing status, and providing released results as requested.
• Assist in keeping the laboratory a safe and clean environment through scheduling housekeeping, performing walkthroughs and correcting issues.
• Observe GMPs and safety rules.
• Assist in training personnel, including scheduling training and performing training.
• Manage and coordinate analytical and QC personnel, activities, and timelines.

Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)

• Bachelor’s degree in Chemistry, Biology, Microbiology or other related science degree
• 2-5 years of chemistry lab experience in life sciences industry
• Experience working with HPLC, LC-MS, basic wet chemistry techniques
• Experience with biological sample extraction
• Experience in method development and validation of pharmaceuticals.
• Technical writing experience (i.e.. Deviations, SOPs, test methods, protocols and reports)
• Experience with cGLP, cGMP, and QA procedures.
• Good communication and organizational skills

Physical Requirements: (rows or statements that are not required to perform the duties of the position)

This job requires the employee to perform the following physical activities:

• Climbing
• Balancing
• Use of fingers
• Stooping
• Kneeling
• Repetitive motion
• Crouching
• Reaching
• Standing
• Grasping
• Walking
• Pushing
• Hearing
• Pulling
• Lifting
• Talking

This job requires the employee to work in the following conditions:

• Temperature changes
• Activities occur inside

This job requires exposure to the following:

• Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
• Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 2, including for emergency response.
• Hazards: packaging, shipping, handling, or decontamination of infectious agents assigned to risk group 3, including for emergency response.
• Laboratories, production rooms, waste holding areas, or other facilities where infectious agents are or may be handled or stored.
• Physical vibration.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.

This job requires the employee to perform the following type of physical work:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

This job requires the following visual acuity requirements:

• preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.

This job requires routine or periodic use of respiratory protection:

• Loose-fitting respirators, such as hood or helmet style Personal Air Purifying Respirators (PAPR).
• Tight-fitting respirators, such as half-masks or full facepieces which must seal to the face or neck.

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 annualized base pay hiring range for this position is $72,000.00 - $100,500.00. 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.