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Resilience

Biologics and sterile injectables CDMO

Analyst 2 - Quality Control, Night Shift

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USA

About the Job

Requirements

  • Working knowledge of current Good x Practice (cGxP) requirements and strong familiarity with production operations.
  • Good problem-solving skills.
  • Proficiency in mathematics, laboratory skills, and computer skills, with understanding of basic statistics and quality control terminology.
  • Ability to work a rotating 12-hour night shift, including scheduled weekends and holidays; provide 24/7 on-call support as needed.
  • Ability to work onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5) aseptic areas; gowning and adherence to aseptic behavior requirements are required for cleanroom activities.
  • Ability to stand, walk, bend, and reach for extended periods and lift up to 25 pounds.

Responsibilities

  • Perform testing on finished products, raw materials, stability samples, in-process materials, and water samples.
  • Maintain and troubleshoot testing equipment.
  • Support laboratory investigations and quality control method and standard operating procedure updates.
  • Execute laboratory test protocols supporting development and validation activities.
  • Review quality control data.
  • Provide and follow up on ideas for continuous improvement in laboratory processes.
  • Learn procedures and perform analyses while taking direction and correction.
  • Complete assigned tasks and self-assign work without immediate supervision when appropriate.
  • Handle hazardous materials knowledgeably and safely.
  • Operate equipment in classified and non-classified areas, including Class 100 aseptic environments and laboratory settings.
  • Collaborate and communicate within the team and with operations groups and quality assurance.
  • Perform environmental monitoring tasks to support regulatory requirements at a sterile manufacturing site, including data review and on-the-floor sampling.

Desired Qualifications

  • Bachelor’s degree in chemistry, biology, or a related field.
  • Quality control chemistry laboratory experience in the pharmaceutical industry.
  • Working knowledge of laboratory equipment, including high-performance liquid chromatography (HPLC), laboratory operations, and safety.

About the Company

Resilience

Biologics and sterile injectables CDMO

Resilience is a North American CDMO focused on biologics and sterile drug products. It provides end-to-end services from development through commercial production, including biologics development and drug substance manufacturing, aseptic fill/finish, device assembly, packaging, logistics, regulatory support, and tech transfer, all coordinated via a stage-gate process and a digital quality management system. It differentiates itself with North American-based, integrated biologics and sterile capabilities, a focus on sterile injectables and device assembly, and recent expansion into injectable pen devices for diabetes and obesity medicines. Its goal is to broaden access to complex medicines while protecting North American biopharma supply chains with dependable capacity and strong regulatory support from clinical development to commercial scale.

Company size
1,001-5,000
Company stage
Growth Equity (Venture Capital)
Total funding
$3.2B
Headquarters
Blue Ash, OH
Founded
2020

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