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Resilience

Biologics and sterile injectables CDMO

Analyst 2 - Quality Control

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

About the Job

Requirements

  • Working knowledge of cGXP requirements and strong familiarity with production operations.
  • Proficient in math, laboratory, and computer skills, with an understanding of basic statistics and quality control terminology.
  • Able to take direction and correction when learning procedures and performing analysis.
  • Able to complete assigned tasks and self-assign work without immediate supervision when appropriate.
  • Able to safely handle hazardous materials.
  • Able to operate equipment in classified and non-classified areas, including a Class 100 aseptic environment and laboratory setting.
  • Able to collaborate and communicate with the team and operations groups or Quality Assurance.
  • Able to perform environmental-monitoring tasks, data review, and on-the-floor sampling in support of regulatory requirements at a sterile manufacturing site.
  • Able to work a rotating 12-hour night shift, including scheduled weekends and holidays, and provide 24/7 on-call support as needed.
  • Able to gown and adhere to aseptic behavior requirements during cleanroom activities.
  • Able 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 updates to quality-control methods and standard operating procedures.
  • Execute laboratory test protocols to support development and validation activities.
  • Review quality-control data.
  • Provide and follow up on ideas for continuous improvement in laboratory processes.
  • Perform environmental-monitoring tasks, data review, and on-the-floor sampling to support regulatory requirements of a sterile manufacturing site.
  • Work onsite in a cGMP manufacturing and laboratory environment, including cleanrooms classified up to Class 100 (ISO 5) aseptic areas.

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), 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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