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Quality Control Manager

CELL CULTURE COMPANY OVERVIEW:

Cell Culture Company (C3) is a contract development and manufacturing organization (CDMO) focused on custom production of recombinant protein-based therapeutic and diagnostic large molecules. We specialize in "small-scale" manufacturing of drugs for clinical trials targeting orphan drugs, personalized therapies, precision medicines, companion diagnostics, in vitro diagnostics, and more. 

C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems.

Our advantage is our ability to deliver the highest levels of quality while reducing financial risk and increasing speed to market for our customers. Our employees are experts in upstream bioreactor technology, downstream process engineering, quality control, and regulatory compliance. 

C3 has supported 20+ FDA clinical trials and serviced 1,700+ global organizations. We are currently contracted to manufacture an FDA-approved biologic at commercial scale. We are a fast-growing company with opportunities for career growth seeking employees who are passionate about contributing to the development of new and innovative therapies. 

Located in Minneapolis, Minnesota, C3 is headquartered at a 33,000-square foot facility that houses corporate offices, bioreactor manufacturing operations, a GMP-compliant custom mammalian and protein production space, and a distribution center.

GENERAL SUMMARY

We are recruiting a Quality Control (QC) Manager whose primary responsibility will be to provide QC oversight of manufacturing of drug product and stage appropriate validation of bio analytical methods for cell products.  The QC Manager will also be responsible for environmental monitoring, raw material testing, in-process and final product testing as well as for the purchase, installation and qualification of QC instrumentation.

Ideal candidates will be detail-oriented quality professionals with an understanding of the manufacture of biologics, specifically in the areas of monoclonal antibody and recombinant protein production.  This position will work directly with the bioservices and supply chain/purchasing teams to complete a variety of initiatives aimed at ensuring product quality and customer satisfaction.

DUTIES & RESPONSIBILITIES

  • Manage the transfer and validation of analytical methods to QC and/or to a contract-testing lab.
  • Establish specifications and testing processes for raw materials.  Develop in-process and final specification system(s) for drug substance and drug product.
  • Establish user requirements for purchase and qualification of QC analytical equipment.  Work with internal and external resources to maintain equipment in an optimal state.
  • Complete routine batch record review, including test data and related documents for environmental and in-process testing, and drug substance and drug product release. Generate CoAs for product release.
  • Communicate with agents from regulatory agencies and participate in Pre-Approval Inspections.  Assist in the preparation of required supporting documentation for such interactions.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.  Develop, revise and review related SOPs, qualification/validation protocols and reports.  
  • Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to environmental monitoring and analytical procedures, and provide updates at meetings.
  • Monitor the GMP systems and trend data to ensure compliance with documented policies.  Gather metric information for use in continuous improvement activities for areas of responsibility.
  • Perform other duties as assigned by immediate supervisor.

QUALIFICATIONS/REQUIREMENTS

  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/820, clinical trials, ISO 9001, and ICH Q10).
  • Knowledge of analytical techniques such as HPLC, ELISA, PCR, FACS, SDS-PAGE, IEF, UV absorbance, and other methods applicable to the testing of biopharmaceuticals.
  • Working knowledge of the application of microbiological techniques such as air monitoring, water testing, surface monitoring, and genus and species identification of various microbes.
  • Proficiency in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills, including the ability to communicate and work independently with scientific/technical  and regulatory personnel.
  • Ability to multi-task, remain organized, and possess the sense of urgency needed to meet goals, objectives and deadlines.
  • Ability to take direction, complete assigned tasks and work independently.

WORKING CONDITIONS

  • Office conditions with standard office equipment: computer, copier, fax and phone.
  • Occasional lab/clean room work requiring gowning in booties, union suit, face mask, hood and gloves.
  • Ability to sit and stand for long periods of time, and to use computer systems requiring frequent, long-duration mental and visual attention. 
  • Lifting requirements of up to 40 pounds occasionally.
  • Weekend work and non-standard work hours and travel occasionally required due to project demands.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

Please visit our website to learn more about our company:  https://cellculturecompany.com.

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