View Our Website View All Jobs

Quality Control Manager


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.


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.


  • 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.


  • 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.


  • 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:

Read More

Apply for this position

Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity / Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status

Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 1/31/2020
Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities.i To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability. Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

If you already work for us, your answer will not be used against you in any way. Because a person may become disabled at any time, we are required to ask all of our employees to update their information every five years. You may voluntarily self-identify as having a disability on this form without fear of any punishment because you did not identify as having a disability earlier.

How do I know if I have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Cancer
  • Diabetes
  • Epilepsy
  • Autism
  • Cerebral palsy
  • Schizophrenia
  • Muscular dystrophy
  • Bipolar disorder
  • Major depression
  • Multiple sclerosis (MS)
  • Missing limbs or partially missing limbs
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Impairments requiring the use of a wheelchair
  • Intellectual disability (previously called mental retardation)
Please check one of the boxes below:

You must enter your name and date
Your Name Today's Date
Reasonable Accommodation Notice

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

iSection 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.