Capital Associated Industries, Inc.
  • Durham, NC, USA
  • Full Time

CoImmune Inc. is a US company based in Durham North Carolina that was founded in 2019 based on its expertise in the development and manufacture of cell-based therapeutics to treat unmet medical needs including cancer, autoimmune and inflammatory diseases. CoImmune has a 20,000 sq. ft. cGMP manufacturing facility capable of supporting clinical studies from Phase I through Phase 3. The company is preparing to initiate its first Phase 2 clinical trial using a strategic combination of immune-oncology therapeutics. In addition to developing its own therapeutic pipeline, the company plans to use its excess cGMP manufacturing capacity to provide revenue-generating contract services for the manufacturing of third-party clinical stage cell-based products.    

 

The Quality Control Manager will be responsible for management of the Quality Control group and oversee the development, implementation and maintenance of quality control systems to ensure compliance with GMP regulatory requirements for cell-based therapies. The Manager will also establish objectives for the group and work with senior management on managing the QC activities.

 

RESPONSIBILITIES: 

  • Work as an effective team member cross-functionally to achieve company objectives for initiation and support of clinical trials
  • Direct the development, implementation, or tech transfer of all methods for testing and release of in process, and release testing for biological products and reference materials.
  • Directs timely interpretation of testing results and trending of data to ensure conformity with quality specifications, including review of assay performance; and works with R&D as needed to ensure methods and results are as expected.
  • Direct all QC assay validations including working with R&D to establish critical and optimized methods, followed by method validation protocol development, execution and generation of final reports ready for submission to regulatory authorities
  • Develop and manage the departmental budget and setting of short- and long-term department goals
  • Manage initiatives to improve QC processes, cost effectiveness, enhancing efficiencies, safety and compliance of processes and procedures within current regulatory standards. Trend test data and review assay performance.
  • Ensures testing is in accordance with SOPs and regulatory requirements
  • Directs timely preparation of testing protocols and reports that are scientifically supported and in compliance with regulatory requirements.
  • Provides oversight for GMP activities including document management of QC procedures, review of investigations, deviations, change control, and environmental monitoring program.
  • Ensure department training compliance in all aspects of testing, cGMPs, SOPs, company policies and safety policies.
  • Selects, develops and evaluates QC personnel; directs QC organizational development, managing resources, mentoring, coaching and counseling and managing performance and compensation processes for the department. 
  • Represent the QC laboratory during audits conducted by internal QA personnel and regulatory agency representatives to provide information and handle questions and/or concerns.
  • Other duties as required.

 

QUALIFICATIONS: 

  • S. Degree or PhD (preferred) in a scientific discipline, preferably biology or chemistry, and 10 years relevant biologics industry experience in a cGMP environment.
  • Experience overseeing the quality control and assay validation function at a biologics GMP manufacturing facility is required.  Commercial product experience in Quality Control is desirable.
  • Experience in the development of cellular vaccines desired, including experience in flow cytometry cell counting, and RNA gel electropheresis.
  • In-depth knowledge of all quality control functions and responsibilities, lot release record responsibility, investigations, and FDA manufacturing requirements;
  • Demonstrated ability to manage, motivate and mentor scientific personnel and encourage teamwork among functional groups in Operations and R&D.
  • Strong verbal and written communication skills are essential.
  • Excellent scientific analysis and interpretation skills as well as problem solving skills.
  • Ability and willingness to be regularly, predictable and reliably at work 
Capital Associated Industries, Inc.
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