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About Opexa

Opexa prides itself on having achieved a culture of scientific excellence, entrepreneurial pursuit and dedication to improve the life of those suffering from serious medical disorders.  Each member of our team is committed to our goal of bringing novel therapies to market.  Our lead product, TcelnaTM, is an autologous T-cell immunotherapy being developed for the treatment of Multiple Sclerosis (MS), a chronic T-cell mediated demyelinating disease of the brain and spinal cord. TcelnaTM is specifically tailored to each patient's unique T-cell immune response profile to myelin.  As such, TcelnaTM is poised to be the first-ever, patient-specific therapy for MS.

General Purpose

The Cell Therapy Manufacturing Manager reports to the Senior Director of Manufacturing and provides confidence, stability, leadership, and guidance to the manufacturing group, particularly when unscheduled or unplanned events occur, and is ultimately accountable for the completion of project and product manufacturing goals.

Duties and responsibilities

Primary duties and responsibilities of this role include the following. Other related duties may be assigned to meet business needs.

  • Supervise Manufacturing personnel including scheduling of tasks and project-related work as well as overseeing execution of procedures.
  • Coordinate routine manufacturing activities with other operational functions including R&D, Quality Systems, QC, Facilities and Materials Management.
  • Maintain projections of materials/supplies and process intermediate inventories required to meet product manufacturing demands.
  • Monitor process performance, product quality and Manufacturing facility trends.
  • Collaborate with Facilities and Validation staff to maintain the GMP facility and critical equipment in an operational and compliant state.
  • Review and sign-off on all batch records as complete, correct and in compliance with approved Manufacturing and Quality Systems standards and GMPs.
  • Identify, address and document manufacturing deviations including leading investigations, driving the deviation process to timely closure, and implementing corrective actions as appropriate.
  • Work closely with Quality Systems to maintain and continuously improve quality aspects of the manufacturing operation.
  • Provide substantive input into critical manufacturing-related decisions.
  • Author and/or approve Manufacturing documents.
  • Manage the training of staff and their continued strict adherence to standard processing practices.
  • Foster teamwork and comradery across the Manufacturing group as well as an attitude of cross-functional cooperation.

General and technical requirements

  • Skilled in cell culture and aseptic processing; experienced with closed culture systems and standard blood banking and/or cell processing equipment and techniques; knowledgeable of critical process parameters associated with cell culturing, harvesting and cryopreservation processes.
  • Strong working knowledge of policies and procedures associated with GMP manufacturing of clinical trial materials.
  • Prior supervisory experience and ability to train others and serve in an advisory capacity to Manufacturing staff.
  • General understanding of laboratory safety rules and universal precautions; radiation safety knowledge is a plus.
  • General computer skills, including the use of Excel spreadsheets and data trending programs.
  • In-depth understanding of cell therapy manufacturing in particular autologous cell therapies derived from whole blood and/or aphaeresis product is preferred.
  • Understanding of scale-out strategies and experience with high-throughput autologous manufacturing operations is highly desirable.
  • Familiarity with T-cell culturing and processing is preferred.
  • Understanding of technology transfer including transitioning of research techniques into GMP production methods and start-up of existing or new processes at internal and external manufacturing facilities is a plus.

Education, training and experience

  • BS in biological science, clinical laboratory sciences, or medical technology.
  • Minimum of 9 years relevant, hands-on laboratory experience including cell culturing and processing.
  • At least 6 years prior experience in GMP manufacturing of clinical or commercial products.
  • At least 3 years of prior supervisory experience.
  • Experience in autologous biologics/cell therapy manufacturing or high-throughput manufacturing is highly desirable.


Opexa is a fast-paced, dynamic, and exciting place to work.  Working at Opexa provides individuals the opportunity to truly make a positive impact on the lives of those suffering from MS as well as offers significant opportunities for career growth.  If you are eager to join the Opexa team, please contact email your resume and salary requirements to Cathy Seeber, HR Manager, at

Benefits include health, dental, vision, life, disability, 401k, FSA, HSA.  EOE M/V/F/D

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