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Summary

ABOUT OPEXA:

Opexa Therapeutics is a publically-traded biotechnology company developing personalized immunotherapies with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases, such as Neuromyelitis Optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS.  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. 

POSITION SUMMARY:

The Process Facilitator is responsible for ancillary support of manufacturing, quality control, quality assurance, and research functions including but not limited to inventory maintenance, specimen handling, document migration, reagent formulation, and equipment maintenance. This position will serve as a liaison between departments and shifts.

DUTIES AND RESPONSIBILITIES

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

  • Serve as the key liaison between departments
  • Maintain inventory of cryopreserved cellular products including storage and documentation in Freezer Works.
  • Dynamic environmental monitoring and primary oversight of the EM program.
  • Preparation of internal process controls for daily use and distribution.
  • Migration of in-house formulations from quarantine to active inventory and maintenance of associated paperwork
  • Migration of materials and paperwork amongst departments
  • Maintenance and primary review of equipment logs for QC, Manufacturing, R & D
  • Assistance with advancing the asset management program at Opexa
  • Active participant in formalizing Opexa’s training program
  • Maintenance of the LN2 & CO2 supply
  • Maintenance of gowning stations.
  • Assist with materials management on heavy receipt days.
  • Understand and practice universal precautions and safe handling of biological materials.

Education, training and experience required

  • Bachelor of Science Degree in biological science or related field, or Associate Degree and commensurate experience.
  • Prior experience with aseptic laboratory practices and working within a cleanroom environment preferred.

General and technical qualifications

  • Must be able to work independently as well as work closely with others, and possess solid interpersonal and communication skills.
  • Knowledge and understanding of GLP, GMP, and GDP as well as FDA and EU regulatory processes.
  • Knowledge of universal precautions and handling of biological specimens.
  • Basic computer skills including word processing, spreadsheets and databases, including laboratory information management systems.

Core competencies

  • Analytical—fuses intricate or diverse information.
  • Judgment—exhibits sound judgment and makes timely decisions.
  • Planning/organizing—prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
  • Problem solving—identifies and resolves issues in a timely manner, gathers and evaluates information competently.
  • Oral communication—speaks clearly and persuasively in positive or negative circumstances, demonstrates group presentation skills and leads meetings.
  • Quality control—demonstrates accuracy and attention to detail, examines own work to ensure excellence and applies feedback to improve performance.

SUMMARY

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 and NMO as well as offers significant opportunities for career growth.  If you are eager to join the Opexa team, please send resume and salary requirements to cseeber@opexatherapeutics.com.

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



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