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 Quality Validation Specialist will report to the Chief Development Officer and will work with all senior management and directors to develop qualification/validation strategies and design the necessary studies to provide documented evidence that all equipment, assay methods, processes and functional systems have been qualified/validated. The Quality Validation Specialist, with assistance from other Opexa staff, will conduct and process qualification programs as well as write the protocols and reports. The Quality Validation Specialist will provide validation support for facility expansion, compliance with regulations and upgrades.

Job Responsibilities:

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

• Maintain up-to-date knowledge of cGMP regulatory issues particularly pertaining to validation activities and ensure that company validation policies and procedures are current and relevant to a biotech/ aseptic manufacturing environment.
• Generate protocols, sampling plans and acceptance criteria, and qualification/ validation documents and reports.
• Execute qualification/ validation activities collect and analyze qualification data and prepare final reports for approval by management.
• Manage resources and validation timelines.
• Coordinate and assist in commissioning and qualification activities by outside vendors and/or contractors.
• Participate in audits and follow up on corrective actions relating to validation activities.
• Work with departmental management to establish and monitor quality parameters.
• Support method development activities and review method develop documents.

Education, training and experience:

• BS in a laboratory science - MT (ASCP) or equivalent.
• 3-5 years of laboratory experience in validation and quality control activities.
• Familiarity with a variety of the field's concepts, practices, and regulations.
• Knowledge of universal precautions and handling of biological specimens.
• Practical knowledge of laboratory instrumentation and basic troubleshooting techniques.
• Practical knowledge of general laboratory techniques (i.e. pipetting, balance use, wet chemistry).
• General computer skills, including proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project and Visio.
• Problem solving—identifies and resolves issues in a timely manner, gathers and evaluates information competently.
• Highly professional demeanor and the ability to effectively communicate with individuals at various organizational levels.
• Exceptional technical writing, review and analytical skills.
• Oral communication—speaks clearly and persuasively in positive or negative circumstances, demonstrates group presentation skills and leads meetings.
• Highly reliable with a well-defined sense of tact and integrity.
• Confident self-starter with the ability to exercise sound independent judgment and proactively meet the demands of the business.
• Energetic with a positive attitude, able to effectively multi-task and prioritize work in a fast-paced environment.
• Quality control—demonstrates accuracy and attention to detail, examines own work to ensure excellence and applies feedback to improve performance.
• Ability to work independently as well as work within a team environment.

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