Job Title: Process Facilitator
Responsible to: Director of Process Development & Manufacturing
Role: The Process Facilitator reports to the Director of Manufacturing and Process Development. The Process Facilitator is responsible for managing centralized functions of the laboratories at Cell Medica – Houston which is inclusive of but not limited to centralized accessioning and primary specimen processing, maintenance of raw material and consumable inventory and the biorepository. To support the Company's vision, mission, and values by demonstrating: excellence and competence, collaboration, innovation, respect, commitment to our community, and accountability.
- Primary duties and responsibilities of this role include the following. Other related duties may be assigned to meet business needs.
- Supports internal teams (manufacturing, process development, quality control, quality assurance and R&D) with performance of common/cross-functional task
- Functions including but not limited to inventory maintenance, specimen accessioning and primary processing, document management & migration, data management, reagent formulation and tracking of equipment maintenance
- Perform basic laboratory functions and common laboratory assays/processes
- Management of cryopreserved cellular products and other critical raw materials assuring proper storage and documentation
- Preparation of internal process controls for daily use and distribution
- Perform irradiation of biological samples when & where appropriate
- Facilitate preparation and migration of in-house formulations from quarantine to active inventory and maintenance of associated paperwork
- Understand and practice universal precautions and safe handling of biological materials
Education and Experience
The following are the minimum qualifications and competencies that an individual would need to successfully perform the duties and responsibilities of this position. The individual may be required to demonstrate proficiency in some of these depending on the department and/ or job functions assigned.
General and technical
- 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
Education, training and experience
- Bachelor of Science Degree in biological science or related field, or Associate Degree and commensurate experience
- 2 years + Prior experience with (aseptic) laboratory practices and/or working within a cleanroom environment desired
- 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
- Be able to communicate fluently both written and verbally in English
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-able individuals to perform the essential functions of the job.
- Manual dexterity required for occasional reaching and lifting of small objects, operating laboratory equipment, and handling small specimens
- Will be required to perform light lifting, climbing and stooping for stocking inventory carts
- May be required to work alternate shifts and on-call rotations
- Must be able to work in tight spaces, around laboratories, manufacturing and equipment areas, and in noisy environments
- May be required to gown aseptically
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-able individuals to perform the essential functions of the job within the environment.
- The office is clean, orderly, properly lighted and ventilated. Noise levels are considered low to moderate.
- Exposure to blood or other potentially infectious materials. Due to the risk of acquiring hepatitis B virus (HBV) infection, the Company requires employees in this position to provide documentation that their Hepatitis B vaccination series is complete or underway. Otherwise such vaccination must be scheduled to begin within 10 days of employment, at the expense of the employer.
- The primary work area houses a sealed-source radioactive instrument. While the Company conducts quarterly radioactive testing and corrective procedures, if necessary, to assess potential radioactive release, there is a potential of minor exposure to radiological hazards.