Process Facilitator


Houston, Texas, United States of America

Job
Description

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.

Responsibilities

inter-ideograph'>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

inter-ideograph'>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.
inter-ideograph'>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

inter-ideograph'>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

Personal
Attributes

§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

inter-ideograph'>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

inter-ideograph'>Work environmentinter-ideograph'>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.


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