Houston, Texas

JOB SUMMARY

The cGMP Specialist I / Production is responsible for production activities in the new Translational Production & Quality cGMP manufacturing facilities at the new Ann Kimball & John W. Johnson Center for Cellular Therapeutics (KJCCT). This position is expected to lead production teams in the completion of all manufacturing processes in a safe, efficient and accurate manner. Job duties include: development of protocols and processing of human cellular products by various methods using manual and/or automated aseptic techniques; evaluating/troubleshooting problems related to product preparation and analysis; and recognizing and reporting deviations from standard operating procedures.

The cGMP Specialist I / Production is expected to work within the cGMP and cGTP guidelines, adhere to all regulatory standards, and achieve and maintain competency in routine procedures including: aseptic technique, cryopreservation, thawing, storage in liquid nitrogen, labeling and transportation of cellular products.

As a member of the Office of Translational Production & Quality, this position will actively participate in the development of manufacturing batch records for the delivery of novel products to our patients and customers, and pursue continuing education opportunities.



Requirements:

PRIMARY JOB RESPONSIBILITIES

PEOPLE - 15 %

  1. Collaborates with cross functional teams including research, process development, quality assurance and quality control. (EF)
  2. Works with research team members to assist them with transitioning their research processes to compliant cGMP SOPs. (EF)
  3. Participates in multi-functional project teams, as necessary.


SERVICE - 20 %

  1. Participates in internal audits and external inspections by Regulatory Agencies. (EF)
  2. Responds to calls/alarms off hours and weekends for facility systems and equipment failures.
  3. Demonstrates the components of the ICARE values statement.


QUALITY/SAFETY - 45 %

  1. Ensures development, pre-clinical and clinical product supply is executed effectively against changing demand schedule and meets quality requirements. (EF)
  2. Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures. (EF)
  3. Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards.
  4. Completes all hospital required and job-related in-services and applies the information as needed.


FINANCE - 5 %

  1. Works in an efficient and cost-conscious manner.


GROWTH/INNOVATION - 15 %

  1. Assists Quality Assurance Manager, cGMP Core Director and/or team members in defining release testing requirements, developing and executing protocols, performing periodic updates and/or revisions to SOPs. (EF)
  2. Interfaces with core users to assist in the translation of research processes to the cGMP manufacturing facility.


This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications:

EDUCATION REQUIREMENTS

  • BA/BS with 3 years experience or Masters with 1 year experience


EXPERIENCE REQUIREMENTS

  • 3 years experience in cGMP quality assurance or manufacturing with a BA/BS or 1 year experience in cGMP quality assurance or manufacturing with a Masters degree

CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED

  • None

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

  • Biotechnology, pharmaceutical industry experience with exposure cGMP manufacturing operations.
  • Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations.
  • Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security.
  • Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles.

SUPPLEMENTAL REQUIREMENTS


Work AttireYes/NoUniformNoScrubsNoBusiness professionalYesOther (dept approved)No

 

On-Call* Yes, on a limited basis (for Exempt jobs only)


*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.

Travel**

May require travel withinNoHouston Metropolitan area 

 

May require travel outsideNoof Houston Metropolitan area 


**Travel specifications may vary by department.


Please note any other special considerations to this job: N/A



Company Profile:

A cornerstone of Houston Methodist's strategic vision as a source for leading care, Houston Methodist Academic Institute conducts ground breaking translational and clinical research to provide the best care to patients in our community and around the world. At Houston Methodist, fostering innovations with the potential for clinical application is at the very heart of what we do. Our interdisciplinary teams of clinicians and researchers are committed to streamlining the process of translating discoveries into treatments and cures for our patients.

Houston, Texas

At Houston Methodist, Leading Medicine is more than a description of what we do; it's who we are. We take our responsibility as Houston's premier health care system seriously, and with a national reputation for excellence in patient care, innovation and research, we hold ourselves and the careers we build to a higher standard. Our culture is diverse, dynamic and challenging. We believe in our I Care Values and conduct ourselves with Integrity, Compassion, Accountability, Respect for others and a commitment to Excellence. Discover the difference for yourself and join Houston Methodist.

You can click on the video links below to learn more!

·  About Houston Methodisthttps://www.youtube.com/watch?v=ClN3mmKT0EI

·  Nursing at Houston Methodisthttps://www.youtube.com/watch?v=EUfmVeansTo

·  Houston - Best City to Live Inhttps://www.youtube.com/watch?v=MzLQzGBjHJw

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