In-Process Testing Associate II - CAR T Cell Therapies

Location
Duarte, California
Salary
Competitive
Posted
February 21 2021
Ref
10009795
Position Type
Full Time
Organization Type
Healthcare/Hospital
Position Summary:
The Cellular Immunotherapy GMP Manufacturing Department is looking for a talented Cell Manufacturing in-process testing Associate II (CMTA II)for supporting in-process testing in manufacturing process and analytical development for cellular immunotherapy products. This is a fast-paced lab involved in cutting edge technology, research and clinical cellular immunotherapeutic programs. Testing may include but not limited to the following viability (automated and manual cell counts), Flow Cytometry Assays, ELISA, RT-PCR, and cytotoxicity assays.The CMTA II will also be trained in manufacturing process and project specific techniques and procedures to support manufacturing activities.
Key Responsibilities include:
  • Application of aseptic techniques.
  • Perform the procedures/methods and testing for manufacturing productsfollowing established SOPs in cGMP facility and non-GMP laboratory under limited supervision.
  • Assists in training all personnel in manufacturing team: Develops and updates training plans.
  • Maintain accurate inventory of analytical supplies and provide routine lab support and maintenance activities.
  • Develop process control plans including new equipment qualification and process change control plans.
  • Data entry of all patient/product information and testing into a computer database and generate reports.
  • Assist in developing and adapting analytical methodology and new manufacturing procedures.
  • Assist in creating, reviewing and revising Standard Operating Procedures as necessary for in-process testing, cell product manufacturing, process development and analytical development.
  • Perform equipment quality control, preventive maintenance, and troubleshooting for analytical and lab instruments.
  • Meticulous attention to detail and accuracy in lab work and documentation, strictly following established SOPS, as well as accurate record keeping and lab documentation.
  • Cooperate with Quality Control (QC) and Quality Assurance (QA) groups to ensure cGMP compliance.
  • Required to wear pager, or other communication devices, to respond promptly to emergency calls and for critical equipment failure.
  • Complete and maintain all training required by City of Hope.
  • Cooperate with other performance improvement and compliance activities within the department and in the institution.
  • Maintains current knowledge of manufacturing/analytical techniques and industry practices.
  • Follow established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
  • Practice a high level of integrity and honesty in maintaining confidentiality.

Basic education, experience and skills required for consideration:
  • Master's degree in biological science or related field, with at least 1 year of post-degree research experience or Bachelor's degree in biological science or related field, with at least 2 years of post-degree research experience.
  • 6 months or more of hands-on mammalian cell culture and analytical experience.
  • 6 months or more of cGMP experience.
  • Biotechnology or pharmaceutical industry experience.

Required Aptitude:
  • Good written and oral communication skills, team player, self-motivated, excellent personal hygiene.
  • Practice good judgment in all professional activities.
  • Ability to analyze data and compose reports.
  • Ability to develop and update policies and procedures.
  • Ability to set and model professional work standards.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
  • Posting Date: Apr 21, 2021
  • Job Field: Research
  • Employee Status: Regular
  • Shift: Day Job

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