Description

SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.

Raw Materials; EM; Shipping; Equipment maintenance and basic manufacturing tasks

REPRESENTATIVE RESPONSIBILITIES

???Manufacturing
Verify manufacturing/processing activities as directed following established SOPs and protocols. Complete accurate and detailed records. Complete and maintain training required to perform assigned tasks. Understand the scientific principles involved in the work being performed and apply those principles to improve techniques as appropriate.

???Operations
Lead the cleaning of the aseptic manufacturing facility and equipment. Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media. Lead routine maintenance of GMP equipment. Support equipment calibration and validation.

???Compliance
Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory. Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned.

???Process Improvement
Follow Standard Operating Procedures (SOP) and protocols. Cooperate with performance improvement initiatives and other compliance activities. Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain required proficiency and competency requirements.

???Training & Development
Train new/junior laboratory personnel in laboratory techniques and equipment operation.

Qualifications

EDUCATION/EXPERIENCE

Required:

??? High school diploma or equivalent
??? 3 - 5 years of work experience in a related job discipline
???or equivalent combination of education and experience

Preferred:

Unique Skills: