Asst Dir, WFIRM Process Dev | WF Institute for Regen Medicin
Job Title: Asst Dir, WFIRM Process Dev
Job ID: 3315
Full/Part Time: Full-Time
Job Category: Professional / Management
Full-time regular, 40 hours/week
Process Development Assistant Director is responsible for day-to-day process developmental activities. Oversees and conducts project related activities for process development of clinical materials. Performs a variety of moderately complex and generally standardized physical, chemical, or biological operations using equipment and procedures. Provides direction and guidance to lower level personnel.
Oral and/or written instructions received from management.
Education/Experience: PhD and prior management experience within a research facility, cell processing (i.e. stem cell or bone marrow processing)/cell therapy, tissue bank or pharmaceutical company preferred. Master's or bachelor's degree with 10 years experience including senior management experience.
Reports To: Director Translational Research
In charge of day-to-day process developmental activities.
Oversees and/or executes process development to transfer technology to manufacturing for multiple Phase I and Phase II clinical trials in the GMP facility.
Develops, implements, executes and follows developmental processes related to project defined work.
Supervises, develops, implements and/or follows standardized production processes once developed in PD including cell isolation and expansion, and biomaterials manufacture.
Writes, revises and/or executes batch records and follows SOPs in support of projects/processes that will move into the GMP facility.
Attends internal and external seminars, training sessions and workshops to maintain competency in job functional requirements.
Oversees the operation and/or operates a variety of equipment including but not limited to centrifuges, microscopes, biosafety cabinets, incubators and liquid nitrogen freezers.
Oversees training and/or trains lower level personnel on all equipment functions and processing/cell culture techniques.
Takes initiative to identify opportunities for process improvement and implementation.
Skills and Qualifications:
Excellent recordkeeping and documentation skills.
Strong communication skills, both verbal and written.
Understanding of Microsoft Excel, Word and other computer software.
Outstanding interpersonal skills, high energy and motivated.
Supervisory experience required.
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