Asst Dir, WFIRM Manufacturing | WF Institute for Regen Medicin
Wake Forest Baptist Health
Job Title: Asst Dir, WFIRM Manufacturing
Job ID: 3314
Full/Part Time: Full-Time
Job Category: Professional / ManagementWinston-Salem, NCProfessional / Management, Medical, Healthcare7/5/2013Regenerative MedicineFull-time regular, 40 hours/weekJob Summary: The Assistant Director, WFIRM Manufacturing is responsible for the planning and timely execution of manufacturing projects associated with WFIRM''''s Clinical Manufacturing Center (CMC). The CMC is a state-of-the-art GMP and...http://www.wakehealth.edu/HR/Asst-Dir,-WFIRM-Manufacturing-3314.htm
Full-time regular, 40 hours/week
Job Summary: The Assistant Director, WFIRM Manufacturing is responsible for the planning and timely execution of manufacturing projects associated with WFIRM's Clinical Manufacturing Center (CMC). The CMC is a state-of-the-art GMP and GTP-compliant, controlled, clean room facility designed to enable the production of novel tissue engineering/regenerative medicine products. The Assistant Director will be the “upstream” customer of a technology transfer process, bringing in mature, but still experimental processes from research investigators and assisting with translating these processes into reproducible and controlled standard procedures that are compliant with relevant GMP, GTP, medical device Quality Systems regulation, pharmacopeial and institutional requirements.
Education/Experience: Master's or bachelor's degree with 10 years experience including senior management experience. PhD and/or prior manufacturing management experience within a cGPT/cGMP regulated biotech, cell processing (i.e. stem cell or bone marrow processing)/cell therapy, tissue bank or pharmaceutical company preferred.
Reports To: Director, Translational Research
Assures the technology transfer activities that involve the transition of processes for tissue processing and the manufacture of novel tissue engineered experimental therapies occur efficiently and successfully.
Serves as the Responsible Head for the tissue processing facility and assure compliance for all processing activities with 21 CFR 1271 (Good Tissue Practices).
Represent WFIRM's CMC to all regulatory organizations (ex. Food and Drug Administration) and liaison with research and scientific development staff on scientific, biological and technical issues to assure that compliance-related matters are addressed. Interact with WFIRM regulatory and quality staff to build consensus on approaches to ensure that regulatory requirements are met before proceeding and manufacturing products.
Develop departmental strategic plan and prioritize projects with an emphasis on compliance, execution, adherence to detail and continuous quality improvement.
Hires, manages and trains staff. Provides guidance and direction by establishing expectations, defining roles, supporting career development and managing performance expectations. Assures that supervisory and technical training occurs and is documented.
Responsible for assuming that manufacturing efforts yield clinical trial products that meet predetermined criteria for quality and safety are in-line with WFIRM organizational goals.
Ensures manufacturing activities are managed in accordance with available budget resources and personnel.
Approves project schedules and any deviation from schedules. Conducts root cause analysis of deviation from schedules.
Reviews and approves technical and regulatory reports, new SOPs and significant SOP revisions. Reviews vendor contracts on behalf of WFIRM and obtains ratifications from superiors. Ensures that vendors meet terms of negotiated contracts.
Maintains substantial current technical knowledge related to all procedures relevant to cell culture, cell processing, cryopreservation, aseptic processing operations, regenerative medicine product manufacturing and other relevant fields.
Skills and Qualifications:
Demonstrated ability to effectively manage others, manage performance, set and prioritize departmental goals.
Excellent time management and organizational skills.
Demonstrated ability to manage and prioritize multiple projects and meet deadlines.
Excellent written and verbal communication skills.
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