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
Regular/Temporary: Regular
Job Category: Professional / Management
Winston-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...

Job Description


Regenerative Medicine

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

Essential Functions:

1.

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.

2.

Serves as the Responsible Head for the tissue processing facility and assure compliance for all processing activities with 21 CFR 1271 (Good Tissue Practices).

3.

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.

4.

Develop departmental strategic plan and prioritize projects with an emphasis on compliance, execution, adherence to detail and continuous quality improvement.

5.

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.

6.

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.

7.

Ensures manufacturing activities are managed in accordance with available budget resources and personnel.

8.

Approves project schedules and any deviation from schedules. Conducts root cause analysis of deviation from schedules.

9.

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.

10.

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.

To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".

Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-0175. Office hours are Monday-Friday, 8:00am-5:00pm.

If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at accommodationrequest@wakehealth.edu.

It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.



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