CELL THERAPY PRODUCT DEVELOPMENT LEAD
CELL THERAPY PRODUCT DEVELOPMENT LEAD
The Technical Product Lead will work under the guidance of the Chief Scientific Officer (CSO)to help support GMP manufacturing by the CT2CT2 GMP Program . The Technical Product lead will work in close collaboration with several members of the Robertson Clinical and Translational Cell Therapy (CT2) Program to include the CSO, the Director of Operations, research scientists, the Process Development and Manufacturing team, regulatory management team, and the quality systems unit.
Provide technical, quality and regulatory guidance to member of the CT2 GMP Program including, process development scientists, GMP personnel, and the Quality Systems Unit.
Develop relationships with third-party vendors (CROs and CMOs) and manage external vendors as needed, communicate requests for information and materials, review technical documents. Make technical decisions under the guidance of the CSO.
Develop and implement appropriate governance structures with third-party vendors collaborating closely with CT2 Investigators, sponsors, vendor staff, and QSU.
Develop and review product specifications, COA, batch records, STM and SOP documents.
Review quality documents for clinical material release.
Work with team to develop regulatory strategies. Prepare and review regulatory documents including: INDs, clinical protocols, informed consent forms, investigator's brochures and annual reports
Draft and oversee implementation of validation and comparability studies for FDA submissions. Develop and implement strategies to streamline manufacturing,. Manage relationship with sponsors and draft documentation to support FDA submissions. Support research teams by troubleshooting any process-related issues; Track project progress and develop recommendations to address any delays.
Evaluate project technical issues and assess impact to project status. Propose, implement and monitor contingency plans to recover project status as necessary.
Provide technical and writing support for grant and contract submissions.
As needed represent the Regulatory, Quality or Technical teams during external communications and teleconference with external vendors, sponsors and management.
2524 CELL THERAPY PRODUCT DEVELOPMENT LEAD
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Ph.D. or equivalent advanced degree (MD, PharmD) in relevant biologicalsciences and/or engineering, including but not limited to molecularbiology, analytical and biochemistry, protein chemistry or biologicalengineering,or biochemical engineering.
Minimum of 5 years industry experience in the pharmaceutical and/orbiotechnology industries.1. Excellent communication, documentation and technical writing skills.2. Experience in product development including: molecular design, cellculture expansion, assay development, production optimization and cGMPmanufacture of clinical material3. Knowledge of the strategic and operational issues ofbiopharmaceutical development4. Experience in all aspects of quality, regulatory and clinicaldevelopment of biopharmaceuticals5. Demonstrated project and people management skills.
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.