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CELL THERAPY PRODUCT DEVELOPMENT LEAD

Job Title: CELL THERAPY PRODUCT DEVELOPMENT LEAD
Job Code: 2524
FLSA: E
Job Level: 73
Revised Date: 10/01/2019
Job Family: JF 05

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Occupational Summary

Lead the Product Development team to develop new cell therapy and tissue-based products and to optimize upstream and downstream manufacturing processes. The Cell Therapy Product Development Lead works under the guidance and in close collaboration with several other members including Director, the Director of Operations, the R&D laboratory, the GMP manufacturing team, the regulatory team and the quality systems unit (QSU).

Work Performed

Lead MC3 Product Development Team. Direct a team to transfer new cell and tissue-based therapies from the research laboratory stage into GMP; Plan, test and implement upstream and downstream process optimization strategies. Develop and implement characterization, identity and potency testing. Lead technology transfer efforts into department from outside collaborators. Provide scientific, technical, quality and regulatory guidance.

Prioritize and organize the flow of projects and products to be transferred into GMP. Provide consultations to investigators at early stages of product development to advise preclinical labs on manufacturing requirements for products to be used in the clinic.

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.

Develop relationships with third-party vendors and manage external vendors as needed. Communicate requests for information and materials and review technical documents. Make technical decisions under guidance. Develop and implement appropriate governance structures with third-party vendors collaborating closely with 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.

Oversee a team of 4-6 staff members to support this work. Perform all personnel actions, including interviewing, hiring, and performance management.

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.

Required Qualifications at this Level

Education/Training

Bachelor degree in relevant biological sciences and/or engineering, including but not limited to molecular biology, analytical and biochemistry, protein chemistry or biological engineering, biochemical engineering.

Experience

Six years industry experience in the pharmaceutical and/or biotechnology industries.

Skills

Excellent communication, documentation and technical writing skills.

Experience in product development including: molecular design, cell culture expansion, assay development, production optimization and cGMP manufacture of clinical material

Knowledge of the strategic and operational issues of biopharmaceutical development

Experience in all aspects of quality, regulatory and clinical development of biopharmaceuticals

Demonstrated project and people management skills


The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


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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.