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Associate Director, Process DevelopmentPosted by: WuXi AppTec Inc.
Posted date: Dec-26-2017
Location: Philadelphia, PA
Direct process development activities and act as key technical representative working with clients to define PD programs leading to GMP tech transfers. Will be required to interact with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, and Materials Management groups. As needed, further interaction will be required with material/equipment vendors and commercial partners.
Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues.
Create process development programs for manufacturing of gene therapy products (viral-vectors).
Interact with clients to support client programs, and promote services.
Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems.
Participate in employee performance appraisals in a timely and objective manner.
Develops budget projections, material and staffing forecasts.
Establish and ensures adherence to data recording procedures to meet quality standards suitable for support of late clinical phase and commercial filings.
Demonstrates managerial skills and a strong working knowledge of the regulatory compliance requirements for the production of biologicals for clinical and commercial use.
Demonstrates a clear understanding of the contract manufacturing business and effectively manages PD operations to address customer and business needs in a timely manner.
Participates in hiring, training, supervising and evaluating staff.
Manage a PD lab related to gene therapies
Work closely with tech transfer team to troubleshoot any processes that have been transferred to Manufacturing.
Serve as subject matter expert for routine manufacturing of viral vectors.
Bachelor’s Degree in Bioprocess Engineering, or related field is required; advanced degree (Masters of PhD) is preferred.
7-10 years of experience working with suspension cell culture systems is preferred, minimum of 5 years is required.
Experience producing viral vectors or relevant material in mammalian single use bioreactor based processes in strongly preferred.
Experience in a pilot plant environment is preferred.
Experience in a CMO, or tool provider is preferred.
Thorough understanding of raw material requirements for GMP processing is required.
Experience directing a large scale (>250L) bioreactor core facility in tech transfer is required, experience with 2000L single use bioreactors is strongly preferred.
Background in cell therapy with experience with hyperstacks and micro carrier technology is preferred.
Experience with autologous and allogenic process design is preferred.