Executive Director/ Senior Director Cell and Gene Therapy Analytical Services

This role is the senior most individual for this division situated at the corporate headquarters as the largest of the Bioanalytical sites. The ideal candidate will be a client facing senior analytical scientist with the business acumen to lead and build the departments across multiple sites while managing a P&L.  This position provides senior scientific and operational leadership for a division that provides analytical support for gene and cell therapy products through every stage of development. Included are potency assays that are on the critical path and offering de novo development, optimization, qualification, validation and GMP compliant final product and product release testing services for both allogenic and autologous therapies.   The Senior Director is ultimately responsible for:

·       Study Conduct for bioanalysis projects

·       Resource allocation

·       Client interaction to handle issues and/or drive business development efforts for client acquisition

·       Subject Matter Expertise for potential regulatory audits under both GLP and GMP guidance.

The ideal candidate will be a great scientist who can talk with the clients to solve complex issues and be the ultimate point of contact with all projects both internally and with external regulatory agencies. This challenging role offers the ability to reshape the capabilities of a company and help steer its trajectory.

It is important that this individual has GMP experience in batch release testing.  One of the management goals for this role will be to foster the evolution of GLP scientists who have had the ability for flexibility in judgment calls into a GMP environment which is much more of a rigid structure.

 

Requirements:

·       Ph.D. in Cell or Molecular Biology or Protein Chemistry. 

·       10-15 years experience in the Biopharmaceutical Research and Development space with a portion of that time in a contract research setting.

·       Experience leading managers and team leaders in a contract research space or in a contract development manufacturing organization. 

·       Dynamic personality and excellent communication skills in both verbal and written communications – Specific experience discussing projects with Clients, Internal or External.

·       Demonstrated ability to run simultaneous projects across multiple sites.

·       Demonstrated experience in building teams and increasing performance of those teams.

·       P&L/ Budgeting responsibility for a department or group. 

·       Experience developing and validating LC-MS/MS methods in support of clinical and non-clinical studies.

·       Experience in developing LC methods for HPLC and UPLC systems

·       Experience in both a GLP and GMP regulatory background with familiarity of audits. –

·       Experienced in the operational and business execution and growth activities of contract research

 

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