Managing Director, Waisman Biomanufacturing

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Limited

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Regular Job Profile:
Research Program Director (Inst)

The Waisman Center is dedicated to the advancement of knowledge about human development, developmental disabilities, and neurodegenerative diseases throughout the lifespan. One of 15 centers of its kind in the United States, the Waisman Center encompasses laboratories for biomedical and behavioral research, several scientific research cores, and a clinical biomanufacturing facility for the production of pharmaceuticals for early stage human clinical trials.

In addition to its research efforts, the Center provides an array of services to people with developmental disabilities, offers numerous educational and outreach programs to young children and their families, and trains scientists and clinicians who will serve our nation in the future. This position will work within the Waisman Biomanufacturing (WB) work unit. WB is a clinical manufacturing facility that produces biologics (gene therapeutics, cell therapeutics, recombinant proteins and vaccines) for Phase I and II Human Clinical Trials in compliance with current Good Manufacturing Practice (cGMP) guidelines.

The Managing Director will have oversight responsibility and provide strategic direction for the Waisman Biomanufacturing facility. The incumbent is expected to provide strong scientific/technical leadership toward the development of research, manufacturing and training programs; will be responsible for identifying staffing requirements and recruitment; will supervise WB manufacturing, quality assurance/quality control, pre-clinical research , and administrative personnel; will identify facility equipment needs, coordinate procurement of equipment, guide validation of equipment, and support new technological developments;

will manage and update the validation master plan as necessary; will pursue funding opportunities; will have responsibility for internal and external relations; and will have budget responsibility for the WB work unit.

• Serve on WB project teams as a subject matter expert in science quality and regulatory affairs related to supplying biopharmaceuticals for early phase clinical trials.
• Develops and audits research program budget(s).
• Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees.
• Develops, directs and evaluates research program strategic planning initiatives and establishes objectives to ensure appropriate use of financial, administrative, and staffing resources in alignment with the strategic plan.
• Develops, implements, directs, and evaluates research program operating policies and procedures to comply with regulations, institutional policies and unit objectives.
• Serves as the unit liaison and key spokesperson to internal and external stakeholder groups providing organizational information and representing the interests of the research program.

• A minimum of four (PhD) or seven (MS) years of experience in clinical biomedical manufacturing and development (preferably gene therapy, cell therapy, viral and non-viral vector research or microbial sciences).
• A minimum of two years of relevant management experience, including budgetary responsibility, client relations, and strong people and project management experience.

• Hands-on experience in a laboratory production environment that operates in compliance with current Good Manufacturing Practices (cGMPs), or related environment, with strong biologics manufacturing, assay, and process development experience.

• A Master’s Degree or PhD in Microbiology, Cell Biology, Biochemistry, Molecular Biology, Virology, Biochemical Engineering, or a related field is required.

• A Criminal Background Check will be performed.
• The successful…