Managing Director, Waisman Biomanufacturing

This position is within the Waisman Biomanufacturing (WB) work unit at the Waisman Center. 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.

About the role

The Managing Director will have oversight responsibility and provide strategic direction for the Waisman Biomanufacturing facility. Responsibilities include:

• Providing strong scientific/technical leadership toward the development of research, manufacturing, and training programs
• Identifying staffing requirements and recruitment
• Supervising WB manufacturing, quality assurance/quality control, pre-clinical research, and administrative personnel
• Identifying facility equipment needs, coordinating procurement, guiding validation, and supporting new technological developments
• Managing and updating the validation master plan
• Pursuing funding opportunities
• Managing internal and external relations
• Overseeing the WB work unit budget

Responsibilities

• 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
• Develop and audit research program budget(s)
• Exercise 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
• Develop, direct, and evaluate research program strategic planning initiatives and establish objectives to ensure appropriate use of financial, administrative, and staffing resources in alignment with the strategic plan
• Develop, implement, direct, and evaluate research program operating policies and procedures to comply with regulations, institutional policies, and unit objectives
• Serve as the unit liaison and key spokesperson to internal and external stakeholder groups, providing organizational information and representing the interests of the research program

Requirements

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

Preferred Qualifications

• 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

Additional Information

• A Criminal Background Check will be performed
• The successful applicant will be required to complete HIPAA training and receive certification upon hire and annually thereafter

Benefits

• Generous vacation, holidays, and paid time off
• Competitive insurance and savings accounts
• Retirement benefits

Pay

$150,108 minimum; salary is negotiable and will be based on education, experience, and skills.