The Head of Manufacturing will report to the Chief Executive Officer and will oversee the manufacturing function and groups at KaloBios.
The Head of Manufacturing will be responsible for overseeing the Manufacturing function at KaloBios. The position will manage employees, outside contract manufacturing sites, and third party vendors, and will be a member of the Senior Management Team. The position will oversee the flow of the organization?s products through development and then production, including the process development, product development, dosage form development, planning of production schedules, coordinating materials requirements, process equipment, facility, and utility validations, and recommending and implementing manufacturing policies and programs. The position is responsible for leading, identifying, and managing the activities required to manufacture the company?s clinical and commercial finished product in accordance with internal procedures and external regulations. This position will require domestic and international travel.
Identify and oversee the execution of the organization?s contract manufacturing, outsourcing and/or in-sourcing relationships and opportunities. This includes monitoring progress according to project timelines, milestones and budgets, ensuring efficiencies in the manufacturing process and accounting for and documenting these efficiencies.
Direct all pharmaceutical process and product development and manufacturing activities for all KaloBios programs.
Direct the production planning, coordination, and distribution of product supply.
Responsible for ensuring cGMP compliance for all manufacturing operations for product supply.
Direct the validation activities related to drug substance and drug product manufacturing. Oversight of the manufacturing activities at the manufacturing sites is required.
Assure appropriate facility, equipment, and utility engineering, maintenance, calibration, and validation status for all Contract Manufacturing Organizations in use by KaloBios.
The position requires close collaboration with Quality, Project Management, Regulatory and Clinical Departments.
Participate in all of CMC Quality Systems including auditing, document development and review, preparation of CMC section of IND as required.
Responsible for Pre-Approval Inspection and related activities.
Education and Experience
PhD or MS in Chemical or Biochemical science with 20+ years relevant work experience including 5 years management experience in overseeing manufacture of biopharmaceuticals.
Knowledge of and leadership experience with manufacturing of monoclonal antibodies or proteins from clinical through licensure.
Experienced in manufacturing validation and pre-approval inspections.
Knowledge and experience of cost of goods management and corresponding financial impact of business decisions
Global operations experience including import/export operations, working knowledge of regulatory, drug licensing and manufacturing operations requirements
Proven success in leading multidisciplinary project teams with excellent communication, problem-solving, and critical-thinking skills
Demonstrated experience in establishing and maintaining supplier/contractor relationships and CMO relationships
Strong working knowledge of international GMP requirements and quality systems
Proven successful leader in building positive relationships across functional lines; able to influence positive decisions and build consensus in project meetings, external associates, and with senior management
Outstanding communication and presentation skills are required. Must be able to establish peer relationships and communicate effectively with multiple company disciplines, cross-functional, and external teams
Excellent project management, organizational, computer and negotiation skills are required
Outstanding management skills and interpersonal skills, and the ability to work with all levels within the organization in a collaborative manner