JOB SUMMARY

The Supervisor – Continuous Manufacturing will supervise facets of manufacturing in the continuous manufacturing lab facility. This role is responsible for achieving business objectives that ensure that work schedules are adhered to, costs are contained, and high-quality work is performed. This person is ideally a person with operations experience in RNA and biologic therapeutics.

The Supervisor – Continuous Manufacturing will provide the leadership, management, and vision necessary to ensure that the continuous manufacturing lab has the proper controls and people systems in place within the Manufacturing function. This position is responsible for meeting manufacturing standards and ensuring that the continuous manufacturing lab team is meeting the planning and production needs of the Continuous Manufacturing FDA Grant project.

ESSENTIAL JOB FUNCTIONS

• Start-up, development, and maintenance of the Continuous Manufacturing lab.
• Supervise day-to-day Continuous Manufacturing lab operations, including but not limited to manufacturing, and collaborate with manufacturing support functions (e.g., Facilities, Procurement, Materials Management, QC), to ensure departmental commitments and deliverables are achieved to meet company and project objectives.
• Supervise the planning, scheduling, and production functions to ensure that adequate materials, equipment, and personnel are available to meet production schedule.
• Interface with clients and regulatory individuals when necessary.
• Encourage and enforce a culture of compliance regarding Safety, Environmental, Quality standards as required by cGMPs, Health Authority’ regulations, government agencies, and company standards / policies.
• Ensure adequate resources are dedicated to correcting important or critical issues via personnel involvement, delegated resources, and/or appropriate escalation. This often involves collaborative interaction with other departments.
• Support departmental and site teams to solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
• Provide high-quality forecasts and consistently meet financial commitments within areas of direct management responsibility. Proactively identify and communicate areas for operational and financial improvement within the function and the company. 
• Collaboration & goal setting with all other organizations at the site including PD, QA, QC, etc.
• Maintain open communication via one-on-one and team meetings.
• Make decisions, based on professional judgment, experience, budget, and the ethical guidelines of good business practices.
• Work collaboratively with site managers within Operations, Supply Chain, Engineering, Facilities, Quality, and Process Development in the setting of objectives and the generation of relevant measures in support of those site objectives.
• This person may be asked to work and support the Boxborough GMP Manufacturing team in the future as needed.
• Other responsibilities may be added as required.

• Bachelors/Master's degree in biology, Biochemistry, Chemistry, or other appropriate field.
• Minimum of 4 years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
• Disciplined individual with excellent attention to detail who can challenge the status quo successfully from within a team.
• Manufacturing Information Systems know-how and experience in a high growth setting.
• Ability to work by influencing peers and their reports and gain their cooperation.
• Ability to see the “big picture” while being capable of driving detailed, tactical execution. A high sense of urgency and a commitment to delivering results is essential.
• Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
• Strong interpersonal and communication skills, verbal and written
• Proven Management and Leadership skills.