Head of Site Operations

The Site Operations Head will direct all facets of Operations in a microbial manufacturing facility. He/She is accountable for achieving business objectives that ensure that work schedules are adhered to, costs are contained, and high-quality work is performed in a manner that is compliant with government regulations.

The Site Operations Head partners with the CEO & CFO to develop operational strategies and practices, to ensure compliance to Arranta’s quality standards and performance of the operations to meet goalsThe Site Operations Head will provide the leadership, management and vision necessary to ensure that the company has the proper controls, administrative and reporting procedures, and people systems in place within Manufacturing Operations. This position is responsible for meeting manufacturing compliance standards and ensuring that Arranta Bio meeting the planning and production needs of our customers, with the appropriate systems and equipment. The Site Operations Head will represent Arranta during audits and customer visits.

REPORTING RELATIONSHIPS: Oversees Manufacturing, Facilities, Engineering, Supply Chain, & EHS.

ESSENTIAL RESPONSIBILITIES

• Hire, recruit, coach, and train employees within all areas of operations.
  • Lead operations to ensure departmental commitments and deliverables are achieved to meet company objectives.
  • Oversee 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.
  • 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. Support all site audits and inspections.
  • Ensure that the plant environmental systems are properly maintained and operating to provide an environment acceptable for cGMP quality production and that the systems and equipment are tested and calibrated as scheduled.
  • Ensure adequate resources are dedicated to correcting important or critical issues via personal involvement, delegated resources, and/or appropriate escalation.
  • Lead 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 meets financial commitments within areas of direct management responsibility. Proactively identify and communicate areas for operational and financial improvement within the function and the company.
  • Maintain a high-performing organization. Hire, train, develop, and evaluate talent and effectively implements the company’s performance management practices. Establish departmental and individual expectations; provide direction and balanced performance feedback; coach, develop, and challenge direct reports; enforce company policies; and deal with personnel issues promptly.
  • Maintain open communication via one-on-one and team meetings.
  • Make decisions, based on the professional judgment, experience, budget, and the ethical guidelines of good business practices.
  • Effectively lead site managers within Operations, Supply Chain, Engineering, Facilities, and EHS in the setting of objectives and the generation of relevant measures in support of those site objectives.
  • Work closely with the Program Mgmt and Process Development teams in the generation and approval of proposals.

Required Experience:

• Bachelors/Masters degree in Biology, Biochemistry, Chemistry, or other appropriate field.
• Minimum of 12+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
• 12+ years in an Operations Leadership role.
• Disciplined individual with excellent attention to detail who is able to challenge the status quo successfully from within a team.
• Proven business acumen with bottom-line orientation.
• 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
• This role will be based in Gainesville, FL.

PHYSICAL DEMANDS

• A flexible work schedule is required.
• Ability to lift up to 25 lbs.
• 20% Travel

From: Arranta Bio