VP Operations

About the role

The Vice President of Operations will report to the Chief Operations Officer, North America, and is accountable for the overall North America manufacturing operations with a primary focus on safety, reliability, manufacturing performance, and process engineering. Accountabilities include site management, compliance with all regulations, production activities, process and asset reliability systems, manufacturing and process engineering, technical services management, facility management, and personnel management of all site employees. Partnering cross-functionally with other site functional leaders who report to off-site executives is paramount for success.

Responsibilities

• Ensure the site is compliant with all regulatory requirements including Quality-related issues, Health, Safety & Environmental, Radiation Safety Programs, Hazardous Material Handling & Disposal and Facilities code.
• Champion a strong safety culture and ensure internal audits are performed to continuously monitor Compliance with all aspects of Site Operations against ever-changing regulations.
• Develop specific improvement plans and budgets moving the site from a state of compliance to a state of Regulatory Excellence.
• Develop and implement Reliability systems for all process, manufacturing, and facility equipment.
• Leverage process engineering and continuous improvement disciplines to identify issues and track resolution of the most critical, resulting in higher on-stream times, improved manufacturing throughput, and lower costs.
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Manage site expense expenditures to drive the site financial performance and exceed the established financial target.
• Perform strategic maintenance and growth planning and manage the resulting Capital projects.
• Demonstrate project management experience with effective cost controls, risk mitigation techniques and scheduling accomplishments.

Requirements

• Bachelor of Science degree required. Master of Science degree is preferred.
• 18+ years or more of relevant experience in managing operations is required.
• 10 or more years in a leadership role required.
• 5 or more years minimum of manufacturing experience in the pharmaceutical industry.
• Demonstrated experience in process engineering, including process design, optimization, scale-up, validation, and troubleshooting in a regulated manufacturing environment.
• Proven track record implementing asset and process reliability programs (e.g., preventive/predictive maintenance, root cause analysis, RCM) to maximize on-stream time and equipment availability.
• Proven leadership experience supporting and empowering employees to build a culture that demonstrates the Curium values of Integrity, Commitment, and Collaboration.
• Experience with managing radiopharmaceutical operations, cyclotron operations or PET networks is desired.
• Experience driving Compliance with all local, state, national and international regulatory bodies (e.g. FDA, DEA, HC, EU, TGA, NRC, OSHA, EPA) through continuous improvement plans.
• Demonstrated commitment to Safety management to protect all employees, contractors, visitors and the community.
• Demonstrated experience leading manufacturing operations and process engineering to deliver safe, reliable, and high-throughput production.
• Experience managing utility and facility support infrastructure reliability programs.
• Exceptional written and verbal communication skills with the ability to compile concise and convincing documents and deliver presentations to multiple levels of the organization.
• Ability to read and interpret various engineering documents (schematics, wiring diagrams, piping diagrams, blueprints, etc.) with an understanding of electrical, plumbing, and HVAC systems is a plus.
• Demonstrated experience negotiating contract terms and conditions.
• Proficiency with computers and software, with a desire to learn new software applications to help drive improvement.
• Working knowledge of CMMS and ERP systems.
• Ability to articulate examples of Innovation during your career that have improved your company or business.

Working Conditions

• Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching.
• Must be able to physically negotiate stairs and evacuation ladders with or without accommodation.
• Wear and operate safety equipment, enter vessels, and inspect equipment.
• Use of proper lifting and movement techniques is necessary to prevent injury; material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible.
• Willingness to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
• Willingness to travel up to 30% as required by business needs.