Director, Radiopharmaceutical Manufacturing Jobs

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributor of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

About the Role

The Director, Radiopharmaceutical Manufacturing is responsible for AtomVie’s cGMP routine contract manufacturing and post-development on-boarding of new programs. Reporting into the VP Operations, the Director, Radiopharmaceutical Manufacturing will be responsible for overseeing manufacturing operations, including tech transfers and validation campaigns of prescribed programs. The incumbent will provide leadership and will collaborate closely with internal and external stakeholders to meet program commitments. Working closely with other departments within the Operations team, project manager/coordinators and clients, the incumbent will drive improvements and implement changes related to the programs under their direction. This is accomplished through the direct management of production shifts managers / supervisors and their teams of production team leads, technologists, and technicians.

Location: Hamilton (On-site)

What You Will Do

• Develop the team leads and the supervisors/managers, making sure that there is a healthy and clear career horizon for all the team members, providing the tools to help in achieving their development and career progression goals.
• Represent AtomVie while interfacing clients, providing professional support in a timely manner and, whenever required, following-up with clients to ensure high service levels are maintained.
• Perform assessment of all production staff to ensure thorough understanding of radiation safety and biosafety.
• Establish training plans for production operators and monitor the progress of the new employee’s qualification process.
• Act as a role model for direct and indirect reports by maintaining transparent but professional relationships.
• Ensure in-depth GMP/GLP presence and knowledge transfer, as it pertains to specific operations and that issues are identified and dealt with through close collaborative contact with the various departments.
• Provide strategic direction, planning, tactical oversight for validation and manufacturing within the incumbent’s programs.
• Ensure that AtomVie’s production within the assigned program(s), is supported to ensure uninterrupted supply of products including but not limited to, production, technical support for investigations, training, and technology transfer.
• Formulate and recommend manufacturing policies and programs to maximize yields and reduce costs.
• Build and maintain a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites to successfully deliver on all commitments.
• Make decisions on work programs and monitor project and program costs.
• Possess knowledge and understanding of Canadian Nuclear Safety Commission (CNSC) regulations.
• Interact with the administration, regulatory affairs, product development, health physics and quality groups to meet all regulatory, financial, and operational requirements.
• Facilitate the development, planning, tech transfer, scale-up and implementation of routine operations at the approved manufacturing scale.
• Provide troubleshooting support for manufacturing issues relating to equipment and facilities.
• Represent department, including project teams, task forces, audits, and business or technical meetings with outside groups.
• Set comprehensive goals for performance and growth.
• Provide cross functional support when business demands are required.
• Work with Business Development to manage relationships with clients, partners, and stakeholders.
• Understand business issues beyond own function and implement best practices.
• Identify uses of technology to support development of business and systems best practices.
• Support Quality Assurance during GMP audits by regulatory authorities, and those relating to Contract Manufacturing/Testing activities.
• Ensure compliance with Health, Safety and Environment protection rules, with engagement of all production staff to apply the policies, procedures, and regulations applicable to their work.
• Ensure that all work performed is done in a timely and cost-effective manner according to the applicable codes and AtomVie standards including the requirement to respond to or provide direction to resolve all deficiencies during normal and after working hours.
• Implement an engagement plan for all staff to reduce attrition rates and increase satisfaction Support AtomVie’s accelerated growth in the current and, mostly, in the new facility.
• Drive improvements and operational excellence in the manufacturing facilities
• Collaborate and coordinate with the activities of the Engineering and facility support groups and outside contractors to drive the completion of tasks and projects.
• Collaborate with purchasing/procurement department to identify supply sources and options.
• Other duties as required.
• Oversee daily operations of the programs led by the incumbent including monitoring, evaluating, and driving the completion of tasks and projects.
• Interact with Quality Assurance to support OOS and deviation investigations, and associated CAPAs, allocating all needed resources to meet the organization’s quality KPIs.
• Oversee production schedules, materials, equipment, and manpower requirements.

Experience Necessary

• Degree in science/engineering and/or relevant experience in the field.
• Experience in aseptic / sterile pharmaceutical production operation is a must.
• Outstanding planning, communication, and collaboration skills
• Experience in a CMO environment will be an asset.
• In-depth knowledge of GMPs and applicable Health Canada, FDA, EMA, ICH, PDA, and ISPE guidelines.
• 5+ years’ experience at Manager or leadership level in cGMP manufacturing environment involving variable shifts (evenings/nights, weekends, etc.).
• Good understanding of Operational Excellence principles
• Excellent interpersonal, organizational, and communication skills (verbal and written)
• 5-10 years’ experience in the pharmaceutical industry; radiopharmaceutical experience is an asset.
• Must enjoy working in a fast-paced, growth-oriented environment.
• Proven track record of involvement in successful filings to Health Canada, FDA, and EMA.
• Ability to establish strong internal and external relationships.
• Strong problem-solving and troubleshooting skills.

AtomVie Offers

• Wellness Benefit
• Group Health & Dental Benefits
• Collaborative environment with experienced individuals in the field
• Opportunity for long-term growth
• Transportation allowance
• Training & Career Development
• Join a passionate team making a difference in patients’ lives
• RRSP Matching