Manufacturing Process Manager

AtomVie Global Radiopharma Inc.; Hamilton; On-site; CAD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Process Manager to lead the operations of multiple production lines. This role involves ensuring the consistent production of high-quality radiopharmaceuticals while adhering to strict GMP guidelines. You will coordinate production planning, manage staff training, and oversee equipment maintenance. Join a forward-thinking organization that values collaboration and innovation, and play a vital role in transforming healthcare through advanced manufacturing processes. If you are passionate about making a difference in patients' lives, this opportunity is for you.

Benefits

Group Health & Dental Benefits

RRSP Matching Program

Perkopolis

Employee Assistance Programs

Wellness Programs

Parking Allowance

Qualifications

• 5-10 years experience in pharma/biotech manufacturing.
• Minimum of 2 years in a leadership role in GMP environment.

Responsibilities

• Coordinate day-to-day operations of production lines.
• Ensure compliance with GMP, quality, and safety standards.

Skills

Capacity Planning

Scheduling

Problem Solving

Communication

Collaboration

GMP Knowledge

Education

Diploma/Degree in Chemistry

Diploma/Degree in Biology

Tools

ERP Systems

Job description

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

About the Role

The Manufacturing Process Manager will coordinate the day-to-day operations of multiple production lines/shifts for programs. As Manufacturing Process Manager, you will assign tasks and adjust workloads to meet production schedules and plans, monitor training, assess the progress of the employees and oversee manufacturing quality and safety.

Reporting to the Director, Radiopharmaceutical Manufacturing, The Manufacturing Process Manager will also be responsible for overseeing the manufacturing operations efficiency through improvement projects implementation in collaboration with the Continuous Improvement manager, coordinating production plans with various departments in order to make sure that materials and other resources are in place to support production plan, and continuously monitoring and reporting results out of the shop floor.

What You Will Do

• Ensure consistent production of radiopharmaceuticals according to operational, quality, and safety requirements.
• Lead on production planning activities to include production scheduling, materials planning, and reporting.
• Act as point of contact for other departments and team members to coordinate matters related to manufacturing.
• Serve as leader for manufacturing related items, troubleshooting, and validations.
• Ensures that adequate staffing levels are maintained. Monitors overall training progress and reports the information to the Director of Radiopharmaceutical Manufacturing.
• Oversee and coordinate equipment calibration, maintenance and follows up on associated documentation.
• Systematically identifies facilities, equipment, utilities and processes that require improvements and ensures these improvements and/or investments are budgeted and effectively implemented.
• Maintains, edits and reviews manufacturing related standard operating procedures (SOP’s) and Master batch records (MBR’s). leading non-conformance investigations.
• Ensures that production department is in inspection ready state (GMP, Quality, Safety, HP) and participates in customer and regulatory or agency audits as required.
• Projects a professional and supportive demeanor while promoting safe and positive working environment.
• Support Business Development and Product Development teams regarding clients’ relationship when manufacturing inputs are of importance.
• Monitor and report production results against KPIs and efficiency metrics.
• Work alongside own supervisor to develop action plans for any decision-making on batch release and to troubleshoot and problem solve critical issues related to production.
• Inform Quality group of any production problems as well as any concerns with drug product quality immediately.
• Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable regulatory requirements relating to nuclear safety and cGMP manufacturing.
• Adhere to the Health Canada GMP requirements for sterile pharmaceuticals.
• Complete all other duties as required.

What You Bring to the Role

• You have experience in capacity planning and scheduling.
• Demonstrated success in managing and developing people in a GMP manufacturing environment.
• Ability to establish internal and external networks.
• You have excelled problem solving skills.
• Excellent planning, organizing, communication, and collaboration skills
• Knowledge of materials management systems or ERP systems applications is a plus.
• You thrive in a fast-paced setting.

Requirements

• Diploma/degree in Chemistry, Biology or related Science.
• 5 - 10 years direct experience in pharma/biotech manufacturing organizations, including experience in aseptic GMP manufacturing industry.
• Minimum of two years of demonstrated leadership and behavioral competencies in a similar role.
• Experience in managing different aspects of GMP aseptic production is a must.
• Knowledge of GMP requirements and guidelines (mainly Health Canada, FDA, and EMA).
• Flexibility in work schedule to support a 24/7 production environment

AtomVie Offers

• Group Health & Dental Benefits (from day 1)
• RRSP Matching Program
• Perkopolis
• Employee Assistance and Wellness Programs
• Parking Allowance

AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.