Production Team Lead

4 days ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer 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.

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About the Role*
The Production Team Lead will be responsible for coordinating the day-to-day operations of production lines in the manufacturing facility, including recommending process changes to eliminate repetitive problems ensuring that all work is carried out in accordance with regulatory requirements, AtomVie standards, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)
**What You Will Do**
- Assist in coordinating production runs, cleaning and scheduling of staff to meet production needs, including ensuring clarity is understood in priorities and ensuring resources are used effectively.
- Training staff on AtomVie production lines in a timely manner ensuring their competence to complete production tasks with a high level of consistency in quality, including on SOPs and good documentation practices (GDP) associated with the manufacturing and distribution of drug products
- Directing the team to assure production, quality and safety requirements are met in accordance with the CNSC license and radiation safety programs.
- Act as backup for vacations and absences to manufacture, aseptically dispense and package drug products as instructed in controlled documents
- Support the Manufacturing and Packaging teams by ensuring training is conducted in a consistent, effective, and efficient way.
- Identify and assist in conducting cross functional training between processes to maintain and improve the growth of employee knowledge and the flexibility of production to maintain the schedule
- Ensure that material inventories are maintained such that production needs can be met with mínimal notice
- Work across teams to ensure that equipment is maintained and calibrated to meet production requirements
- Inform Manager of operational, quality and production problems in a timely fashion
- Conduct investigations into batch failures and non-conformances with the goal of identifying a root cause and proposing CAPAs to prevent the issue from reoccurring
- Ensure timely and effective training to support identified Corrective and Preventative Actions (CAPAs)
- Continually assess production requirements and provide recommendations on improving efficiencies
- Adhere to GMP regulations by maintaining complete records pertaining to all aspects of production
- Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
- Understand and work under the Canadian Nuclear Safety Commission regulations
- Monitor training records to ensure cGMP compliance including tracking and trending of applicable metrics.
- Author, revise and review technical documents, including SOPs, validation documents and investigation reports
- Maintain documentation to fulfill all customer, facility, Provincial, Federal and applicable International regulatory requirements relating to nuclear safety and cGMP manufacturing

**Experience Necessary**

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College Diploma or B. Sc. in Engineering, Chemistry, Microbiology or a related field
- 1 to 3 years of relevant experience
- Experience working in a GMP is required
- Ability to lift 23 kilograms required
- Proficiency with spreadsheets (e.g. Excel, Google Sheets), and ability to write technical documents, create clear schedules and reports
- Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
- Flexibility in work schedule to support a 24/7 production environment

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AtomVie offers:*
- Group Health & Dental Benefits
- RRSP Matching
- Transportation Reimbursement
- Training & Career Development
- Opportunity for long-term growth
- Collaborative environment with experienced individuals in the field
- Join a passionate team making a difference in patients’ lives

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