At Septodont, a global leader in dental products and a key player in pharmaceutical development and contract manufacturing (CDMO), we are proud to work every day to improve patients’ health and well-being.
Present in more than 110 countries, the Group relies on the energy, expertise, and passion of 2,600 employees. With 6 international production sites, Septodont combines industrial excellence, technological expertise, and innovation to meet the needs of healthcare professionals worldwide.
In North America, our operations include facilities in Ontario, Quebec, and Pennsylvania. Our Cambridge, Ontario site is home to Novocol Pharma – a thriving center of innovation with over 40 years of expertise in sterile injectable cartridges and combination product manufacturing. Backed by a team of more than 675 dedicated professionals and modern facilities, we deliver high-quality, customer-focused solutions to partners around the world.
Beyond our expertise, our people are our greatest strength. We foster a stimulating work environment where everyone can learn, grow, and build a career that reflects their aspirations, supported by continuous training and internal mobility. As a socially responsible company, we place diversity and inclusion at the heart of our development, convinced that they enhance collective performance and foster human experience.
Joining Septodont means becoming part of a human-scale international group and contributing to a meaningful mission: improving health for as many people as possible. What if your next professional chapter started with us?
We have an opportunity Lead Hand III!
This position is starting at $34/hour.
FUNCTION SUMMARY:
The Lead Hand III is accountable to the Production Supervisor for all compounding or filling manufacturing activities occurring on the shift. This would refer to the operation of the unit, allocation of resources, execution of development and commercial batches and effective escalation of issues relating to the equipment and work areas, quality concerns or operational deficiencies. In addition, the Lead Hand III will ensure the adequate levels of supply are stocked related to the operation including gowns, operating supplies and other PPE. The Lead Hand III will be required to be familiar with various format parts, component size variations, compounding tank variations including all peripherals and product specific requirements associated with Pharma manufacturing. Main responsibilities are related to equipment operation, training, documentation, and continuous improvement to meet the Company’s objectives and in accordance with the requirements outlined in the Standard Operating Procedures and Good Manufacturers Practices.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Coordinates shift changeover to ensure machinery and human resources are performing/scheduled optimally. Reports any deficiencies in machinery, materials or human resources immediately to shift supervisor for timely resolution
- Maintain engagement with the production schedule to help proactively organize the team for future activities
- Acts as a subject matter expert for equipment, product and process related items. Understands the complexity and variation of Pharma related and product specific requirements at line and drives awareness of these items to the team
- Supports the introduction of new processes and equipment by becoming an expert with the equipment/process. Participates in the generation of SOPs, guidance documents and training programs to ensure information is properly cascaded through the remainder of the team
- Accountable to provide timely and pertinent updates to the Shift Supervisors and Managers
- Accountable to produce a quality product, on-time and right the first time. Required to escalate any risks to achieving this promptly to PRD Leadership
- Actively participates in and supports the continuous improvement initiatives projects. Collaborates with the other supporting departments on reactive and proactive initiatives
- Performs the operator’s duties as necessary
- Ensures the availability of component and operating supplies. Maintains guidance documents to reflect the operating supplies required for the various Pharma products/formats
- Reviews executed batch documents for completeness, accuracy of information and compliance with GDP
- Responsible for driving corrective and preventative actions to fix documentation errors and reduce future occurrences through the training and coaching of operators
- Responsible to familiarize the team with document architecture and complexity of Novocol Pharma CDMO batch documents and supporting documents
- Coaches and trains the team on how to access pertinent Pharma and CDMO documents and parameters
- Ensures that working areas are clean and organized through the completion of routine inspections. Specific focus is paid on eliminating risks of cross contamination and damage to equipment by ensuring product dedicated equipment is stored and identified properly
- Initiates, investigates and rectifies Quality events by utilizing the root cause analysis and corrective action tools provided by Quality assurance. Completes all investigation reports in a timely manner as outlined by batch release requirements
- Takes a leading roll in troubleshooting efforts related to equipment and resources by implementing immediate corrective action and/or involving maintenance. Escalates equipment and personnel related issues immediately to Production Leadership to ensure the root causes are properly addressed (mechanical corrections, personnel training)
- Participates in revision of departmental SOP’s and other GMP documents
- Conducts on-the-job training including review of related SOP’s for new employees
- Enters accurate AX transactions. Completes and/or reviews documentation entries in batch record and logbooks
- Responsible for coordinating, planning and scheduling employee work rotations to minimize downtime on the line while complying with published guidelines
- Coordinates and communicates priorities with other shifts via electronic and in-person communication
- Follows all Aseptic practices and behavior while involved in Aseptic processes.
- Understands the first air principal to avoid cross contamination of products and their components
- Understands basic Microbiology
- Follows proper cleaning and sanitization techniques
- Follows GMP and regulatory requirements, and ensures quality standards are met.
- Interacts with clients, regulators and external vendors during in person visits, tours or audits
- Model the desired behaviour expected of the team as it pertains to quality, mental focus, attention to detail and effective communication
- Observes and supports all safety guidelines and regulations
- Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
- Performs other related duties as required
- Represents Production while working closely with cross functional project team (Production, Maintenance, R&D, QA, QC, Tech Services, Supply Chain and Project Management) through the project life cycle to achieve the project deliverables and milestones
- Works with the Production Project lead in creating and maintaining action plans, schedules and milestones, resource planning, performance tracking, time tracking
BASIC QUALIFICATIONS:
Education
- High school completion, college certification/diploma or working towards completion
Experience
- 2 years’ experience in pharmaceutical manufacturing or a related environment. Previous leadership experience is an asset
- Demonstrated leadership and interpersonal skills with the ability to positively interact with interdepartmental teams
- Demonstrated mechanical and troubleshooting skills
- Ability to work independently in a varied, high pressure environment
- Strong communication skills, both written and verbal
- Flexibility to occasionally work outside of normal working hours
- Independence with a proactive approach to solving problems; innovative thinking and meeting challenges tenaciously with a positive attitude
- Proven ability to lead, execute, solve problems and achieve goals
Work Authorization: Applicants must be legally authorized to work in the country where the position is based for the duration of employment. This position is not eligible for employer-sponsored immigration support.
We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.
In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.
Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.
