Production Project Lead

**General information**:
**Reference**:2025-2116

**Position description**:
**Category**:
Operations - Manufacturing

**Job Title**:
Production Project Lead

**Company Details**:
Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

Our employees are our number one asset We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.

We have an opportunity for a Production Project Lead.

**Job Summary**:
The Production Project Lead is accountable to the Production Manager. The production lead will be responsible for project work, special projects and successfully aligning commercial production with project work. This is done in accordance with the requirements outlined in Standard Operating Procedures and Good Manufacturing Practices.

Internal Job Posting Grade 9B

**Responsibilities**:

- Acts as the Production lead and facilitator for projects working closely with Project Management, and cross functional team.
- Pharma projects
- CDMO projects
- Technology transfer
- Process improvements
- Inter-site harmonization
- Manufacturing compliance
- Represent Production to work 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.
- Create and maintain action plans, project schedules and milestones, resource planning, performance tracking, labour tracking, reports for production and production support activities.
- Coordinate with Supply Chain, Project Management and Production to ensure project line execution dates are planned, communicated and scheduled into the Production plan and schedule.
- Lead and facilitate targeted team meetings effectively; providing clear agenda, objectives, targets, metrics, risks/mitigation actions and minutes.
- Prepare SOPs, Batch records, BOM creation, routings and align AX transactions and other batch documentation for approval and execution, in collaboration with Production, Tech Services and Project Management.
- Prepare training packages, training documentation and coordinate the execution of training to the production team, in collaboration with Production SMEs, Tech Services, and Operations Trainer.
- Champion/Lead a team of SMEs from Maintenance, Production, Tech Services, Project Management and Supply Chain to ensure appropriate inventory of raw materials, components, operating supplies and spare parts.
- Oversees the execution of various studies such as production trials, technology transfer studies, or development and commercial batches on the production floor
- Design optimal production flow layouts, workstation setup and crewing model with support from various departments.
- Collaborate with Project Management and Finance to create the costing model for various commercialization projects.
- Provide pertinent production information for proposals and costing to Project Management, Finance and Business Development.
- Implement and maintain methodology for tracking actual production metrics (cycle times, labour hours, downtime, OEE, scrap, deviation, cost, etc), provide opportunities for improvement and standard reporting.
- Lead Continuous Improvement initiatives to optimize future batch execution.
- Create memos, reports, Power Point presentations, letters, agendas, itineraries, and any other such confidential materials and/or administrative support as required.
- Provides assistance on a wide range of organizational, departmental projects, and other duties as assigned.
- Follows GMP and regulatory requirements and ensures quality standards are met.
- Observes and supports all safety guidelines and regulations.
- Demonstrates the Company Mission, Vision

**Qualifications**:
Education
- Bachelor of Engineering / Science degree is a requirement.
- PMP certification is consi