Vice President Operations

Job Description:

The VP Operations is responsible for direction, strategy, planning, and execution of the company’s manufacturing operations.

Oversee all operational activities, including manufacturing, packaging, and production planning.

Job Responsibilities:

1. Drive all GMP and commercial manufacturing activities.
2. In cooperation with Executive Team, develop, plan, and execute strategy for establishing and continuously improving film manufacturing capability at IntelGenx.
3. Work with equipment builders on design, manufacturing, delivery, and qualification of required equipment.
4. Create and prepare equipment specifications, URS development, risk assessment reports, process conformity, qualification, and validation of systems and services.
5. Collaborate with landlord, architect, and suppliers on planning and timely execution of facility upgrades.
6. Ensure that operational activities are performed in compliance with pertinent rules and regulations.
7. Ensure facility and infrastructure compliance with cGMP, regulatory, and quality standards.
8. Manage employees and hands-on operation of the company’s manufacturing function, whether in-house or sub-contracted.
9. In cooperation with Regulatory Affairs and Quality Operations, ensure continuous improvement of the Quality Management System for the Company.
10. Assist in Health Authority audit preparation as needed.
11. Prepare quality documents as per internal procedures.
12. Implementation and coordination of health and safety program.
13. Hire operations personnel in line with manufacturing and HR budget.
14. Cooperate with the R&D department on scale-up and process development activities relating to development projects.
15. Explore contract manufacturing opportunities.
16. Ensure that, as the company grows, manufacturing capabilities meet or exceed all industry and customer requirements for cost, quality, and responsiveness.
17. Work closely with the CEO and R&D on manufacturing plans, goals, and future product innovations.
18. Play an active role in senior-level negotiations with client companies and manufacturing partners.
19. Develop and manage budgeting and budget execution with a focus on product costs and margins.
20. Direct all production control, production process development, material procurement, and shipping/receiving activities.
21. Implement serialization procedures and policy as required.
22. Assume other activities and responsibilities from time to time as directed.
23. Provide orientation and on-the-job training for subordinates and ensure that the authority and responsibility for each position are defined and understood.
24. Ensure that duties, responsibilities, authority, and accountability of all direct subordinates are defined and understood.
25. All other duties as assigned.

Job Requirements:

1. B.S. in Chemical Engineering, Chemistry, or Business discipline.
2. A minimum of 5 years experience in GMP and commercial manufacturing, product engineering, manufacturing engineering, fab management, and/or operations of specialty pharma manufacturing.
3. Experience in materials management, from planning through purchasing, and negotiation and administration of procurement agreements.
4. Established relationships with the full range of worldwide sub-contract manufacturers and familiarity with their capabilities, pricing strategies, and negotiation tactics.
5. Sound administrative skills and well-developed management skills.