Director of Operations / Manufacturing

Avenue 45 • Full-time • Greater Boston, US • $200k - $250k / year • 1w ago

Our direct client is looking for a Director of Operations that has a background with In Vitro Diagnostics (IVD) device Manufacturing.

Our client is a well-funded, early stages in vitro diagnostics (IVD) company

Position: Director of Operations
Full-Time Direct Hire
Great Salary range plus RSU
Client Location: Toronto, Ontario Canada area

The Client is open to candidates located in Canada or based in the United States. Must work 2 weeks/month on-site in Toronto, Canada.

Travel Requirement:

50% On-Site - (2 weeks/month) - Must be able to travel and work-onsite in Toronto, Canada, (client covers travel expenses)
50% Remote from Home (2 weeks remote/month)

Director of Operations should have hands on experience with: Operations, Facility, Supply Chain, Running the Site, Automation, Process Engineering,Consumables and Instrument Manufacturing of IVD devices.

Focus will be more on Operations - Overseeing facilities, supply chain, and day to day manufacturing.

Must have solid experience in automation with process engineering.

Education:

Bachelor’s Degree in a relevant field

Experience:

10+ years of industry experience in introducing new products and processes into manufacturing, with specialized knowledge and experience in cGMP manufacturing in the IVD space.
At least 2 years of hands-on working experience with In Vitro diagnostic (IVD) devices.
Min 2 - 4 years of Director Level experience (including hands-on)
Min 5 years of Management with at least 7 - 10 direct reports as well as several Indirect reports.
Experience with Rapid Scale Up in a startup environment as well as Enterprise level.
Experience with complex consumables
Experience with Inhouse operations/manufacturing of IVD Devices (consumables and Instrument)
Has experience with ISO 13485
Experience with cGMP, FDA and regulatory experience
Exceptional organizational and leadership abilities. Strong communication skills for effective debate, persuasion, and collaboration.
Experience managing teams, hands on managers, grow, mentor, coach and guide.
Familiar with global IVD regulations related to the operations/manufacturing of instruments, reagents, and consumables for IVDs, validation/qualification requirements, and recordkeeping.
Provide day-to-day leadership, clear direction, guidance, and performance feedback to the operations/manufacturing engineering team.

Nice to Have:

Experience with lean and Six Sigma methodologies and their application during product development, design transfer, and production scale-up.
Prior experience with high-volume consumable assembly and automation would be a major plus.

Benefits: • Paid time off • Monday to Friday schedule • Full-time, permanent position

Professional Reference Check, background and drug test will be required!

If you are interested, please send me your updated Word Resume, along with your direct phone number and email.

Apply