VICE PRESIDENT OF MANUFACTURING
Who We Are
Hound Labs is a breath technology company that has developed ultra-sensitive technology for non- invasive breath measurement. Utilizing this groundbreaking technology, the Hound® marijuana breathalyzer is the world’s first breathalyzer to rapidly, accurately, and inexpensively measure recent marijuana use and alcohol in a person’s breath. The Hound breathalyzer is intended for law enforcement, employer, and insurance purposes only. Founded in 2014, the Oakland-based company was created by Dr. Mike Lynn, an ER physician, reserve deputy sheriff, and former venture capitalist, his co-founder, Mr. Kuni Oh, a patent attorney with a deep background in engineering and science, and his co-founder, Ms. Jenny Lynn, a business executive with twenty years of experience launching new ventures. Benchmark, Icon Ventures, Intrinsic Capital Partners, Main Street Advisors, NFP Ventures, and individual investors have funded the Company.
About the Role
Hound Labs is seeking an experienced leader to play a critical role on our team as we create leading edge diagnostic systems and applications. The Vice President of Manufacturing will work with our contract manufacturing partners while simultaneously defining and building Hound Labs’ internal capabilities regarding planning, sourcing, and quality and regulatory oversight. The successful candidate will have extensive experience working with contract manufacturers producing cGMP compliant FDA regulated products governed by 21 CFR part 820 and will be able to take a hands-on approach to establishing systems, managing relationships, and resolving issues. In addition, the VP of Manufacturing will be responsible for implementing and overseeing Hound’s repair and technical support capabilities. This position will report directly to the Chief of R&D.
Specific Duties and Responsibilities
• Oversee and lead interactions with contract manufacturing partners to assure continuity of supply that is on-time, meeting quality expectations at expected and established prices
• Manage all planning, sourcing, contract manufacturing and distribution of Hound labs products through a leveraged (outsourced) model
• Establish and maintain the necessary manufacturing service agreements (MSA’s) and Quality Agreements with each supplier
• Manage and ensure the timely review and release of product from contract manufacturing partners
• As needed, act as person in the plant for CMO start-up and manufacturing activities
• Proactively develop, manage and improve contract manufacturer performance, set targets and monitor KPIs, and lead continuous improvement projects (internally and externally)
• Serve as primary point of communication/escalation for issues
• Develop and review metrics with suppliers and internal teams
• Communicate and facilitate all change management with suppliers
• Ensure implementation of the Quality Plan with the suppliers including planned deviations, CAPA, OOS, and other quality events as they arise
• Develop and sustain a Sales and Operations planning rigor with the contract manufacturers and Hound to ensure capacity, inventories and forecast remain aligned
• Develop sourcing recommendations
• Support the development and implementation of CMO management processes and governance structures
• Develop strategy for repair and refurbishment capability; implement and oversee execution
• Develop strategy for product technical support; implement and oversee execution
Qualifications
• Bachelor’s degree in relevant scientific, engineering, or business discipline
• 10+ years of directly related cGMP manufacturing experience, including at least 8 years of management/ supervisory experience
• Highly developed organizational and leadership skills
• Process development or technology transfer experience a plus (proven track record of new product and sustaining support with contract manufacturers)
• Practical experience with 21 CFR Part 820 implementations with contract manufacturers
• Ability to prioritize effectively to deliver results within established timelines
• Ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Direct supplier quality experience a plus
• Prior experience in manufacturing of testing equipment for drugs of abuse is a plus
• Ability to travel up to 30%