VP Manufacturing Operations
Are you looking to lead hardware + reagent manufacturing, supply chain, and quality at a biotech startup? Then we have the job for you!
Chai applies the power of molecular diagnostics to real-world applications. By combining our portable qPCR instruments with sophisticated molecular biology, we develop easy-to-use solutions for problems such as COVID surveillance, food & beverage safety, and environmental water quality. Our affordable instruments and open reagent platform are used by some of the most impactful researchers and life science companies around the world.
We're searching for a VP of Manufacturing Operations to lead day-to-day and strategic manufacturing operations including qPCR instruments, PCR reagents, and test kits production, as well as lead all aspects of Quality and Supply Chain.
What You'll Do
- Provide strategic leadership of production operations, ensuring the company's ability to efficiently introduce, manufacture, and distribute quality products within budget and on schedule
- Own hardware manufacturing, including our on-site production for our Open qPCR instrument, repair service, and NPI of future products
- Own biological reagent and test kit manufacturing of our PCR reagent, DNA/RNA extraction buffer, PCR test kit, and future products
- Implement and acquire certification for an ISO13485-compliant Quality System, and manage the ongoing quality process to ensure a high quality of finished goods
- Ensure compliance with all relevant regulatory standards, manage FDA and vendor quality audits and ensure corrective actions are implemented
- Own supply chain management, including vendor selection, inbound and outbound logistics, and planning
- Assume management of an existing team of 5 production personnel; recruit, hire, retain, and grow the team
- Collaborate closely with R&D, Business Operations, Finance, Sales, and Marketing to ensure Manufacturing Operations meet the needs of all customers and the entire company
- BS or advanced degree in an Engineering or Life Science field
- 10+ years manufacturing experience with 5+ years in medical devices or biotechnology
- Strong technical and leadership skills with ability to be decisive, lead and inspire others, and think strategically
- Knowledge of cGMP regulations, ISO 13485, 21 CFR Part 820, and CE-IVD
- A deep background in medical device or reagent manufacturing; ideally both
- Strong organizational skills and a track record of accomplishment in managing multiple, complex projects
- You're an excellent manager of people, know how to recruit, grow, and retain a hard-working, collaborative team
- Expert at selecting, managing, and negotiating with contract manufacturers and vendors
- Competitive salary & equity
- Robust medical, dental and vision benefits
- 401(k) and FSA plans
- Paid holidays and PTO
- Fully stocked kitchen and catered weekly lunch
- An opportunity to make your mark at a growing startup
This is an on-site position in our Santa Clara office. Our workforce is fully vaccinated against COVID-19, and proof of vaccination is required for employment.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.Apply Now