Manager, Manufacturing Operations, Molecular Diagnostics
Are you an experienced operations/manufacturing manager who would like to be part of a team applying the latest molecular diagnostic techniques to real-world applications? Then we have the job for you!
By combing 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 Manufacturing Operations Manager to lead our reagent and qPCR test kit manufacturing and supply chain, and to drive efficiency and quality improvements. This position reports to the COO.
What You'll Do
- Plan, implement, and manage long-term biological production activities, process improvements, NPI, ECOs, and validations
- Create and implement production plan of Real-Time PCR Test Kits, PCR Master Mixes, and DNA/RNA extraction solutions
- Implement all aspects of an ISO13485 compliant quality system as it pertains to biological manufacturing
- Establish an organized department structure and hire and develop production scientists, production technicians, and quality personnel
- Evaluate, select, and manage suppliers; maintain supplier quality and good vendor relationships
- Design, modify, scale, and maintain manufacturing processes, including appropriate use of automation
- Manage supply chain including supplier quality, inventory levels, and purchasing
- Proactively implement quality and productivity improvements (reduce COGS, increase efficiency, equipment acquisition)
- Manage OOS and CAPA non-conforming events by driving root cause analysis, troubleshooting, and resolution of quality issues and implementing corrective actions
- Work with finance to ensure cost accounting is accurate, and identify variances and cost reduction opportunities
- PhD or MS with equivalent experience in Life Sciences, Biological, Chemical, Biochemistry, or related field
- 7+ years experience in biotech manufacturing operations including 3+ years in a management role
- Extensive knowledge of quality systems and ISO 13485
- Strong understanding of FDA and CE-IVD regulatory guidelines and cGMP
- Ability to handle FDA inspections and supplier quality audits
- Excellent manager and leader of people
- You have a solid understanding of molecular biology, and are able to own the troubleshooting of experiments and quality issues
- Excellent verbal and written communications skills
- Previous experience with start-ups is a plus
- 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.