- Do you love to drive efficiency and maximize productivity while you oversee a growing manufacturing operation?
- Do you get excited at the thought of reporting into the Founder, Chairman and CEO who is a renowned MIT and Harvard trained Physician and Physicist?
- Can you imagine yourself at a Cambridge, MA company that is on the cusp of rewriting the rules of personalized medicine, mobile diagnostics, and healthcare delivery?
Nanobiosym is seeking an experienced manufacturing and operations engineer to drive efficiency in a wide range of its production operations, including medical and DOD applications. This individual will report directly to the Chairman and CEO and will focus on maximizing productivity, minimizing costs, and carefully qualifying and overseeing manufacturing processes.
A Typical Day:
- Develop manufacturing resource strategies, allocate budgets and tools, in support of Nanobiosym's product platforms
- Establish and approve manufacturing operational objectives and assignments, delegating assignments to staff compliant with ISO and GXP standards
- Help develop and expand the manufacturing team
- Communicate manufacturing issues to executive management, users and staff
- Implement PLM, ERP, Lean Sigma processes and methodologies
Do You Have?
- BS /MS or in biomedical engineering, chemical engineering, or related discipline
- At least 10 years' experience in development of devices or biologics
- Strong background in manufacturing process and product development
- Strong track record in managing both small teams and rapidly growing teams, working knowledge of GLP / GMP systems, ISO, FDA and CE regulations.
- Experience validating aseptic processes
- Capability in identifying and managing external collaborations
- Ability to troubleshoot, solve difficult problems, and develop process improvements
- Attention to detail and careful record-keeping
- Excellent organizational skills and ability to manage multiple projects
- Excellent oral and written communication skills, able to write technical reports and protocols
- Flexible team player excited to collaborate with a highly motivated team.
- Highly self-motivated
- Flexibility in working schedule to accommodate weekend work.
- Manufacturing of medical devices or biologics or DOD applications
- Experience with regulatory submissions and ensuring compliances with regulatory agencies including ISO and ITAR type requirements
- Material sourcing and qualification
- Experience with price negotiations, OEM Supplier Contracts; lean manufacturing
- Packaging and shipping validation
We are smart, passionate, fearless, focused and steadfast in our mission. If we're going to rewrite the rules, we have to work hard, and that means we typically work more than a 40-hour workweek. We do it because we love what we do, and we're working to deliver world class healthcare to the over 7 billion people living on Earth today. Our hard work doesn't go unnoticed; we were awarded the first ever XPRIZE for healthcare for which we are immensely proud.
If all of this sounds like it was written for you, we'd love to receive your application and resume.
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