Sr. Director, Manufacturing Technical Operations
Company: GenMark Diagnostics, Inc.
Posted on: February 22, 2021
Sr. Director, Manufacturing Technical Operations Do you want to
join a company where you can be a hero too? We deliver innovative,
diagnostic solutions that improve the lives of patients and their
families and are proud to be one of the heroic diagnostic companies
that is in this fight against COVID-19. As a member of GenMark's
team, you'll get to be part of an organization where we embody our
cultural beliefs in everything we do. The following is a glimpse of
what our culture looks like and If you'd like to join us, we
encourage you to apply as our company is growing!
- Go Big--- We never settle and challenge what's possible
- Win Together--- We are one team with a shared purpose
- Own It--- We step up, drive it, and deliver it
- Be Bold--- We empower ourselves and other WHAT YOU'LL DO AT
GENMARK! As the Sr. Director, Manufacturing Technical
Operations--you will be responsible for the direction and
coordination of Manufacturing Technical Operations functions,
including manufacturing engineering, process engineering, equipment
engineering, and automation functions. This leader will have an
excellent understanding of device manufacturing, including working
with device development and manufacturing to enable manufacturing
at various scales. This leader will foster a strong attitude of
collaboration and work closely with all other groups within the
organization. This person will provide leadership and oversight to
a variety groups within the operations division, including
manufacturing and supply chain, in support of commercial product
efforts. ESSENTIAL DUTIES & RESPONSIBILITIES
- Ownership of designing, sustaining and improving manufacturing
processes with a critical focus on improving yield and gross
- Work with colleagues across GenMark to ensure efficient and
effective production for all product lines.
- Serve as Subject Matter Expert on device manufacturing;
supporting development, manufacturing, investigations, process
improvements, validations, regulatory filings, technical documents,
- Work with suppliers and contract manufacturers on tech
transfer, process installation, process qualification, and ongoing
- Lead a team of technical experts to support manufacturing and
translate business requirements into process changes in support of
product and manufacturing strategies.
- Ensure ongoing technical support for all manufacturing
processes both internally and/or at contract manufacturing sites
and directing global initiatives and cross-functional teams of
subject matter experts in manufacturing.
- Driving innovation and communication of latest industry trends
and best practices for process design and manufacturing to ensure
consistency. POSITION REQUIREMENTS
- Minimum of BS degree with a scientific or engineering
- 10+ years of operational or engineering experience in a
Biotechnology, Medical Device or Pharmaceutical manufacturing
- Demonstrated knowledge of biomaterials and biotechnology device
- Experience establishing and maintaining robust validation and
process control strategies.
- Several years leading and managing a team of dedicated
engineers, scientists and technicians.
- Strong engineering skills, including facility fit and process
engineering assessment into different facilities.
- Strong Lean Six Sigma or alternate continuous improvement
skills for root cause analysis.
- An understanding of design control elements required for
medical or in-vitro diagnostics devices.
- Able to apply principles of mechanics, microfluidics, and
materials to understand the mechanical design of complex plastic
parts and assemblies.
- Able to apply basic biologic principles including nucleic acid
sample preparation and PCR amplification to understand assay
performance on the consumable platform.
- Experience with plastic assembly techniques such as ultrasonic
and laser welding.
- Advanced experience with root cause analysis, design of
experiments, and data analysis.
- Experience with qualification, verification, and validation
requirements as related to parts, equipment and products. ABOUT
GENMARK GenMark's ePlex true sample-to-answer system symbolizes the
evolution of eSensor technology combined with digital
microfluidics. ePlex offers unique solutions to address the most
significant challenges facing clinical laboratories, while
supporting hospital systems to deliver patient-centered,
value-based care. ePlex streamlines the diagnostic workflow from
physician order entry to the final test report, and is the only
true sample-to-answer solution designed to improve patient care,
reduce costs, and increase lab efficiency.
Keywords: GenMark Diagnostics, Inc., San Diego , Sr. Director, Manufacturing Technical Operations, Executive , Carlsbad, California
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