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VP/Director of Manufacturing (Molecular Diagnostics)

Employer
Biofidelity
Location
Morrisville, NC
Start date
Sep 11, 2022

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Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Bio NC
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Job Details

Biofidelity’s mission is to improve and extend the lives of patients with cancer by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care. 

At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges. 

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision coverage, 401(k), bonus, stock options, 20 days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

The role
Biofidelity is seeking an experienced, efficient, dynamic and results-oriented VP/Director of Manufacturing to lead the creation, development, implementation, and continuous improvement of business and manufacturing processes and methods to ISO 13485. The role will focus on transferring existing processes from product development, and implementing and ensuring capability of new processes to drive reliability, predictability and efficiency in manufacturing operations. This position reports to the Chief Operating Officer.

Key responsibilities:
●      Define and execute manufacturing strategy to build a new capability, from the ground up, for manufacture of ASPYRE-Lung RUO kits
●      Work closely with the Product Development team to transfer ASPYRE-Lung from development into manufacturing, including development and implementation of novel quality-control assays and automation
●      Manage procurement and relationships with external vendors
●      Work closely with the Quality team to ensure that manufacturing processes and procedures adhere to ISO 13485:2016
●      Lead in the development of a problem-solving culture, integrating Lean thinking into the culture and organisation
●      Drive continuous improvement efforts through data and systematic processes
●      Build, train, and mentor the manufacturing team
●      Actively engage with cross-functional stakeholders across company to effectively support the operations 
 
Knowledge, Skills, and Abilities:
●      Successful track record of operational excellence and continuous improvement of manufacturing operations within molecular diagnostics
●      Demonstrated experience working cross-functionally and collaboratively across different teams (including Technology development, Product development
Computational, Quality, Clinical laboratory, Finance and People)
●      Results-oriented with entrepreneurial and flexible mindset and ability to multitask in a small, fast-growing company
●      Strategic thinker with ability to focus on specific tactical needs and operational side of the role as we build the team
●      Strong leadership, interpersonal and communication skills 
 
Requisite Education and Experience / Minimum Qualifications: 
●      Proven experience leading manufacturing operations in the molecular diagnostics industry, including the transfer of new products into manufacturing, through commercial launch and scale-up
●      Educated to Master’s or PhD level in Biological Sciences or similar

Company

Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care. At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.

Find Us
Website
Phone
+44 1223 981750
Location
Cambridge, UK, Remote and RTP,NC
United Kingdom
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