Director/VP, Technical Operations (Life Science Tool)
CytoTronics is disrupting biology wet-lab workflows with its innovative engineering approach. Leveraging semiconductors, our patented microchip consolidates functionalities from incumbent technologies into every well of a microplate. With significant improvements to resolution and parallelism, we enable applications never possible before and give customers the power to scale assays to unprecedented throughputs.
Our market potential is substantial ($4B+) as our technology is ubiquitous and applicable to any cell type, yet, we have identified killer applications where we will quickly establish dominant market positions. Our initial target customers are upstream drug discovery groups from biotech, pharmaceutical companies and CROs. Our products complement the incumbent tools used in traditional wet lab facilities, and will also be drawn upon by the thousands of academic and non-profit biopharma research labs that will see CytoTronics as invaluable a tool as a microscope.
As the Director of Technical Operations for CytoTronics you will initially be a single contributor to set the framework and establish best practices. It is expected that as the company grows, you will recruit members to join your team responsible for Design for Manufacturability (DFM), UL/CE compliance, on-market support, technical issue resolution, process improvements, and key vendor/supplier/integrator management.
This is a phenomenal opportunity for an experienced technical operations manager who will spearhead a revolutionary class of measurement and manipulation technology in the life science tool industry.
This role reports to the Chief Technology Officer (CTO). This is an on-site role at our Boston office, requiring in-person attendance multiple days a week when needed.
· Management of product manufacturing, including budgeting, resource allocation, operational planning, and ownership of in-house, contract manufacturing, and primary supplier (US and Asia) relationships.
· Lead the implementation of document control system such as Agile PLM or Ominfy PLM.
· Lead the implementation of an Enterprise Resource Planning (ERP) system.
· In conjunction with engineering peers, evaluate the technical capabilities of outsourcing providers and make recommendations.
· Collaborate with external manufacturers, customers, and key partners, providing technical support as needed.
· Manage the inventory for newly manufactured products (instruments, accessories, and consumables) as well as re-conditioned accessories and consumables. Manage product return, services, refurbishment workflow and process.
· Contribute to the development of new processes and technologies to improve cost-effectiveness and product quality. Identify and address opportunities for quality, delivery, and cost improvement.
· Support design and product development teams to ensure manufacturability, robust product/process development, technology transfer, and manufacturing scale-up.
· Establish metrics and monitor manufacturing process/product performance trends to maintain quality requirements and specifications. Review with the leadership team (CEO, CTO, CBO) on a quarterly basis.
• Bachelor's degree in a scientific field
• Ideal candidates will have at least 7 years’ experience as a Snr Manager or Director of Technical Operations in a medical device or other scientific analytical instrument manufacturer.
• Small company up/or start-up experience required.
• Specific electro-mechanical and/or PCB/PCA manufacturing and structure experience
• Knowledge of ERP systems and their implementation and ongoing usage
• Initial quality responsibility for all outgoing systems
• Familiarity with regulatory requirements and quality standards in the biotech/pharmaceutical industry
• Any candidate for this function must understand going in that this type of fast-paced VC-backed high-impact biotech environment is not for everybody. The candidate must understand that they will need to wear several hats and be very self-sufficient.
• Be able to forge good if not great working relationships with your peer in the engineering and software groups.
• Agency compliance UL, CE, ISO, cGMP experience a plus
• A minimum of three professional references will be required.
The people that we seek have:
· An openness to other ideas, approaches, and methods
· Failures that exposed learning moments and insights to build upon
· Ability to communicate as part of a broader vessel – not an isolationist.
· The end in mind – we are building a business not just a technology.
· A passion to build a venture, not just show up for a job or task.
This role is full-time and on-site at the company location in Boston Southend. CytoTronics is an equal employment opportunity employer in the United States.