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Associate Director, Process Development - Automation


Location: Cambridge, MA
Job Category: Biotechnology

Associate Director, Process Development - Automation- Fulltime

The Associate Director of Process Development - Automation will be based at our Cambridge, MA laboratory and will report to the Director of Lab Automation in our US Operations Organization. The successful candidate will be reasonable for leading a team of Automation Engineers that develop new automation solutions to support FMI’s clinical and regulated testing laboratories in Cambridge, MA and RTP as well as ensuring harmonization of automation solutions deployed at our Penzberg, Germany site.  

The selected individual will have extensive experience developing and implementing high-throughput automated laboratory solutions for Next Generation Sequencing (NGS) as well as directly managing a team of engineers, scientists, and technical specialists. S/he will also have a strong acumen for program management and process improvement, in order to drive strategic initiatives that ensure that our diagnostic tests continually deliver the highest quality results for our patients today and in the future.   

Key Responsibilities

• Leading a team of Automation Engineers in Cambridge, MA, Durham, NC, San Diego CA and future FMI sites; primarily focused on the development of novel automated laboratory solutions for NGS Diagnostics in a CLIA, CAP, and QSR regulatory environment.

• Ensure the Automation Engineering staff conducts development and deployment activities for applicable systems per relevant Industry standards and quality regulations, including GAMP5, IQ/OQ/PQ, Test Method Validation, Design Change Control, and software version control.

• Responsible for driving continuous improvement initiatives ensuring that automated systems deployed in our Clinical and FDA regulated laboratories operate in a robust and accurate fashion with minimal downtime.

• Collaborate and partner with our Product Development, Information Technology, and Laboratory Operations organization leadership to deliver on continued improvements for existing systems.

• Work with the Quality organization to review, manage, and improve Quality Assurance programs around automated laboratory equipment and instrumentation.

• Direct activities of automation staff in accordance with local regulations and company policies and procedures.

• Develop project plans/proposals and recommend budget, capital equipment, and staffing changes for key business programs/projects in alignment with organizational goals.

• Lead Root Cause Analysis (RCA), Design of Experiments (DOE), Corrective and Preventative Action (CAPA) and similar continuous improvement initiatives as required

• Other duties as assigned.

Qualifications

Basic Qualifications

• Master’s degree in a biological or life science

• 10+ years of experience developing automated laboratory solutions

• 5+ years of experience in a senior leadership/management role

• 3+ years of experience leading a distributed team across multiple sites/programs/initiatives

Preferred Qualifications

• Ph.D in a biological or life science

• Demonstrated industry experience in laboratory automation, liquid handling, software engineering, technology innovation, mentoring/coaching technical staff, and possessing of strong general leadership skills.

• Development and continuous improvement of automated NGS workflows on Hamilton, Beckman, Agilent liquid handling systems and Illumina sequencing platforms

• Experience working in a CLIA/CAP, QSR, cGMP or related regulated laboratory setting

• Must be well-versed in industry leading process improvement practices such as LEAN, Six Sigma, Agile, RCA, CPI, customer success management, and information technology management (ITIL)

• Prior experience facilitating Tech transfer to implement automated solutions in satellite/external labs is a strong plus

• Experience working with Automation in a laboratory with electronic data capture and LIMS

• Demonstrated ability to coach teams to prioritize and complete technical activities in a timely manner

• Demonstrated personal drive to exceed expectation and seek continuous improvement

• Strong organization and administrative skills

• Strong interpersonal skills that include collaboration and creative problem solving

• Excellent oral and written communication skills

• Demonstrated experience leading highly complex, business critical, and cross functional programs.

 


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