Person, Text, Face

Associate Director, Process Development - Automation

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

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.

• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration

 

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Senior Director, Global Supply Chain & Materials Manufacturing

Facilities 100641 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job The Senior Director, Global Supply Chain & Materials Manufacturing leads a team of 20+ employees across the United States with a matrix in FMI’s International site to ensure best in class operational performance end to end. This...

Automation Engineer (Tues-Sat 2nd Shift)

Technical Operations 100727 Morrisville North Carolina United States Kit Creek Road, Morrisville, North Carolina, United States Operations
About the Job The Automation Engineer is part of the Process Engineering and Laboratory Automation team responsible for developing, installing, and maintaining automated laboratory systems supporting the clinical assays that will power the future...

Senior Product Owner

Engineering 100754 Boston Massachusetts United States Seaport Blvd., Boston, Massachusetts, United States Technology
About the Job The Sr. Product Owner assists in forming and executing the product vision, with a focus on ensuring that FMI’s products meet the needs of our business partners and stakeholders. By serving as the product owner on multiple high veloc...

Molecular Technologist II (1st Shift)

Lab Operations 100772 Cambridge Massachusetts United States Second Street, Cambridge, Massachusetts, United States Operations
About the Job The Molecular Technologist II position is a key member of the clinical diagnostic laboratory operations staff responsible for performing all aspects of complex patient sample testing, solution and reagent preparation, equipment main...

Send to a friend

Not You?

Thank you for sending this job to your friend.

Person, Clothing, Shoe, Crowd, Sitting, People, Wood, Pants, Face, Coat

Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.