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The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.

Watch the video to see how each member has the chance to make a real impact. 

 

Associate Director, Development Operations

  • Cambridge, Massachusetts, United States
  • Full Time

Key Responsibilities

• Manage, author and lead development, verification, and validation studies for novel diagnostic next generation sequencing assays.

• Manage a team comprised of scientists and research associates and conduct hiring, performance review, and development activities for direct reports.

• Manage training and performance qualification testing during tech transfer between the development and operations teams.

• Manage a team supporting product documentation in fulfillment of QSR design control, and ensure optimal documentation of:

·   CDx assay requirements;

·   Functional specifications;

·   Performance and study results; and,

·   Data management.

• Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.

• Work collaboratively cross-functionally to establish and validate performance parameters, quality control, and stability specifications.

• Support the timely processing and reporting of oncology samples to internal and external collaborators.

• Manage and author detailed, accurate, and accessible records of experimental data.

• Present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA).

• Other duties as assigned.

 

Qualifications

Basic Qualifications

• Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field

• 8+ years of experience in a laboratory setting in the life sciences industry and/or academia

 

Preferred Qualifications

• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field

• 10+ years of working experience in in the life sciences industry and/or academia in a laboratory setting

• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment

• Prior experience managing a team of scientists of all levels

• Prior working experience:

·   In product development, assay development, and clinical services;

·   Developing, implementing and supporting high complexity clinical assays in a regulated environment (such as with FDA-QSR, CLIA, CAP, ISO regulations);

·   Writing standard operating procedures, validation protocols and data reports adherent to regulations;

·   Communicating with regulatory bodies and participating in audits; and

·   Utilizing robotic liquid handlers, lab automation and instrumentation

• Ability to work well under pressure while maintaining a professional demeanor

• Excellent organizational skills and attention to detail

• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow

• Demonstrated track record of timely completion ahead of deadlines

• Demonstrated ability to work in a dynamic fast paced team environment

• Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues

• Understanding of HIPAA and importance of privacy of patient data

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