Associate Director, Companion Diagnostics at Foundation Medicine in Cambridge, MA
About the Job The Associate Director, Development Operations works on Companion Diagnostics (CDx) of new NGS-based assays through the full development lifecycle and regulatory strategy, from concept through commercial launch. This position manages laboratory and documentation activities in collaboration with a cross-functional team to verify and validate product requirements, assay design, and assay performance, and manages a team of validation scientists and research associates. The Associate Director, Development Operations leads the product development lifecycle, from feasibility through PMA or sPMA submissions to the FDA, and continued support of product and scope expansion. Regular onsite work at a designated FMI location is an essential function of this role. Key Responsibilities o Manage, author and lead development, verification, and validation studies for novel diagnostic next generation sequencing assays. o Manage a team comprised of scientists and research associates and conduct hiring, performance review, and development activities for direct reports. o Manage training and performance qualification testing during tech transfer between the development and operations teams. o 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. o Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards. o Work collaboratively cross-functionally to establish and validate performance parameters, quality control, and stability specifications. o Support the timely processing and reporting of oncology samples to internal and external collaborators. o Manage and author detailed, accurate, and accessible records of experimental data. o Present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA). o Other duties as assigned. Qualifications Basic Qualifications o Master's Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field o 8
years of experience in a laboratory setting in the life sciences industry and/or academia Preferred Qualifications o Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field o 10
years of working experience in in the life sciences industry and/or academia in a laboratory setting o Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment o Prior experience managing a team of scientists of all levels o 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 o Ability to work well under pressure while maintaining a professional demeanor o Excellent organizational skills and attention to detail o Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow o Demonstrated track record of timely completion ahead of deadlines o Demonstrated ability to work in a dynamic fast paced team environment o Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues o Understanding of HIPAA and importance of privacy of patient data Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. About Foundation Medicine Foundation Medicine, Inc. (FMI) began with an idea-to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives. 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.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
CDx assay requirements; Functional specifications; Performance and study results; and, Data management. o Partner collaboratively with the Regulatory Affairs and Quality Assurance Teams to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards. o Work collaboratively cross-functionally to establish and validate performance parameters, quality control, and stability specifications. o Support the timely processing and reporting of oncology samples to internal and external collaborators. o Manage and author detailed, accurate, and accessible records of experimental data. o Present results at group meetings, to external collaborators, and preparation of reports for submission to regulatory agencies (FDA). o Other duties as assigned. Qualifications Basic Qualifications o Master's Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field o 8
years of experience in a laboratory setting in the life sciences industry and/or academia Preferred Qualifications o Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field o 10
years of working experience in in the life sciences industry and/or academia in a laboratory setting o Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment o Prior experience managing a team of scientists of all levels o 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 o Ability to work well under pressure while maintaining a professional demeanor o Excellent organizational skills and attention to detail o Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow o Demonstrated track record of timely completion ahead of deadlines o Demonstrated ability to work in a dynamic fast paced team environment o Strong interpersonal skills that include excellent skill in collaboration and problem solving with other departments and colleagues o Understanding of HIPAA and importance of privacy of patient data Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law. About Foundation Medicine Foundation Medicine, Inc. (FMI) began with an idea-to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives. 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.
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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