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Head of Operations and Manufacturing [Ref 267467] – Cambridge, MA

Head of Operations and Manufacturing [Ref 267467] – Cambridge, MA

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. Exosomes are messengers released by all living cells into biofluids, such as plasma/serum, urine, cerebrospinal fluid and saliva, forming a highly enriched source of RNA, DNA and proteins from their cell of origin. Our proprietary exosome-based technology platform can yield comprehensive and dynamic molecular insights about cells in the body without direct access to the actual cells. Through this novel technology, we are focused on transforming how cancer and other serious diseases are detected, diagnosed, treated and monitored. In 2016, we launched multiple diagnostics, including liquid biopsy tests for lung, prostate and other solid tumor cancers. In 2017, we will be launching new diagnostic tests and an exosome detection platform.

As we are advancing our commercial operations, we are seeking a Head of Operations and Manufacturing in our Cambridge headquarters to help us with our rapid growth. This position provides an opportunity to participate in a fast-growing entrepreneurial company that is bringing its proprietary technology into clinical laboratory services and In Vitro Diagnostics. The Head of Operations and Manufacturing is the Supply chain, operational and manufacturing expert to the development team, requiring significant leadership skills, ability to execute operational plans on a short term and long term basis and provide appropriate expertise in the management team.

Qualifications:

• Bachelor's degree in engineering (manufacturing, electrical, mechanical, chemical, or biomedical; other disciplines may be considered). MS preferred.
• Excellent working knowledge of supply chain management, operations management and manufacturing of instruments, consumables and reagents.
• Knowledge of FDA regulation, ISO 13485 standard and relevant guidances.
• Knowledge of CLIA regulations a plus, but not required.


Key Responsibilities:
• Develop, implement, and manage Operations Management Systems processes and procedures compliant to FDA QSR (21 CFR 820), EU-IVD Directive and ISO 13485.
• Lead supply chain initiatives for transitioning one or more Laboratory Developed Tests (LDT) to an In Vitro Diagnostic medical device.
• Lead Risk Management initiatives in manufacturing.
• Represent Manufacturing for new and existing product improvement, and quality plan initiatives.
• Lead manufacturing transfers, lab and location moves.
• Support engineering in protocol and design specification development for process validations.
• Lead procedure and process specification development and in performing component qualification, process validations, etc.
• Manage the supply chain processes for the clinical laboratory and IVD manufacturing.
• Lead process improvement efforts and process lean initiatives.
• Will manage/supervise staff.

Experience and Skills:

• 10-15 years’ experience in operations with at least 5 years in a leadership role.
• Operations Management experience.
• Manufacturing leadership experience.
• IVD Manufacturing deployment experience a plus.
• Statistical knowledge (DOE, SPC, hypothesis testing, sample comparison). Prior experience with statistical software a plus.
• Negotiation and problem solving skills.
• Ability to operate and communicate effectively with multiple teams.
• Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems and conflicts.

What we offer:

• Competitive salary/ benefits package and an attractive location in the vibrant Boston/Cambridge community of biotech and academic research.
• Opportunities to enhance your career with an emerging organization poised for significant growth.

How to apply:

Interested candidates should submit a resume (Word or PDF format) to careers@exosomedx.com. Please put [267467] Head of Operations and Manufacturing in the subject line. No phone calls and no agencies, please!