Job title: Director of Operations
Reports to: CFO
FLSA Status: Full Time Exempt
Job Overview
Imagion Biosystems, Inc. is looking for a motivated and experienced manufacturing and operations professional to join our growing management team to establish robust manufacturing capabilities to produce the metallic nanoparticles used in our proprietary imaging technology and supplied to 3rd parties for biomedical applications. The Director of Operations will be the senior representative for the company’s manufacturing operations and facilities management. The Director of Operations will ensure nanoparticle products are transitioned from R&D into production including those products outsourced to Contract Manufacturers (CMOs). Products will include research-grade (RUO) products as well as FDA and ISO 13485/MDD compliant products, including OEM or 3rd party products. Candidates must have experience with good manufacturing practices (cGMP) of regulated medical devices and/or pharmaceutical product. The ideal candidate will be self-directed, deadline-driven, detail-oriented, and comfortable working in a fast-paced interdisciplinary team environment.
Primary Duties and Responsibilities
The Director of Operations will be required to:
- Oversee all operational activities related to manufacturing, supply chain, and facilities maintenance to support nanoparticle production.
- Develop and build from the ground up the business practices and infrastructure necessary to support the manufacturing of products being used in clinical development and those commercialized directly or sold to 3rdparties using a combination of in-house production and Contract Manufacturers.
- Hire, train, and manage manufacturing personnel, such as technicians and engineers, as needed to support the business plan.
- Partner with product development and clinical management to execute robust manufacturing processes to ensure products meet specifications/requirements as they transition from R&D into translational, clinical and commercial phases.
- Manage inventories, including raw materials, Work in Process (WIP), and finished goods.
- Ensure the Company is prepared for compliance with the U.S. FDA Code of Federal Regulations, the EU Directives, EN 13485, and other International Quality Standards and local requirements as needed.
- Work with team members and third-party suppliers to establish and maintain the appropriate product documents, needed for the medical device or drug product regulatory filings.
- Establish a manufacturing operation that strives for continuous improvement and delivery of quality product to drive the growth of the business.
- Manage all aspects of maintaining the Company’s San Diego facility.
Qualifications
The Director of Operations qualifications include:
- Bachelor’s degree in business related field or engineering.
- 10+ years of experience in a medical device or pharmaceutical manufacturing leadership role.
- Proven track record of building operational infrastructure for FDA regulated medical devices.
- Hands-on experience in fast paced start-up of operations and supply chain for medical devices or pharma products; including purchasing, planning, inventory control, document control, shipping and receiving and facilities maintenance.
- Prior P&L responsibilities is a plus.
- 3+ years of experience manufacturing of technical products requiring precise control of manufacturing conditions such as temperature, pressure, and use of chemicals.
- 5+ years of experience on product core teams and transitioning from R&D to manufacturing.
- Proficiency with FDA and ISO medical device regulation terminology and requirements.
- Proven track record of successful ISO 13485 certifications and experience in ISO 14971 Risk Management.
- Experience in Chemicals Manufacturing and Controls (CMC) requirements for pharmaceutical products is a plus.
- Experience with a Quality Management e-document system such as QT-9 a plus.
- Prior experience in Project Management a plus.
- Must have excellent written communication skills and willingness to be hands-on with writing policies, procedures.
- Technical acumen, including interpretation of drawings, blueprints, technical instructions, diagrams, etc.
- Strong leadership and communication skills; comfortable presenting to top management.
- Has good general business acumen and strong organizational skills.
About Imagion Biosystems
Imagion Biosystems, Inc. is developing an innovative functional imaging technology for cancer detection using superparamagnetic relaxometry (SPMR). Our MagSense™ system has been designed to detect cancer and other diseases using the magnetic signature of our biofunctionalized PrecisionMRX™ nanoparticles. This detection platform is expected to offer greater sensitivity and specificity than is currently possible with other clinical imaging modalities.
To learn more, visitwww.imagionbiosystems.com
To apply for this position, please send a C.V. or resume to Geoff Hollis: [email protected]
***** Interesting that the position is in San Diego, USA but resume to be sent to Geoff Hollis in Australia. *****
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