Vice President of Technical Operations
Vice President of Technical Operations
Hyalex Orthopaedics is an award winning, venture funded medical device start-up developing transformational synthetic cartilage technology and implant systems for diseased and damaged joints. We address unmet clinical needs to improve patient quality of life so that we all can Be Active and Stay Active. Our Hyalex team is comprised of industry leaders, innovators, and experts who have developed and launched many successful commercial products as well as a team of brilliant engineers, scientists and medical professionals.
The Vice President, Technical Operations leads the development and execution of our technology, manufacturing, and operations strategy for the Company. The individual provides leadership, strategic direction, and coordination of all activities required to develop, produce, and scale our proprietary HYALEX® materials platform for human clinical use and global commercialization. This includes leading the team in continuous improvement efforts and partnering with Quality and Regulatory to support market introduction of new products, implementation of clinical trials and continued compliance with domestic and foreign regulations.
The selected candidate will be a member of the executive leadership team and lead a world-class organization including Analytical Chemistry, Process Engineering, Manufacturing and Operations. This role reports to the CEO.
Role and Responsibilities
- Lead technology strategy for company’s proprietary HYALEX® materials platform
- Lead scaling of chemical processes and operations
- Support manufacturing transfer, including process validation for novel products for human clinical studies and worldwide commercialization
- Develop and coordinate efficient manufacturing processes on-site and with third parties
- Establish license and supply agreements with key external vendors in support of the product development objectives
- Support ISO 13485 qualification and compliance
- Support regulatory approvals for domestic and foreign markets
- Build a culture of teamwork and excellence in a fast-paced, lean environment
- Lead site-operations for our Lexington, MA location
- Other duties as may be assigned from time to time
- BS/MS/PhD Chemical Engineering required
- 15+ years of related work experience including 5+ years as a people manager
- Ability to operate in fast-paced, collaborative, cross-functional team environment
- Strong ability to establish credibility with a broad range of constituents inside and outside of the company
- Creative problem-solving ability and willingness to take risks and act decisively while communicating potential consequences to ensure that informed business decisions are made
- Self-confident and willing to defend beliefs while maintaining flexibility
- Passionate, results-oriented executive who thrives in dynamic and challenging business cultures
- An analytical mindset and fact-based decision maker
- Commitment to excellence
- FDA GMP and GLP
- Class III/PMA products
- ISO 13485
- Quality Systems
- Wet-chemistry process development and operations
- Advanced biomaterials and polymer processing
- Raw material qualification
- Process validation
- Manufacture of permanent implants
- Clean room qualification and operations
- Cartilage and orthopaedics experience a plus, but not required
Hyalex values are focused on teamwork, communication, innovation, integrity, and accountability and all team members strive to promote an inspirational and productive workplace. Every team member’s contribution is valued as we work towards a common goal of transforming orthopaedics.
The health and safety of our team members is our primary concern, especially during the COVID-19 pandemic. Beyond compliance with all local, state and national requirements we have taken additional measures to support the safety of our on-site operations and personnel in Lexington, MA.
What we offer:
- Competitive compensation and generous stock options
- Comprehensive medical, dental and vision benefits
- Pre-tax savings plans for healthcare and childcare
- 401(k) retirement plan
- Generous paid time off (PTO)
- Short-term and long-term disability insurance and an employee assistance program
- Life Insurance
- Tuition reimbursement
- Paid parental leave
- The opportunity to work with driven and enthusiastic colleagues in a fast-paced and entrepreneurial environment, on problems that matter in a highly collaborative environment
Important notice to Employment businesses/ Agencies
Hyalex does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Hyalex human resources department to obtain prior written authorization before referring any candidates. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Hyalex. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Hyalex. Hyalex shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Process Engineering, Technology Development, Operations, Manufacturing, Quality, Supply chain
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