Process Development, Manager / Senior Manager
The Senior Manager of Process Development will be responsible for leading the development of robust manufacturing processes for novel polymer technologies designed at Hyalex. Additionally, the selected candidate will be responsible for converting pilot-scale physical and chemical processes to full scale, quality-controlled production systems that support the quality manufacture of medical devices for clinical studies as well as providing day to day support for GMP manufacturing.
This is a hands-on leadership role that requires working on-site in our laboratory including daily interaction with cross-functional team members from chemistry, bioengineering, preclinical, clinical, design, product development, and manufacturing. Additionally, this high-visibility role will interact regularly with members of the Hyalex executive committee, advisors and board of directors.
Primary Responsibilities
- Design, develop, build, troubleshoot and qualify prototype, pilot, and full-scale manufacturing processes utilizing a Quality by Design (QbD) approach as appropriate
- Act as a key technical resource for Manufacturing, from raw material management, to wet chemistry processes, inspection and packaging
- Lead the planning and coordination of all process development activities to launch and commercialize new products
- Lead the execution of validation projects and the collection of data to support completion of process validation activities
- Lead team members to develop and release product and process documentation including SOPs, Work Instructions and incoming inspection requirements
- Lead team members by example in promoting a positive, disciplined and scientific approach to process development
- Maintain good documentation practices for GMP compliance
Qualification / Work Experience
- BS in Chemical Engineering required, advanced degree preferred (MS, PhD, MBA)
- 10+ years of industry work experience required, including people management
- Experience in medical device process development, technology transfer, validation and GMP manufacturing required
- Experience in biotech or pharmaceutical process development also considered
- Experience working in ISO 13485/GMP manufacturing and clean-room manufacturing/process environment preferred
- Experience include polymer processing, operation of controlled mixing processes, operation of controlled motion, temperature and pH systems, device sterilization, sterile filtration and wet packaging preferred
- Strong written and verbal communication skills including ability to work collaboratively with cross-functional team members
- Strong technical leadership and analytical skills, with appropriate attention to detail
- Pro-active attitude, high level of ownership, flexible, professional, self-motivated, hands-on, strong work ethic, team player
- Must be authorized to work in the U.S.
Benefits
Health Insurance
Dental Insurance
Health Savings Accounts (HSA)
Short / Long Term Disability
Paid Time off
Paid Holidays
Paid Parental Leave
Retirement Plan
Tuition Reimbursement
Why Hyalex?
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. 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.
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.
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.