Solstice Advanced Materials · 2 months ago
Senior Advanced R&D Engineer/Scientist
Buffalo, NY
Full-time
Onsite
Senior Level
$110K/yr - $145K/yr
5+ years expSolstice Advanced Materials is a leading global specialty materials company that advances science for smarter outcomes. They are seeking a Senior Advanced R&D Engineer/Scientist to ensure that appropriate cGMP Quality Systems are in place and to manage quality assurance processes for cGMP products.
ElectronicsHeating Ventilation and Air Conditioning (HVAC)ManufacturingSemiconductor
Responsibilities
Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11
Final responsibility and authority to approve or reject HON cGMP product
Oversee activities concerning customer complaints and/or adverse events that include performing prompt investigations, instituting corrective actions where appropriate and identifying trends
Notify senior management of significant product quality issues and coordinate response
Manage training matrix
Interface with cGMP Customers and regulatory agencies as necessary
Review, approve and uphold internal and external quality agreements
Execute cGMP document control procedures
Conduct and host internal and external cGMP quality system audits
Coordinate quality system improvement projects
Qualification
Required
Bachelor's degree in Chemistry, Chemical Engineering, or Quality Assurance management, Advanced degree is preferred
5+ years of experience in cGMP Quality Assurance related to cGMP production of drugs or drug excipients
2+ years of experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant
2+ years of experience in conducting and hosting cGMP compliance audits
Preferred
2+ years of experience of pharma and industrial aerosol formulation development
2+ years of experience with common chemical process unit operations is preferred
Experience with managing cGMP quality processes such as deviation investigation, CAPA, and change controls
Experience with design, execution and reporting of cGMP validation protocols
Lead auditor certification
Excellent interpersonal and communication skills
Reliable and trustworthy with highest ethical standards
Flexible to work across cultures and time zones
Understanding of industry standards and security practices
Ability to lead, motivate, develop and mentor others
Benefits
Employer-subsidized Medical, Dental, Vision, and Life Insurance
Short-Term and Long-Term Disability
401(k) match
Flexible Spending Accounts
Health Savings Accounts
EAP
Educational Assistance
Parental Leave
Paid Time Off (for vacation, personal business, sick time, and parental leave)
12 Paid Holidays
Company
Solstice Advanced Materials
Solstice Advanced Materials is a global leader in refrigerants, semiconductor materials, protective fibers, and healthcare packaging.
1001-5000 employees
H1B Sponsorship
Solstice Advanced Materials has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$1B2025-10-30IPO
2025-09-16Debt Financing· $1B
Recent News
2025-12-09
Company data provided by crunchbase