Senior Advanced R&D Engineer​/Scientist

Apply for the Senior Advanced R&D Engineer/Scientist role at Solstice Advanced Materials
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Solstice Advanced Materials is a global supplier of fluorine products, fine chemicals, additives, and advanced materials used in pharmaceuticals, refrigeration, semiconductors and military protection. We are committed to innovation and are seeking a seasoned QA leader to strengthen our cGMP manufacturing teams.

• Manage the cGMP Quality System to meet the requirements of FDA 21 CFR Part 211 and 21 CFR Part 11.
• Hold final responsibility for approving or rejecting cGMP product releases.
• Oversee customer complaints and adverse event investigations, implement corrective actions and identify trends.
• Notify senior management of significant product quality issues and coordinate response.
• Manage training matrix and document control procedures.
• Interface with cGMP customers and regulatory agencies as necessary.
• Review, approve and uphold internal and external quality agreements.
• Conduct internal and external cGMP quality system audits.
• Coordinate quality system improvement projects.

• Bachelor’s degree in Chemistry, Chemical Engineering or related discipline (Advanced degree preferred).
• 5+ years of cGMP Quality Assurance experience in drug or drug excipient production.
• 2+ years applying FDA 21 CFR Part 211 and Part 11 in a chemical manufacturing environment.
• 2+ years conducting and hosting cGMP compliance audits.
• Experience in deviation investigation, CAPA, change control and validation protocols.
• Lead auditor certification is a plus.
• Excellent interpersonal and communication skills; high ethical standards.

Annual base salary range: $134,000 – $167,000 plus competitive benefits including medical, dental, vision, disability, 401(k) match, flexible spending accounts, paid time off and 12 paid holidays.

Solstice Advanced Materials is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, gender identity or expression, disability, nationality, sex, religion or veteran status.

Solstice Advanced Materials is a leading global specialty materials company that advances science for smarter outcomes. We partner with customers worldwide to deliver next‑generation materials for refrigeration, semiconductor manufacturing, data center cooling, nuclear power, protective fibers, healthcare packaging and more.