Specialist Manufacturing New Product Introduction (NPI) - Upstream

• Communicate and interface between GMP manufacturing teams and Process Development scientific groups
• Ensure new products are successfully introduced into ANC’s biologics manufacturing facility
• Host cross-functional meetings to drive timelines to support tech transfer
• Propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy
• Coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality to introduce new Drug Substance products and/or advanced technologies
• Lead or participate in projects ensuring production documents are accurate and up to date
• Support Manufacturing in troubleshooting, problem solving and RCAs
• Own New Product Introduction Change Controls and collaborate with stakeholders to drive on-time completion
• Respond to regulatory questions and/or audit findings
• Champion Lean Transformation and OE initiatives.

High school diploma / GED & 10 years of biotechnology operations experience OR Associate’s degree & 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in GMP manufacturing operations
• Strong technical knowledge of drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture, harvest)
• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical areas
• Background in lean manufacturing methodologies and operational excellence

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible.