• Responsible within Global External Manufacturing to support the oversight of Contract Manufacturers of Biologics Drug Substances and Drug Products for commercial and clinical programs.
• Proactively and effectively work with other functions (Quality Assurance, Quality Control, Strategic Sourcing, Supply Chain, Regulatory, Portfolio Management) to execute on manufacturing strategy.
• Executes the regular, tactical management of CMOs to ensure products are manufactured in accordance with the registered process and approved Master Production Record
• Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
• Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.

• BS/BA in Science field with 10-15+ years of experience
• Top 3 Required Skill Sets: GMP Manufacturing expertise in commercial Biologics Drug Substance, Communication (written and verbal), Decision making (prioritization, risk evaluation)
• Top 3 Nice to Have Skill Sets: Drug Product expertise, Technology Transfers, Clinical product manufacturing
• “Highly impactful role contributing to the advancement of innovative and transformative therapies.
• Must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent.

Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)