Industry: Biopharmaceuticals  
 
Job Description: 

• Responsible within Global External Manufacturing to support the oversight of Client’s 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 Client’s 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.  

Qualification: 

• Required Years of Experience: 15+ 
• Required Degree or Certification 4 year college (BS/BA in Science field) 
• Candidate must be flexible with work hours to support global network, either early morning (7 am) or evening (6pm) calls are frequent. 

Must Haves: 

• GMP Manufacturing expertise in commercial Biologics Drug Substance
• Communication (written and verbal)
• Decision making (prioritization, risk evaluation) 

Preferred Skills: 

• Drug Product expertise
• Technology Transfers
• Clinical product manufacturing

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)