Responsibilities will include, but are not limited to, the following:
• Support cGMP contract manufacturing activities for Celgene’s late stage development and commercial drug substances (API) including small molecules, oligonucleotides, and peptides,in order to meet quality specifications and inventory goals.
• Work with a team of chemists, engineers and analytical scientists to to apply engineering and chemical principles to improve and successfully scale-up synthesis and purification processes for the wide variety of drug substances listed above..
• The position entails both domestic and international travel (up to 20%) to Celgene’s internal and contract manufacturing facilities.
• Act as a liaison between Celgene and contract manufacturing organizations for the manufacturing of late stage development and commercial APIs.
• Work closely with Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain Planning groups for the management of manufacturing schedules, resolution of technical issues,batch record review and batch release/disposition activities.
• Responsible for the collection of manufacturing data to monitor trends and drive continuous process improvement.
• Management of technical projects including experiments supporting commercialization efforts, process validation and support of regulatory filings.

Skills/Knowledge Required:
• BS or MS degree in chemical engineering, chemistry, biochemistry or biology.
• At least 5 years’ experience in the chemical/pharmaceutical and/or biotechnology industry.
• 2-3 years’ experience working for chemical/pharmaceutical manufacturing/process development organizations in a cGMP environment or working with cGMP contract manufacturing organizations.
• Experience with bulk chemicals manufacturing and/or commercial API manufacturing. Candidates should have a working knowledge of or experience with small molecule synthesis purification techniques, and analytical methodology. Prior practical experience with solid phase synthesis of oligonucleotides or peptides would be beneficial.
• Focused on delivering excellent results and improving the performance of technical projects.
• Recognizes opportunities and/or issues and applies analytical and creative thinking to maximize performance
• Capable of handling multiple tasks/projects.
• Experience with management of contract manufacturing organizations and technology transfer.
• Excellent supervisory, organizational and interpersonal skills.
• Ability to communicate effectively in a diverse team environment.
• Well versed in cGMP regulations and/or possess experience with process validation and project management.

Qualifications
Solid background in API process development and technology transfer and/or commercial manufacturing
Minimum of 5 years experience in cGMP API and/or DP manufacturing.
Display a strong focus on quality, technical detail and results.
BS or MS degree in chemical engineering, chemistry, biochemistry or biology.