Manufacturing Representative - Weekend Shift

Key responsibilities

• Actively involved in the manufacturing of oligonucleotide APIs in a GMP environment.
• Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing.
• Write and revise standard operating procedures according to regulatory and procedural guidelines.
• Work with Validation and Engineering personnel to validate new equipment and facilities.
• Work with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.).
• Maintain, calibrate, and trouble shoot critical process equipment.

Qualifications

• BS in chemistry, biology, biochemistry, science or equivalent or equivalent combination of education and or experience preferred but not required
• 1+ years of related experience in a pharmaceutical manufacturing environment preferred but not required
• Previous knowledge of oligonucleotide synthesis, purification, UF, conjugation, and lyophilization is advantageous
• Detail oriented and can perform technical duties following standard operating procedures and general laboratory safety rules
• Able to perform mathematical calculations, document procedures, communicate effectively, and troubleshoot operational issues
• Mechanically inclined
• Able to work as a successful member of a team working to establish priorities, scheduling, and procedures that collectively will meet department goals and project deadlines
• Able to work in a clean room environment
• Previous experience in a FDA regulated manufacturing environment highly desired