Manufacturing Technical Specialist (Downstream)

• Develops and cultivates positive internal Avid group (MSAT, Facility, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships.
• Working with MFG Technical Supervisor/Manager in Overseeing and approving the BPR, Unicorn method, BOM, and buffer and solution planning as the manufacturing stakeholder.
• Working with MFG Technical Supervisor/Manager to identify and initiate process and procedural changes to improve performance, robustness, productivity, safety, efficiency, and compliance.
• Communicating with Client, MSAT, and QA on Process Status and collaborating to resolve technical issues on the floor.
• Maintaining and managing the equipment list and needs for all downstream processes. Collaborating with facility and MSAT to ensure successful and sufficient equipment allocations for all processes.
• Reviewing Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures.
• Leading technical training to Manufacturing Downstream Operators.
• Supporting MFG Technical Supervisor/Manager in CAPA (Corrective Action Preventive Action) investigations and recommending dispositions for the manufacturing team.
• Other tasks may be assigned as needed.
• B.S/M.S. in scientific or engineering (chemical or biomedical) discipline.
• 4+ years of Experience downstream MFG with B.S and 2+ years with M.S.
• Strong technical experience within relevant manufacturing process technologies and unit operations.

of commercial cGMP manufacturing.

• Technical expertise in Downstream processes such as depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
• Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software.
• Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.
• The ability to work effectively and lead small matrix and cross-functional teams in a fast-paced environment with changing priorities and a high level of urgency.