Downstream Process Sr. Manager

Process Development, scale up and manufacturing of proteins.
Downstream processing of in house and contract projects.
Plan daily manufacturing activities and troubleshooting.
Will Manage a midsize team.
Planning of raw material /consumables management for production campaign.
Drive the qualification activities for all downstream equipments.
Follow cGMP practices during the manufacturing activity and operations associated activities with QA and QC.
Coordination with inter-depts.
for closure of documentation and timely execution and contribution for the assigned tasks.
Handle client / regulatory audits and address queries related to manufacturing operations.
Recruit, train and manage the people.
Required Skills.
Chromatography systems at small scale and large scale (IEX, Affinity, HIC etc).
Production documents like BMR, MBR, Process validation, process fit risk analysis report,.
cleaning validation report, scale up study report etc Should be well versed with FPLC, AKTAProcess, AKTAPilot.
Sound knowledge on microbial expression system and their use in recombinant protein production.