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MedImmune, LLC 113 reviews– Frederick, MD
BioSpace - 30+ days ago
* Daily supervising and performing on-the-floor operations pertaining to biologics manufacture in a cGMP environment
* Coaching, counseling, training/development, discipline and recognition of direct staff, including performing annual performance reviews
* Generating SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture.
* Executing production and resource schedule against operational plan
* Ensuring performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support)
* Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements
* Final review of completed manufacturing documentation per compliance standards and established timelines
* Investigating and resolving problems, identifying root cause, and proposing process improvements through clear communication to senior management
* Interacting with outside vendors and senior management
* Participation and/or leadership role in multi-functional project teams, as necessary
* Participate in helping to evaluate and establish potential new interdepartmental procedures and practices
* Other duties as assigned or identified
Candidates must be open to working a night shift schedule.