Manufactures clinical and commercial biologics meeting the regulatory requirements of both domestic and international markets
Qualified in Production Technician II duties.
Experts and Qualified Trainers in the operation of production equipment in multiple areas in a large scale, automated bioprocess plant such as, bioreactors, centrifuges, virus filtration, depth filtration, tangential flow filtration, chromatography equipment, washers, autoclaves, biological safety cabinets, chemical fume hoods, column packing equipment, and instrumentation pH, conductivity, osmolality, blood gas analyzers, turbidity, etc.
Accurately analyzes and processes scientific data
Serves as the "Subject Matter Expert" in unit operation
Reviews Master Production Records for accuracy and completion of process steps, as requested
Authors and edits Standard Operating Procedures (SOPs), Master Production Records and Solution Preparation Records
Responsible for training junior staff
Mentors others in process operations and domestic and international regulatory compliance
Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff
Troubleshoots problems and recommends potential solutions to Manufacturing support groups and/or Management
Contributes to the development of new concepts and techniques
Leads unit operations or projects, as requested
Participates in the tech transfer process of new products into the manufacturing area.
May be cross-trained in multiple areas within Manufacturing
Identifies and supports the implementation of process efficiencies and areas for improvement
Advanced equipment knowledge to perform first line trouble shooting and root cause analysis
Advanced understanding of the general and detailed aspects of the job, and their practical applications to problems and situations commonly encountered
Advanced knowledge of how to effectively utilize MedI's enterprise systems such as:
o Microsoft Office
o Rockwell Process Control Systems (PCS)
Advanced knowledge of cGMP principals and standards
Sufficient knowledge of process, systems and equipment to troubleshoot problems
Demonstrates sound scientific knowledge and understanding of manufacturing processes in core area
Knowledgeable of electronic quality systems
Knowledgeable of the current Code of Federal Regulations (CFR)
* Preferred: Bachelors degree in the sciences or engineering and 3-5 years relevant experience
MedImmune - 17 months ago
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...