The Protein Purification Manager will be responsible for the supervision and execution of protein purifications by assessing completeness, accuracy, and conformance to standards and specifications.
Job performance will involve a variety of activities including:
Utilize AKTA column chromatography for production.
Execute Manufacturing purification protocols.
Supervise (1-4 employees), train and assign duties to Technicians engaged in purifications.
Distribute production schedules/work orders.
Operate and optimize operations of chromatography columns as well as all related equipment and systems necessary to clean, configure, sanitize/sterilize and maintain equipment. In-depth knowledge of equipment is required.
Demonstrated Column packing and evaluation skills.
Expected duties include the optimization of safe and efficient operation of area processes. When appropriate, timely communication of deviations, incidents and/or safety concerns.
Project based tasks to aid in increasing efficiency, reliability, cost savings and overall department/site improvements are expected.
In-depth understanding of automated systems is required.
Departmental representation and ability to lead/participate in cross-functional teams including Process Development, Quality Assurance and Control, Maintenance, Validation, Materials and Logistics and CMC/Regulatory teams is required.
In-depth knowledge of quality systems, validation principles, regulatory guidelines and multi-product controls required.
Ownership of all Non Conformance, Deviations and CAPAs within the Manufacturing department.
Maintain/evaluate WIP inventory and materials required for production.
Writes, maintains and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Additional duties as assigned.