- Location: Pottstown, PA
- Type: Direct Hire
- Job #34219
The Protein Purification Manager is responsible for operating and optimizing 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.
– Utilize AKTA column chromatography for production.
– In-depth understanding of automated systems is required.
– Ability to execute Manufacturing purification protocols.
– Supervise and assign duties to Technicians engaged in purifications.
– Responsible for training and assessment of direct reports.
– Distribute production schedules/work orders.
– Demonstrated Column packing and evaluation skills.
– Technical training and assessment of new and existing staff.
– 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.
– Departmental representation and ability to lead/participate in cross-functional teams including Process Development, Quality Assurance and Quality Control, Maintenance, Validation, Materials and Logistics and Regulatory teams is required.
– In-depth knowledge of quality systems, validation principles, regulatory guidelines and multi-product controls required.
– Demonstrates strong computer, organizational, and project management skills.
– Demonstrates ability to recognize deviation from accepted practice.
– Demonstrates an ability to communicate effectively with peers in organization.
– Ability to work independently with minimal supervision, in teams, proactive and self-managing, proven problem solving as well as a detailed and organized approach are key requirements.
– Writes, maintains and/or implements changes to controlled documents (e. g., SOPs, Specifications, Methods, etc.) as needed.
– Maintain/evaluate WIP inventory and materials required for production.
– Supervise 2-6 employees.
– Additional duties as assigned.
– 2+ years of people management/supervisory experience required.
– 5 years of Purification experience required.
– Experience with AKTA systems.
– Demonstrated process development, scale-up, and scale down experience.
– Excellent oral and written communication skills.
– Demonstrated Scientific problem solving skills.
– Positive external and internal relationship management skills.
– Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company.
- Bachelor’s degree