Protein Purification Manager

Job Location
Beverly, MA
Job Description


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.



3-5 years of related life sciences experience or equivalent combination of education and experience.
Experience with AKTA Pilot and Production Systems required.
Demonstrated process development, scale-up, and scale down experience.
Previous management/supervisory experience.
Excellent oral and written communication skills.
Previous experience in ISO/GMP environment 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.
The 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.
Must be able to apply knowledge of Current Good Manufacturing Practices (cGMPs) on a daily basis.
Must be able to lift up to 50 lbs.


Bachelor’s degree from four year college or university or equivalent combination of training and experience.

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