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- Purify antibodies and develop labeling/conjugation processes.
- Supervise purification personnel and ensure cGMP compliance.
- Write/revise SOPs and oversee batch record accuracy.
REPORTS TO: This position reports to the Laboratory Manager at the Everett Bioprocessing facility
SCOPE OF RESPONSIBILITY: The person will be responsible for the purification of antibodies, column building, labeling of antibodies, and supervision of employees at the Everett Bioprocessing Facility
POSITION REQUIREMENTS:- Minimum of a Bachelor’s degree in a scientific field with a minimum of 3-5 years of practical experience
- Good oral and written communication skills (English) and mathematics skills are required.
- Windows-based computer skills, familiarity with Microsoft Word and Excel
- Good organizational skills with the ability to manage multiple priorities
- Experience with cGMP quality systems and manufacturing operations
- Ability to give directions, train others, and communicate effectively
POSITION OBJECTIVE: To purify normal, and secondary antibodies with the goal of providing consistent, high-quality products and services to our customers with complete, accurate documentation. To guide the department into new areas.
RESPONSIBILITIES INCLUDE (but are not limited to):- Column building of affinity columns for purification technicians
- Development of labeling processes of antibodies for production scale
- Development of Conjugation processes of antibodies for production scale
- Oversight of Protein A and Protein G purification of Normal IgGs and other antibodies
- Write and revise Standard Operating Procedures (SOPs) and Batch Records (BR) as needed
- Assist in filling, labeling, and finishing good inspection
- Oversee all purification personnel.
- Operate Basic Laboratory and Analytical equipment
- Compliance with all Standard Operating Procedures (SOPs) in relation to Protein Purification
- Perform work in accordance with current good manufacturing practices (cGMP)
- Assist in the preparation of investigation reports as part of the Corrective and Preventive Action (CAPA) program
