Responsible for downstream manufacturing (purification) in compliance with cGMPs and SOPs and manages a team within the Manufacturing department.
Leads the second shift operation of downstream manufacturing to purify the MAB (Immu-132) and package for shipment for processing into final product.
Ensures all Manufacturing Specialists under their leadership are fully trained both in cGMPs and their technical responsibilities
Confirms inventory of raw materials and supplies needed in manufacturing are staged per the schedule.
Purifies Immu-132 using ion-exchange and affinity column chromatography and virus removal filtration.
Ensures batch records are completed accurately and in a timely fashion.
Makes sure required samples are collected and delivered to QC for testing.
Works with other departments such as Quality Assurance and Compliance, Quality Control, Regulatory Affairs, Process Development, and Cell Culture Production to make the manufacturing process more compliant and more efficient.
Initiates deviations and conducts investigations as required.
Maintains and reviews log books for accuracy.
Writes and revises batch records, buffer sheets, SOPs, and MSSs as needed.
Confirms that daily and periodic maintenance and calibration of all equipment needed during production is complete.
Monitors schedule and assures adequate supply of buffers and production aids for manufacturing.
Carries out direct managerial responsibilities in accordance with the department-set goals.
Carries out direct managerial responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training, coaching and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.
Bachelor’s degree in biology, chemistry, or related field, with at least 8+ years of related experience; at least 3+ years managing direct reports; or equivalent combination of education and experience. Master’s degree is preferred.
Familiarity working in a bioburden controlled setting required.
Hands-on experience with protein purification preferred.
Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment.
Detail oriented with strong bioburden control techniques and understanding.
The ability to lead technical people and follow SOPs.