Manager Protein Purification

Immunomedics, Inc. Morris Plains , NJ 07950

Posted 5 days ago

Overview

Responsible for downstream manufacturing(purification) in compliance with cGMPs and SOPs and supervises Manufacturing Technologists.

Responsibilities

  • 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 technologists under his supervision 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.

  • 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.

  • Must be proficient with MS Office applications.

  • Familiarity with cGMP regulations and practices.

  • Must possess strong leadership skills.

Qualifications

  • Bachelor's degree in biology, chemistry, or related field, with at least 5-7 years of related experience; or equivalent combination of education and experience. Master's degree preferred.

  • Familiarity working in a bioburden controlled setting required.

  • Hands-on experience with protein purification preferred.

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VIEW JOBS 1/10/2019 12:00:00 AM 2019-04-10T00:00 Overview Responsible for downstream manufacturing(purification) in compliance with cGMPs and SOPs and supervises Manufacturing Technologists. This is a 2nd shift position (Hours: 1:30pm-10:00pm) Responsibilities * 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 technologists under his supervision 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 supervisory responsibilities in accordance with the department-set goals. * Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution. Qualifications * Bachelor's degree in biology, chemistry, or related field, with at least 5-7 years of related experience; or equivalent combination of education and experience. Master's degree preferred. * Familiarity working in a bioburden controlled setting required. * Hands-on experience with protein purification preferred. Immunomedics, Inc. Morris Plains NJ

Manager Protein Purification

Immunomedics, Inc.