Immunomedics, Inc.

  • Manager, Downstream Manufacturing (Rotating Shift)

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(4/3/2019 12:09 PM)
    Job ID
    2019-1420
    # of Openings
    2
    Category
    Scientific Manufacturing/Production
  • Overview

    Responsible for downstream manufacturing (purification) in compliance with cGMPs and SOPs and manages a team within the Manufacturing department.

    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 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.

    Qualifications

    • 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.  
    • Must be proficient with MS Office applications. 
    • Familiarity with cGMP regulations and practices. 
    • Must possess strong leadership skills. 

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