Immunomedics, Inc.

  • Biopharmaceutical Manufacturing Manager (2nd Shift)

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(3/23/2018 10:44 AM)
    Job ID
    2018-1078
    # of Openings
    1
    Category
    Scientific Manufacturing/Production
  • Overview

    We are seeking a Biopharmaceutical Manufacturing Manager (2nd Shift) to supervise the team responsible for manufacturing of products in compliance with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs). 

     

    Primary schedule will run Monday through Friday between 6:00am-2:30pm or 1:30 pm-10:00 pm, though occasional variation to those hours may be required.  

    Responsibilities

    • Operates and leads automated protein purification process for large scale purification of monoclonal antibodies.
    • Purifies antibodies using ion-exchange, affinity column chromatography, and virus removal filtration.
    • 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 smoother.
    • Evaluates process performance.
    • Reviews and maintains accurate batch records, log books, and log sheets.
    • Writes/revises batch records, buffer sheets, SOPs, and Material Safety Sheets (MSSs)
    • Writes protocols and reports when necessary.
    • Creates and maintains new equipment inventory via change control process.
    • Supervises, trains, and mentors Manufacturing Technologists, and directs daily group activities.
    • Carries out direct supervisory responsibilities in accordance with the department-set goals

    *Training will take place on 1st shift until Immunomedics adds the 2nd shift.

    Qualifications

    • Bachelor’s degree in biology, chemistry, or related discipline, plus 5-10 years of industry experience in large scale protein purification with at least one year as a supervisor or manager, or equivalent combination of education and experience.
    • Proficiency with automated purification software (e.g. UNICORN) is desired.
    • Demonstrated ability to lead and influence others.
    • Ability to follow SOPs and cGMP guidelines and regulations.
    • Must possess excellent communication (oral and written) and interpersonal skills. 
    • Detail oriented with strong organizational, follow-through, and problem-solving skills.
    • Must be able to work collaboratively in a team environment. 
    • Must be proficient with MS Office applications

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