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Manufacturing Technician

3 months ago

College Station, United States BioPharma Consulting JAD Group Full time
Job DescriptionJob Description

Summary: BioPharma Consulting JAD Group is currently seeking a Manufacturing Technician to join our team. The Manufacturing Technician will work directly with a range of technologies (Upstream, Downstream or Buffer Preparation Unit Operations ) In this role, you will be responsible for performing manufacturing processes according to Standard Operating Procedures (SOP) in a GMP manufacturing environment.
Functions:

  • Upstream Unit:
    • Single-Use Cell Culture Vessels/Bioreactors up to 2000L
    • Bacterial Fermentation Culture Vessels up to 2000L
    • Alpha Wasserman Continuous Flow Centrifuge
    • Disposable Magnetic Mixing Bags and Totes
    • Cell Expansion and Propagation
    • Banking/Cryopreservation of Cell Lines and Viruses
    • Hyperstack, Cellstack, and other Adherent Cell Technologies
    • Plate counting, microscopic examination
    • Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
  • Downstream Unit:
    • Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF),
    • Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration
    • Medium to Large-scale Chromatographic systems (ÄKTA).
    • Pre-Packed Columns from 1L to 100L
    • Single use mixing systems (Pall & GE)
    • Single Use connectivity types such as GE DAC and Colder AseptiQuik
    • Bulk filling • Aseptic process simulation and drug product filling
  • Buffer Preparation Unit:
    • Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs
    • Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
    • Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
    • Integrity testing of filters

Essential Functions Include:

  • Write and review standard operating procedures, buffer formulation records and batch production records.
  • Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
  • Maintain the confidentiality of proprietary company information.
  • Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
  • Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
  • Perform daily cleaning and sanitization of the laboratory and manufacturing areas.
  • Maintain an effective working relationship with others.
  • Perform all other duties as assigned.

Required Skills & Abilities:

  • Excellent oral and written communication skills, interpersonal and organizational skills.
  • Proficient with Microsoft Office applications.
  • Ability to train others to perform to cGMP standards.
  • Good self-discipline and attention to detail.
  • Excellent math and computer skills.
  • Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
  • Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.

Requirements

Qualification:

  • Master’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with three (3) years of relevant experience OR
  • Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with one to five (1-5) year of relevant manufacturing experience in GMP or regulated industry; OR
  • Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field and two to seven (2-7) years of relevant experience; OR
  • High School/GED with four to nine (4-9) years of relevant experience.

Requirements:

  • Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.
  • Must be able to work alternative shift hours to include night shift hours and weekends as required.

Preferred Qualifications:

  • GMP experience
  • Green-Belt Certification
  • Biotechnology certificate preferred.
  • Cross training with other identified functional areas
  • Experience with mammalian, insect, yeast, or bacterial cell lines and their cultivation and/or purification of biologics or viral vectors produced