Manufacturing Technician

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