Upstream Manufacturing Lead

Position Overview

The Manufacturing Technician IV will work directly with a range of technologies.

The Technician IV level provides an opportunity to stay on the technical track or work towards a supervisory path.

Dependent upon assignment, the range of technologies may include any of the following :

Job Description

Upstream Unit :

Single-Use Cell Culture Vessels / Bioreactors up to 2000L

Bacterial Fermentation Culture Vessels up to 2000L

Alpha Wasserman Continuous Flow Centrifuges

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

Plate counting, microscopic examination

Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

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 all other duties as assigned.

Technician IV Minimum Qualifications :

Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; OR

Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; OR

High School / GED with 6 years of relevant experience.

Join us!

FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.

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