Downstream Manufacturing Technician II

FUJIFILM Diosynth Biotechnologies; College Station (TX); On-site; USD 40,000 - 80,000; Full time

Job summary

An innovative biopharma company is seeking a Downstream Manufacturing Technician II to join their dynamic team in College Station, Texas. This role involves working with advanced filtration and chromatographic systems, contributing to the production of life-saving therapies. Ideal candidates will possess strong communication and leadership skills, along with a background in biology or chemistry. If you are passionate about making a difference in healthcare and eager to work in a collaborative environment, this opportunity is perfect for you. Join us and help shape the future of biopharmaceuticals!

Qualifications

• 1 year relevant experience in a related field or 2 years with a High School/GED.
• Ability to train others to perform to cGMP standards.

Responsibilities

• Write and review operating procedures and production records.
• Document and maintain records according to cGMP regulations.
• Perform daily cleaning and sanitization of laboratory areas.

Skills

Excellent oral and written communication skills

Proficient with Microsoft Office applications

Excellent leadership skills

Attention to detail

Experience in cleanroom environment

Good planning and time management skills

Education

Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field

High School/GED with 2 years relevant experience

Tools

Autoclaves

Glass washers

Incubators

Analytical Scales

pH/conductivity meters

Job description

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The Manufacturing Technician II works directly with a range of technologies.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki.

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Job Description

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

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

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.
• Excellent leadership skills.
• Ability to train others to perform to cGMP standards.
• Good self-discipline and attention to detail.
• Must be able to work flexible hours, including outside of normal scheduled hours and weekends as necessary.
• Excellent math and computer skills.
• Experience working in a cleanroom environment with full gowning and aseptic technique.
• Good planning and time management skills, with ability to interface across roles and functions.

Working Conditions & Physical Requirements:

The physical demands include prolonged standing, bending, reaching, and lifting up to 50 pounds. Must wear PPE and attend regularly. Reasonable accommodations available for disabilities.

Minimum Qualifications:

• Associate’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field, with 1 year relevant experience; OR
• High School/GED with 2 years relevant experience.

Preferred Qualifications:

• Experience in a GMP environment
• Biotechnology Certificate

EEO & ADA Statements

Fujifilm promotes equal opportunity and provides accommodations for applicants with disabilities. Contact HR at [e-mail] or [phone] for assistance.