Lead Specialist in Upstream Manufacturing

1 week ago

College Station, Texas, United States FUJIFILM Diosynth Biotechnologies Full time

At FUJIFILM Diosynth Biotechnologies, we recognize the significance of our work and are in search of skilled professionals to join our dynamic team. Our organization is expanding its facilities, enhancing its capabilities, and growing its workforce. We are eager to find passionate individuals who are committed to making a substantial impact in the field of biopharmaceuticals.

Located in a vibrant community, our site is a source of pride and innovation, providing an ideal environment for both families and individuals who appreciate the charm of a close-knit town while being in proximity to larger urban centers.

Position Overview: The Manufacturing Technician IV will engage with a variety of advanced technologies. This role offers a pathway for those interested in either deepening their technical expertise or pursuing supervisory responsibilities. Depending on the assignment, the technologies involved may include:

Upstream Processes:

  • Single-Use Cell Culture Vessels/Bioreactors up to 2000L
  • Bacterial Fermentation Culture Vessels up to 2000L
  • Continuous Flow Centrifuges
  • Disposable Mixing Systems
  • Cell Expansion and Propagation Techniques
  • Banking and Cryopreservation of Cell Lines and Viruses
  • Adherent Cell Technologies
  • Microscopic Examination and Plate Counting
  • Monitoring of Cultures, Sampling, and Sterilization Procedures

Key Responsibilities:

  • Draft and review standard operating procedures, buffer formulation records, and batch production documentation.
  • Support senior personnel in executing safety and quality assurance initiatives in line with established protocols.
  • Ensure confidentiality of proprietary information.
  • Maintain accurate records of activities in compliance with cGMP regulations and oversee the training of junior staff.
  • Operate various production equipment, including autoclaves, incubators, and analytical instruments.
  • Perform additional tasks as required.

Technician IV - Supervisory Pathway:

  • Effectively manage multiple projects simultaneously.

Required Skills & Qualifications:

  • Strong verbal and written communication skills, along with excellent organizational abilities.
  • Proficiency in Microsoft Office Suite.
  • Demonstrated leadership capabilities.
  • Ability to mentor others in adhering to cGMP standards.
  • Attention to detail and self-discipline.
  • Flexibility to work varied shifts, including weekends and nights, as necessary.
  • Solid mathematical and computer skills.
  • Experience in a cleanroom environment with aseptic techniques.
  • Effective planning and time management skills, with the ability to collaborate across various roles.

Working Environment & Physical Demands:

The physical requirements outlined here are typical for employees in this role. Reasonable accommodations may be made for individuals with disabilities. While performing the duties of this position, employees are frequently required to:

  • Stand for extended periods, bend, stoop, push, pull, and reach overhead.
  • Utilize hand-eye coordination and manual dexterity for operating office equipment.
  • Handle potential exposure to hazardous materials.
  • Wear personal protective equipment as necessary.
  • Lift and move items weighing up to 50 pounds occasionally.
  • Maintain consistent attendance.

Minimum Qualifications for Technician IV:

  • Bachelor's degree in a relevant scientific field with 2 years of experience; OR
  • Associate's degree with 4 years of relevant experience; OR
  • High School diploma/GED with 6 years of relevant experience.

FUJIFILM Diosynth Biotechnologies is committed to advancing the future of medicine and empowering our employees to pursue their potential. We strive to foster a culture of innovation and excellence.

We are an equal opportunity employer and value diversity in our workforce. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status, or any other characteristic protected by applicable law.

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