Drug Substance Manufacturing Associate

Biotechnology Manufacturing Associate

This employee will be responsible for the manufacturing of biotechnology products for clinical and commercial human use. The role requires the use of aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Compliance with company policies, procedures (SOPs), FDA current Good Manufacturing Practices (cGMP), and other applicable government regulations is mandatory.

Essential Duties & Responsibilities

• Participate in daily operations, including:
  • Weighing and dispensing of materials
  • Filtration systems
  • Inoculation of mammalian or cytokine cells
  • Fermentation and harvest processes
  • Chromatography columns and TFF operations
• Perform in-process testing, such as:
  • pH, Conductivity, Spectrophotometer, Osmometer, Cell count, etc.
• Prepare media and buffer solutions.
• Accurately complete Batch Records and other cGMP documentation in a timely manner.
• Remove and dispose of soiled materials from the manufacturing area.
• Ensure manufacturing areas are maintained under required clean room conditions.
• Report any nonconformances or events that arise during the shift to the Supervisor.
• Assist in the transfer of technology from Process Development to cGMP Manufacturing.
• Comply with all safety, cGMP, and company policies, practices, and procedures.
• Perform other duties as required or assigned.

Requirements

Education:

• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field preferred.
• Equivalent of 1+ years of experience in the biologics and/or pharmaceutical industry required.

For California Applicants:

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.