Downstream Manufacturing Associate III

Downstream Manufacturing Associate III

Reports To:

Downstream Supervisor, Manufacturing

Location:

San Antonio, Texas (On-site)

Velocity Bioworks is a U.S.

-based biopharma CDMO headquartered in San Antonio, Texas supporting funded programs as they move from development into manufacturing for clinical trials. We collaborate with sponsors who are past exploration and are ready to apply discipline, structure, and technical rigor to development, analytics, and manufacturing. Velocity is built to accelerate speed to clinic through aligned execution. Our work focuses on translating defined program goals into scalable manufacturing processes and robust analytical strategies.

These activities are designed to support near‑term clinical timelines while meeting quality requirements. We operate where quality and execution directly influence clinical and business progress.

Reporting directly to the Downstream Supervisor, the Downstream Manufacturing Associate III will be responsible for overseeing daily operations related to downstream processing in a CGMP‑compliant biologics environment. An ideal candidate must have strong experience in downstream manufacturing, process execution, and the operation of qualified manufacturing equipment. Strong understanding of Good Manufacturing Practices (CGMP) and regulatory guidelines, strict attention to detail, high‑quality customer service skills, sound judgment, and ability to collaborate in cross‑functional teams at Velocity Bioworks are required.

• Manufacturing Operations
  • Execute and document batch records in compliance with GDP.
  • Support daily manufacturing for clinical and commercial programs.
  • Perform microbial fermentation and/or mammalian cell culture as required.
  • Perform drug substance bulk fill or vial fill using aseptic techniques.
  • Operate autoclave systems and manage sample handling.
  • Support and execute routine cleanroom cleaning activities.
• Downstream Processing
  • Operate bench to large‑scale chromatographic systems.
  • Operate bench to large‑scale filtration systems (TFF, depth, and sterilizing‑grade filtration).
  • Pack and evaluate chromatography columns.
  • Author and review manufacturing methods.
  • Use pH/conductivity meters, balances, welders, sealers, etc.
  • Safely handle utility units.
  • Perform manual filtrations and integrity testing.
  • Prepare solutions using jacketed and non‑jacketed mixing units.
• Documentation and Compliance
  • Author, revise, and review SOPs, work instructions, forms, and batch records.
  • Ensure adherence to equipment calibration and preventive maintenance programs.
  • Support deviation/investigation, CAPA resolution, and change control implementations.
  • Maintain client and company confidentiality.
• Shift Execution
  • Oversee execution of shift activities to ensure alignment with the established manufacturing schedule.
• Cross‑Functional Collaboration
  • Provide input and feedback to the Process Sciences/Technical Transfer team during development, scale‑up, and transfer.
  • Adhere to and promote safety policies across teams.
  • Interact with external vendors or suppliers.
  • Review bill of materials and technical transfer collaboration documents.
  • Support facilities and equipment validation in ensuring proper functionality of equipment.

• Associate’s, BS, or MS from an accredited college or university with major coursework in a scientific or engineering discipline preferred.
• Experience working in a GMP manufacturing environment is essential.
• Manufacturing processes in microbial and mammalian production systems are required.
• Requires 5+ years of biomanufacturing experience for AS/BS or 3+ years for MS.
• Requires a strong background in CGMP principles and Quality Management Systems.

• Excellent verbal and written communication skills; strong presentation skills.
• Critical and analytical thinking, good judgment, ethics, professional presence, interdepartmental collaboration, and demeanor are important.
• Proficient with Microsoft Office Suite and PC skills.
• Maintain working knowledge of commercial CGMPs and phase‑appropriate CGMPs in all phases of clinical and commercial manufacturing.
• Current global regulatory requirements…