Downstream Manufacturing Associate III

Description

TITLE: Downstream Manufacturing Associate III

REPORTS TO: Downstream Supervisor, Manufacturing

LOCATION: San Antonio, Texas (On-site)

The Company

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.

Position Summary

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 escalate issues appropriately, and the ability to work well and collaborate in cross-functional teams at Velocity Bioworks .

Key Responsibilities

Manufacturing Operations

• Execute and document batch records in compliance with GDP.
• Support daily manufacturing for clinical and commercial programs.
• Microbial fermentation and/or mammalian cell culture knowledge 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 Unicorn methods.
• Use pH/conductivity meters, balances, welders, sealers, etc. 
• Safely handle utility units.
• Manual filtrations, and integrity testing 
• Solution preparation 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 preventative maintenance programs.
• Support deviation/investigation, CAPA resolution, and change control implementations.
• Maintain client and company confidentiality.
• 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 the equipment.

Requirements

Education and Experience

Shall have education, training, and experience, or any combination thereof.

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

Knowledge and Skills

• Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
• Critical and analytical thinking, analytical ability, good judgment, ethics, professional presence, interdepartmental collaboration, and demeanor are traits of successful manufacturing technicians.
• Must demonstrate proper writing and PC skills with a knowledge base in Microsoft Office Suite.
• Must maintain a working knowledge of commercial CGMP’s and phase-appropriate CGMP’s as they apply to various phases of clinical and commercial manufacturing.
• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies. 
• Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

Physical Requirements and Working Environment

• Must be able to stand for extended periods and lift up to 20 lbs.
• Must meet gowning requirements for cleanroom Grade A/ISO 5 environments and pass PAPR physical requirements.
• Requires flexibility with work hours, including weekends or adjusted shifts.
• Work performed in both office and cleanroom/lab settings with moderate noise levels.
• Requires manual dexterity, vision acuity, and computer use.

Notice to Third Party Agencies: Velocity Bioworks does not accept unsolicited resumes from recruiters or employment agencies. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement and approved engagement request with Velocity Bioworks, Velocity Bioworks reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Velocity Bioworks is proud to be an EEO/AAP Employer. Velocity Bioworks encourages protected veterans, individuals with disabilities, and applicants from all backgrounds to apply. Velocity Bioworks ensures nondiscrimination in all programs and activities in accordance with Title VI of the Civil Rights Act.