Downstream Supervisor, Manufacturing

TITLE: Downstream Supervisor

REPORTS TO: Manager, 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 Manufacturing Manager, the Downstream Supervisor 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 scaled 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

Supervisory Role in Manufacturing Operations

• Responsible for supervising daily manufacturing activities.
• Responsible for setting manufacturing schedules and timelines and ensure adherence by manufacturing team.
• Responsible for authoring and reviewing batch records and other CGMP documentation.
• Accountable for time and resources management. Managing shift operations, prioritizing tasks, strategic resources allocation, delegating tasks effectively to assure schedule adherence.
• Capable of motivating, coaching, and leading a team in a fast-paced, regulated environment. Leads by example, especially regarding GMP compliance and safety.
• Responsible for hiring, onboarding, training, and performance evaluations.
• Ensure team execution is logged in Net Suite program.
• Ensure manufacturing execution is in compliance with equipment calibration and preventive maintenance.
• Responsible for implementing continuous improvement methodologies. Encourages team suggestions for process improvement and error reduction.

Downstream Processing Expertise

• Operate bench-scale to large-scale chromatography (AKTA) systems.
• Operate bench-scale to large-scale filtration systems including tangential flow filtration (TFF) and depth filtration (DF).
• Expert in Unicorn software for programming and control of chromatography (AKTA Pilot and AKTA Ready) and filtration (AKTA Ready Flux) systems.
• Large-scale column packing and evaluation.
• Single-use mixing and centrifugation systems (continuous and bucket)
• Bulk fill and aseptic handling techniques
• Filter use, handling, and filter integrity testing (FIT) with troubleshooting experience
• Drive proactive troubleshooting among staff, encouraging equipment and processes SMEs development.

Documentation and Compliance

• Maintain company and client confidentiality.
• Responsible for meticulous and accurate review of executed production records for proper GDP and execution of production activities within established timelines.
• Active collaboration with Change Controls, Risk Assessments, and Deviations Management, Investigation Tools (5 Why's, Fishbone Diagram, etc.) and CAPA Implementation in association with SMEs and QA team.
• Communicate safety policies and goals and ensure team members adhere to facility safety policies.
• Ability to track and interpret manufacturing performance data and use metrics to drive improvements.

Cross-functional Collaboration

• Provide input and feedback to the Process Sciences/Technical Transfer team during development and scale-up.
• Ability to coordinate activities with QA, QC, Process Sciences, Facilities, GMP Services, and Supply Chain teams.

Requirements

Education and Experience

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

• Associate's, BS, MS, Ph.D. from an accredited college or university with major coursework in a Scientific or Engineering discipline preferred.
• Ph.D. with 0-2 years, Master's with 4+ years, Bachelor's Degree with 6+ years or Associate's with 8+ years of experience within related discipline and track record of success.
• Experience working in a GMP manufacturing environment is essential.
• Manufacturing processes in downstream microbial systems is highly desirable.
• Requires a strong background in CGMP and GDP principles and experience handling Quality Management Systems.

Knowledge and Skills

• Must demonstrate proper writing and PC skills with a knowledge base in Microsoft Office Suite.
• Must obtain a working knowledge of current global regulatory requirements and…