Downstream Manufacturing Associate III

Velocity Bioworks•San Antonio, TX

3d•Onsite

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

Associate’s, BS, or MS from an accredited college or university with major coursework in a Scientific- or Engineering-related discipline preferred.

Responsibilities

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.
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.
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.
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.