Manufacturing Associate III (CDMO) - Arevna : Job Details

Biologics CDMO Hiring Opportunity

Position: Manufacturing Associate III

Location: San Antonio, Texas

Overview: We are seeking a talented Manufacturing Associate III to join our team in a biologics-focused Contract Development and Manufacturing Organization (CDMO). This position involves supporting cGMP manufacturing processes in a controlled cleanroom environment. The ideal candidate will have strict attention to detail, a commitment to quality, and the ability to collaborate within cross-functional teams.

Key Responsibilities:

• Execute and document batch records in compliance with current Good Documentation Practices (GDP).
• Revise and review Standard Operating Procedures (SOPs), batch records, and related documentation.
• Support upstream/downstream manufacturing processes, including microbial fermentation, mammalian cell culture, and purification techniques.
• Operate and maintain systems for microbial fermentation, mammalian single-use systems, continuous flow centrifuges, and homogenization.
• Perform tangential flow filtration (TFF), depth filtration, and chromatography (AKTA, HPLC systems).
• Conduct drug substance bulk fill, vial fill, and aseptic handling.
• Collaborate on deviation and CAPA resolution with Subject Matter Experts (SMEs) and quality teams.
• Support equipment calibration and preventative maintenance.
• Ensure adherence to safety policies and goals.

Education & Experience:

• Associate's, Bachelor's, or Master's degree in a Scientific or Engineering discipline.
• 3-4+ years of experience in biomanufacturing within a GMP environment.
• Experience with microbial systems is highly desirable.
• Strong knowledge of cGMP principles and Quality Management Systems.

Knowledge & Skills:

• Excellent verbal and written communication skills.
• Strong analytical ability and professional presence.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Project.
• Working knowledge of cGMPs and global regulatory requirements.
• Exceptional interpersonal skills and the ability to lead through influence.
• High-energy, results-oriented approach to problem-solving and teamwork.

Physical Requirements & Working Environment:

• Flexibility in working hours, including weekends and varying shifts.
• Ability to gown in cleanroom attire and stand for extended periods.
• Comfortable working in an environmentally controlled facility.
• Capability to lift and move up to 20 pounds as needed.

This is a great opportunity to contribute to a growing CDMO that prioritizes quality, speed, and flexibility. If you are passionate about biologics manufacturing and thrive in a dynamic environment, we'd love to hear from you!

How to Apply: Submit your application today to be considered for this exciting opportunity. Qualified candidates will be contacted for further steps.