Downstream Manufacturing Lead - Biologics GMP Ops

Matica Biotechnology, Inc.; College Station (TX); On-site; USD 90,000 - 150,000; Full time

Job summary

Matica Biotechnology, Inc. is seeking a Manufacturing Downstream Lead to manage daily operations in a fast-paced cleanroom setting.

You will oversee purification, filtration, and filling activities, ensuring adherence to cGMP and regulatory requirements while coordinating product sample transfers to Quality Control. The role requires 3–4 years in manufacturing (4–5 without AS/BS), with strong knowledge of TFF, chromatography, and aseptic processes.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry, or equivalent.
• Min. 3-4 years of experience in manufacturing (Min. 4-5 years without AS/BS); GMP setting preferred, previous downstream experience preferred.
• Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Bioprocessing Operations.

Responsibilities

• Prioritize manufacturing schedule requirements and execute the daily schedule.
• Lead operations and act as the main point of contact within the cleanroom.
• Coordinate transfer of product samples to Quality Control.
• Read and understand technical documentation and execute instructions.
• Train junior manufacturing associates and support CAPA investigations.
• Involvement in equipment qualification and validation activities.
• Plan and maintain material inventory for manufacturing processes.
• Communicate issues clearly to management.

Skills

GMP knowledge

aseptic operations

leadership

documentation

Education

AS/BS in Biotechnology or related

Tools

Chromatography

TFF (Tangential Flow Filtration)

Filtration techniques

Job description

Matica Biotechnology, Inc. is seeking a Manufacturing Downstream Lead to manage daily operations in a fast-paced cleanroom setting.

You will oversee purification, filtration, and filling activities, ensuring adherence to cGMP and regulatory requirements while coordinating product sample transfers to Quality Control. The role requires 3–4 years in manufacturing (4–5 without AS/BS), with strong knowledge of TFF, chromatography, and aseptic processes.