Manufacturing Downstream Lead

Matica Biotechnology•College Station, TX

21h

About The Position

The Manufacturing Downstream Lead prioritizes manufacturing schedule requirements and executes the daily schedule communicated by the Manufacturing Manager in a fast-paced manufacturing operation. The role leads operations and serves as the main point of contact in the cleanroom, with work involving cell expansion, bioreactor operations, depth filtration, tangential flow filtration (TFF), chromatography, other filtration techniques, product transfer and sampling, and manual, semi-automated, or automated product filling. The Lead coordinates product-sample transfers and handovers to Quality Control; reads and executes technical documentation; applies cGMP principles and aseptic practices; troubleshoots processes; trains junior manufacturing associates; supports root-cause investigations and CAPA implementation; and participates in equipment and instrument qualification and validation. The role also plans and maintains manufacturing materials and inventory, keeps cleanrooms organized and audit-ready, communicates issues across departments, maintains training readiness, and completes administrative and technical-writing tasks as needed.

Requirements

Associate or bachelor's degree in biotechnology, biology, chemistry, or an equivalent field; a high school diploma or equivalent may be considered with relevant experience.
Three to four years of manufacturing experience; four to five years without an associate or bachelor's degree.
Advanced knowledge of GMP, FDA, and EMA regulatory requirements applicable to biologics, including gene and viral therapy products, with a focus on bioprocessing operations.
Advanced knowledge of manufacturing processes and understanding of, or ability to use, current technologies.
Knowledge of aseptic practices and cleanroom operations.
Logical and sound decision-making, critical-thinking, and problem-solving abilities.
Computer software, organization, 5S, record-keeping, planning, time-management, and multiple-project support or leadership skills.
Leadership, diplomacy, written and oral communication, teamwork, independent work, and strong work ethic.
Ability to work nights, weekends, and holidays, and across schedules that may include Monday through Friday, alternating days, and 8-, 10-, or 12-hour shifts.

Nice To Haves

A science-related field of study.
GMP-setting experience.
Previous downstream manufacturing experience.
Basic lean skills.

Responsibilities

Prioritize manufacturing schedule requirements and execute the daily schedule communicated by the Manufacturing Manager.
Lead operations and serve as the main point of contact within the cleanroom.
Execute production activities including cell expansion, bioreactor operations, depth filtration, TFF, chromatography, other filtration techniques, product transfer and sampling, and product filling.
Coordinate product-related sample transfers and ensure proper handover to the Quality Control department.
Read and understand technical documentation and execute written instructions.
Apply cGMP principles and aseptic practices in manufacturing operations.
Troubleshoot processes and perform operations in an aseptic environment, biological safety cabinet, or isolator.
Train junior-level manufacturing associates.
Support root-cause investigations and implementation of corrective and preventive actions (CAPA).
Participate in equipment and instrument qualification and validation activities.
Plan, organize, and maintain material inventory; ensure materials are kitted for upcoming cleanroom operations.
Keep cleanrooms cleaned, organized, maintained, and audit-ready.
Maintain an up-to-date individual training plan and training profile.
Communicate problems and observations to manufacturing management and managers from other departments.
Attend meetings, send and receive emails, and participate in continuous improvement projects.
When necessary, prepare or contribute to technical documents such as deviation initiations, work-order requests, SOPs, logbooks, work instructions, and forms.
Perform other duties as assigned.