Manufacturing Downstream Lead

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 is a viral vector and gene therapy Contract Development and Manufacturing Organization (CDMO) that leverages advanced technologies at its purpose-built cGMP facility in College Station, Texas.

With industry-leading expertise in process development, assay development, and cGMP manufacturing, Matica Bio serves as a trusted partner, seamlessly supporting its clients with streamlined operations throughout every stage of virus-based projects. Collaborating across five Matica sites worldwide, Matica Bio delivers excellence in the CDMO domain through innovations such as MatiMax™ proprietary cell lines, in-line process monitoring, and single-use technologies.

The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a CDMO powered by people. Come join our dedicated team and Make it Happen With Matica Bio!

Manufacturing Downstream Lead

• Responsible for prioritizing manufacturing schedule requirements and executing the daily manufacturing schedule communicated by the Manufacturing Manager within a fast-paced manufacturing operation with primary activities including but not limited to Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.
• Lead operations and act as the main point of contact within the cleanroom.
• Coordinate the transfer of all products related samples and assure the proper handover of samples to Quality Control department.
• Read and understand technical documentation and execute written instructions.
• Possess an advanced understanding and ability to put into practice cGMP principles.
• Possess advanced operational skills, troubleshooting skills and process advanced knowledge within an aseptic environment, biological safety cabinet or isolator to execute such processes as Filling, filtration, product transfer, product sampling, chromatography, and TFF (Tangential flow filtration).
• Possess the ability to train junior level manufacturing associates.
• Support in completion of root cause investigations and CAPA implementation.
• Get Involved in Equipment and instruments Qualification and Validation activities.
• Plan, organize and maintain material inventory for manufacturing processes.
• Clearly communicate problems and observations with manufacturing management and management from other departments.

How you will make an impact:

Deliver to Plan: Execute daily production operations within a cleanroom environment. The activities will include but are not limited to Cell Expansion in an aseptic environment, Bioreactor Operations, Depth Filtration, Purification through TFF (Tangential Flow Filtration), Chromatography and Various Filtration Techniques, and Product Filling via manual, semi-automated or automated filling.

Organize and Maintain: Ensure cleanrooms are cleaned, organized, maintained and audit ready at all times. Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.

Training: Maintain individual training plan and ensure your training profile remains up to date with training readiness at all times in addition to training junior level manufacturing associates.

Administrative Tasks: Attending meetings, sending/receiving emails, participating in continuous improvement projects. When necessary, demonstrate strong technical writing abilities (Deviation initiations, work orders requests, SOPs, Logbooks, Working Instructions, Forms creation, etc.).
Perform other duties as assigned.

Work Schedule:

Any combination to include but not limited to M-F, Alternating Days, 8, 10, and 12 hours shifts. Ability to work nights, weekends and holidays.

As a Future Matican you bring:

Education

AS/BS in Biotechnology, Biology, Chemistry, or equivalent

Preferred area of study: Science related discipline

High School Diploma or Equivalent may be considered with relevant experience

Experience

Min. 3-4 years of experience in manufacturing (Min. 4-5 years of experience without AS/BS); GMP setting preferred, previous downstream experience preferred.

Knowledge

Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations:

• Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Bioprocessing Operations.
• Advanced knowledge of the manufacturing process and possesses the understanding of or ability to use the latest technologies.

Skills

Computer software skills, organization, 5S, record keeping and planning skills, multiple projects support/lead, time management, and basis lean skills is preferred

Leadership, diplomacy, written and effective oral communication, teamwork skills, independent work skills, strong work ethic.

Commitment to Excellence, Problem Solving/Decision Making/Analytical Thinking, Communication Skills, Teamwork/Cooperation/Supportiveness, Flexibility/Adaptability, Initiative/Taking Ownership, Focus on Safety, Ethical/Trustworthiness, Work Ethic/Reliability, Thoroughness, Customer Service

We Value:

Matica’s Values are at the forefront of everything we do, our culture, and the decisions we make.

• Start with Safety & Quality
• Choose the Path of Openness, Honesty, and Integrity
• Nurture Our Differences to Enable Our Collective Success
• Learn Continuously to Ensure Our Value and Relevance
• Commit to Delivering Life Altering Therapies