Analyst II, Quality Control

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Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose‑built GMP facility in College Station, Texas, we provide rapid development and scale‑up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.

Matica Biotechnology is currently offering a unique opportunity for a highly motivated Quality Control professional to join our team with expertise in QC and gene and cell‑based assays preferably with cell and gene therapy experience. The Analyst II, Quality Control is responsible for assisting the QC Team in the day‑to‑day activities in the QC lab.

• Perform routine assays on various finished products, raw materials, and in‑process samples.
• Record test results, document processing steps on Quality Control assays while adhering to good documentation practices (GDP).
• Perform testing in conjunction with laboratory investigations and deviations.
• Interface with Analytical Development (AD) to transfer, train, and qualify analytical methods.
• Execute method qualification and validation, tech transfer, and verification testing with minimal supervision.
• Participate in various special projects according to the needs of the department.
• Draft procedures and/or operating manuals, as needed.
• Participate in the qualification and calibration of laboratory instruments.
• Perform testing in support of facility validation activities.
• Train QC personnel as appropriate.
• Collaborate with cross‑functional teams to resolve complex method development challenges.
• Responsible for participation in internal audits, client audits and agency inspections of the site.
• Ability to communicate and work in a fast‑paced team environment.
• Ability to work both independently and in a team‑oriented environment.
• Support internal and external cGMP manufacture and supply of high‑quality cell and gene therapy products including in‑process testing, QC release and stability data analyses and method data trending, deviations, out-of‑specification investigations, and Certificates of Analysis creation.
• Perform routine inventory.
• Ensure lab is maintained (organized, clean, & properly supplied).
• Observe and report any safety issues.
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure Quality Control functions remain in compliance with applicable company requirements and global regulations.
• Maintain a high level of integrity and professionalism when interacting with co‑workers and clients.
• All other duties as assigned by Quality Control Management.

• BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.
• Or 6+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.

• 2+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.

• Aseptic practices and clean room operations
• Statistical and auditing techniques
• Environmental control procedures/equipment
• GMP, FDA, ICH, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
• Current industry trends and can use the latest technologies

• Must be flexible and able to prioritize multiple tasks and assignments
• Ability to interpret cGMPs and apply to non‑routine situations
• Must have strong verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in cross‑function team environment, working collaboratively with others in effective ways which attain goals while encouraging teamwork and synergies throughout the organization.
• Any of the…