Associate Director, Quality Control

Job Description

Job Description

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.

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 cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market. Come join our dedicated team and Make it Happen With Matica Bio!

Position Opportunity :

The Associate Director is responsible for day-to-day management of the Quality Control Analytical, Microbiology, and Operations teams, supporting the Senior Director. The Associate Director will also be responsible for assisting with hiring, managing departmental performance, and development of reporting staff. This individual must have proven knowledge of Quality Control System development and oversight including generation of SOPs, policies, monitoring documents, qualification / validation protocols and reports, etc. This role is recognized as a subject matter expert regarding Quality Control practices and procedures and assists the Senior Director in overseeing and delivering on all Quality Control activities. The Associate Director is responsible for assisting with the planning, scheduling, and organizing all QC activities related to meeting the compliance, supply, and strategy objectives of the department and the company. This role participates in projects aimed at cost reduction, continuous improvements, operational excellence, minimization of downtime as well as quality and safety enhancements. In this role, the individual must be able to identify and communicate improvement opportunities and results. The Associate Director will identify operational needs for projects, ensuring inter-department alignment is achieved. This individual must be able to identify and address short term, intermediate, and long-term issues rapidly, and be able to appropriately resolve conflict and prioritize work, as necessary. This role will have individual contributors and / or temporary support staff reporting to them and will direct their daily activities and personal growth.

How you will make an impact :

• Responsible for assisting the Senior Director with all activities related to the Quality Control Department.
• Oversee environmental monitoring programs including microbial testing.
• Strong adherence to GDP practices and data integrity.
• Perform, or assign, risk assessments and implement risk mitigation practices.
• Responsible for the implementation and continued operation of all Quality Control quality systems.
• Oversee stability programs, including storage, chain of custody / transport, and analyses.
• Collaborate with cross-functional teams such as Manufacturing, Quality Assurance, and Supply Chain to deliver on internal and external programs.
• Interface with Analytical Development for the transfer and qualification of test methods.
• Direct, develop and evaluate team members to assure all individuals in the Quality Control Department reach their potential.
• Responsible for representing Quality Control in internal audits, client audits and agency inspections of the site which includes the satisfactory execution, follow up, and closure of inspection and audit items to the satisfaction of all parties.
• Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.
• Lead method qualification and validation, transfer, and testing activities.
• Oversee investigations into OOS and OOT data.
• Open and resolve deviations as necessary.
• Maintain good utilization metrics to ensure headcount is proportioned appropriately with current and future workloads.
• Consistently demonstrate ownership of tasks with a proactive mindset.
• 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 excellent organization and the ability to meet internal and external deadlines.
• Provide regular, detailed updates on departmental activities and continuous improvement.
• Represent Matica in a variety of forums.
• Other duties as assigned by the Senior Director of Analytical Development and Quality Control.

As a future Matican you bring :

Education

Experience

Knowledge

Analytical Processes required for Biologic release testing

Skills

Qualities & Attitude

Competencies we look for :

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.