Manager, Manufacturing Readiness

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!

Position Opportunity:

This position is responsible for leading manufacturing readiness activities for external CDMO partners supporting cell and gene therapy (CGT) programs across clinical and commercial stages. This role ensures CDMO facilities, processes, materials, quality systems, and personnel are fully prepared to execute complex CGT manufacturing in compliance with Good Manufacturing Processes (GMP) and regulatory expectations.

Serving as a key operational leader and CDMO-facing representative, this position drives cross-functional alignment, proactively identifies and mitigates readiness risks, and ensures seamless execution of technology transfer, engineering runs, validation, and routine manufacturing for autologous and/or allogeneic therapies.

How you will make an impact:

Manufacturing Readiness Leadership

• Lead end-to-end manufacturing readiness strategy and execution for assigned CGT clients.
• Define readiness criteria and success metrics for key milestones including NPI, tech transfer, engineering runs, PPQ (as applicable), and campaign start.
• Ensure alignment on readiness criteria for key milestones (e.g., tech transfer completion, engineering runs, PPQ, campaign start).
• Develop, maintain, and own manufacturing readiness plans, timelines, and dashboards.
• Identify readiness gaps, risks, and dependencies; drive mitigation plans and escalate as needed.

CDMO Oversight & Relationship Management

• Serve as the primary manufacturing readiness lead and escalation point for client partners.
• Schedule and lead readiness meetings, operational reviews, and governance forums with clients.
• Ensure client alignment with CGT-specific requirements including aseptic processing, chain of identity/chain of custody (COI/COC), raw material controls, and closed-system operations.
• Assess operational readiness for cell and gene therapy manufacturing models.

Cross-Functional & Program Leadership

• Partner closely with Manufacturing, Quality, Supply Chain, Process Development, Quality Control, Analytical Development and Program Management departments.
• Drive cross-functional inputs and decision-making related to manufacturing readiness.
• Ensure readiness activities are aligned with client timelines and supply strategies.
• Mentor and guide junior readiness or project management staff as applicable.

Quality, Compliance & Inspection Readiness

• Lead GMP readiness efforts including documentation, training, material availability, equipment qualification status, and quality system alignment.
• Coordinate readiness activities in support of audits, inspections, and regulatory submissions.
• Ensure CDMO manufacturing readiness aligns with internal procedures, quality agreements, and regulatory expectations (FDA, EMA, etc.).
• Support deviation, CAPA, and change management discussions impacting readiness.

CGT-Specific Operational Readiness

• Coordinate readiness for CGT-specific operational complexities, including:
• Material handling and logistics
• Viral vector supply and release dependencies
• Cryopreservation, storage, and shipping readiness
• Single-use systems and closed processing platforms
• Support readiness for rapid change and process evolution common in early-stage CGT programs.

Reporting & Continuous Improvement

• Prepare and present readiness status, risk assessments, and executive summaries to senior leadership.
• Develop and improve readiness frameworks, templates, and best practices for CGT manufacturing.
• Drive continuous improvement in CDMO readiness processes and execution.

Perform other duties as assigned and / or required.

As a future Matican you bring:

Education & Experience

• Bachelor’s degree and 7–10+ years of experience in cell and gene therapy, biologics, advanced therapy or similar regulated production environments
• Experience with viral vector manufacturing and supply chain integration.
• Direct experience with tech transfer, process validation, or late-phase/commercial readiness in CGT.
• Prior participation in regulatory inspections or pre-approval readiness activities.
• PMP or formal project/program management training.

Knowledge

• Demonstrated experience working with or managing CDMO partners in a GMP environment.
• Strong understanding of CGT manufacturing processes, quality systems, and regulatory expectations.

Skills

• CGT manufacturing readiness leadership
• CDMO oversight and governance
• GMP compliance and inspection readiness
• Proven ability to lead cross-functional teams in a matrixed organization.
• Excellent organizational, communication, and stakeholder management skills.
• Risk management and decision-making
• Strategic planning with operational execution

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.

• 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