Analytical Lead Scientist, Quality Control

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:

Matica Biotechnology is currently offering a unique opportunity for a highly motivated QC professional to join our team with extensive expertise in QC. The Quality Control Analytical Lead Scientist brings a highly technical skillset in a variety of analytical techniques and methods within the cell and gene therapy field. The incumbent is responsible for participating in and assisting QC management in the daily activities within the QC department.

How you will make an impact:

Participating in and assisting QC management in the daily activities within the QC department including but not limited to the following:

• Serve as the subject matter expert (SME), and participate and/or lead analytical method generation, execution, qualification, and validation activities.
• Execute, lead, participate, and advise on the generation of a wide variety of Quality Control documentation including, but not limited, to method transfer and training, method qualification, and method validation.
• Responsible for, and participate with, generation, execution, implementation, and adherence to all Quality Control systems.
• Execute Quality Control Assays for internal and client-specific programs.
• Perform and maintain routine inventory.
• Observe and report any safety issues, in addition to implementing and adhering to safety procedures and policies.
• Collaborate with cross-functional teams to resolve complex method development challenges.
• Serve as technical lead to one or more client or internal programs.
• Interface with Analytical Development (AD) to transfer, train, and qualify analytical methods.
• Develop and train QC personnel in all areas associated with QC department activities and responsibilities.
• Responsible for participation 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.
• Lead, develop, perform, troubleshoot, and optimize viral vector characterization assays and reporter gene-based cell assays using insect or mammalian cell lines
• 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, deviations, out of specification investigations, and Certificates of Analysis creation.
• 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.
• Prepare reports and presentations, as necessary.
• Interface regularly with all other functions within the company such as Quality Assurance, Validations, Facilities, etc.
• Ensure departmental instrumentation is maintained, cleaned, and utilized appropriately.
• All other duties as assigned.

Primary responsibilities:

• Provide subject matter expertise to the Quality Control organization to ensure that teamwork, high morale, and innovation are fundamental components of a world-class team
• Be able to multi-task and perform Analytical Test Methods with high accuracy and precision while also handling other cGMP activities like Deviations, Out of Specification Investigations and Validation activities.
• Lead investigations into deviations, non-conformances, or quality-related issues, and perform root cause analysis (RCA) to determine corrective actions.
• Implement continuous improvement initiatives to drive Quality Control programs and ensure maximum productivity.
• Collaborate with clients to develop and customize testing protocols based on specific regulatory or product requirements.
• Review and approve all QC-related documentation, including test results, deviation reports, and stability data.
• Create active training and development plans for Quality Control staff with the objective of driving the overall competence and professionalism of the Quality functions.

As a future Matican you bring:

Education

• BS/BA or greater in sciences, preferably in chemistry, biochemistry, biotechnology, pharmaceutical sciences, or related technical field.

Experience

• 5+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing or laboratory environment.
• Experience in tech transfer, method qualification, and method validation in a cGMP-regulated environment.

Licenses/Certifications

• Organizational Excellence (CMQ/OE) is preferred

Knowledge

Strong working knowledge of:

• Aseptic practices and clean room operations
• Statistical and auditing techniques
• Environmental control procedures/equipment
• ICH guidelines
• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products

Strong knowledge of current industry trends and has the ability to use the latest technologies.

Skills

• Ability to interpret cGMPs and apply to non-routine situations
• Skills/experience in gene therapy analytics is required.
• Demonstrated independence, technical aptitude, and problem-solving skills
• Must be flexible and able to manage, organize, and prioritize multiple overlapping tasks and assignments
• Must have excellent 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.
• Demonstrated capability in coaching, training, and development of personnel
• Extensive expertise in multiple analytical methods such as ddPCR, qPCR, HPLC, Elisa, Microscopy, and Flow Cytometry required
• Capable of high through-put and high quality, Right First-Time work
• Ability to make informed and timely decisions independently
• Capable of recognizing process gaps and implementing improvements
• Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
• Ability to coach/develop teams, provide training, motivate/empower others, and resolve conflict

Qualities & Attitude

• Highly motivated in the QC field with sustained performance and accomplishments. Ability and experience in turning around and remediating compliance challenges.
• Diplomacy, negotiation skills, written and oral communication, team building skills, independent work skills, strong work ethic, coaching, delegating skills

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