Microbiologist III, Quality Control (On-Site Position)

Matica Biotechnology, Inc.; College Station (TX); On-site; USD 60,000 - 95,000; Full time

Job summary

An innovative biotechnology firm is seeking a dedicated Microbiologist III to enhance their Quality Control team. In this pivotal role, you'll leverage your expertise in microbiology to ensure the highest standards of quality in cell and gene therapy products. Your responsibilities will include performing critical microbiological analyses, environmental monitoring, and collaborating with cross-functional teams to drive continuous improvement initiatives. This position offers a unique opportunity to contribute to the development of life-altering therapies in a fast-paced, supportive environment, where your skills and insights will directly impact the success of groundbreaking biopharmaceuticals.

Benefits

Health Insurance

Retirement Plan

Paid Time Off

Professional Development

Flexible Work Hours

Qualifications

• 3+ years of experience in Biopharma GMP environments.
• Strong knowledge of microbiology and biotechnology.

Responsibilities

• Perform microbiological analyses under cGMP and GLP guidelines.
• Conduct environmental monitoring and utility sampling.

Skills

Microbiology

Quality Control (QC)

Environmental Monitoring

Aseptic Practices

Problem Solving

Communication Skills

Education

BS/BA in Microbiology

Higher Degree in Biological Sciences

Tools

qPCR

GMP Compliance

GLP Guidelines

Job description

Microbiologist III, Quality Control (On-Site Position)

Join to apply for the Microbiologist III, Quality Control (On-Site Position) role at Matica Biotechnology, Inc.

Microbiologist III, Quality Control (On-Site Position)

4 days ago Be among the first 25 applicants

Join to apply for the Microbiologist III, Quality Control (On-Site Position) role at Matica Biotechnology, Inc.

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 senior microbiologist and QC professional to join our team. This role requires expertise in QC Microbiology, preferably with cell and gene therapy industry experience. This senior microbiologist role is focused on supporting QC Microbiology lab operations and cleanroom microbiology.

How You Will Make An Impact

The day-to-day activities include but are not limited to the following:

• Perform routine assays including but not limited to endotoxin testing, particulate matter, and bioburden on various in-process, finished products and raw materials.
• Qualify product specific rapid sterility and rapid mycoplasma assays as per compendial requirements and perform routine testing.
• Perform environmental monitoring and utility monitoring for cleanrooms.
• Perform staining, characterization, identifications for microorganisms and culture maintenance and storage of environmental isolates.
• Perform testing in conjunction with laboratory investigations and deviations.
• Perform environmental and utility monitoring in clean rooms.
• Participate in various special projects according to the needs of the department.
• Participate in the drafting of procedures, protocols, policies, summary reports and other documents, as needed.
• Participate in the qualification and calibration of laboratory instruments.
• Perform investigation of microbiological data deviations and OOS/OOT.
• Perform investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Perform testing in support of facility validation activities such as EMPQs, smoke studies (airflow visualization) and media fill (aseptic process simulations).
• Analyze environmental monitoring data and prepare environmental monitoring trend reports and annual summary reports.
• Perform gowning qualifications and re-qualifications for personnel needing access to classified manufacturing areas.
• 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.
• Support internal and external cGMP manufacture and supply of high-quality cell and gene therapy products including, testing, QC release and stability data analyses and method data trending, deviations, out of specification investigations, and Certificates of Analysis creation.
• Participate in method qualification and validation, transfer, and verification testing.
• 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.
• General lab duties and all other duties as assigned.
  
  
  

Primary Responsibilities

• Perform microbiological analyses (qPCR, endotoxin, sterility, bioburden, mycoplasma testing, etc.) under cGMP and GLP guidelines.
• Perform environmental, gowning qualification sampling, and utility monitoring of clean rooms and critical processes.
• Be able to multi-task and perform Microbiology Test Methods and Environmental Monitoring with high accuracy and precision while also handling other cGMP activities.
• Ability to be a strong team player, including the ability to motivate/empower others, and resolve conflict among the team.
• Implement continuous improvement initiatives to drive Quality Control programs and ensure maximum productivity.
• Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP guidelines.
• Perform investigations to determine root cause of environmental excursions and other non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
• Ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.
  
  
  

Education

As a Future Matican you bring:

• BS/BA or higher in sciences, preferably in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, or related field.
• AS considered with the aligned experience.
  
  
  

Experience

• With a BS - Must have 3+ years of Biopharma GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical manufacturing, or laboratory environment is required.
• With an AS - Must have 5+ years of Biopharma GMP experience in biotechnology, microbiology, environmental monitoring, pharmaceutical manufacturing, or laboratory environment is required.
• 5+ year of microbiology experience in Pharmaceutical-Biotechnology is highly preferred.
  
  
  

Knowledge

• Working knowledge of:
• Microbiology and biotechnology
• Aseptic practices and clean room operations
• Statistical and auditing techniques
• Environmental control procedures/equipment
• Rapid microbiology methods and assay qualifications.
• Knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products
• Strong knowledge of current industry trends with the ability to use the latest technologies.
  
  

Skills

• Ability to interpret cGMPs and apply to non-routine situations
• Must be flexible and able to manage and prioritize multiple tasks and assignments
• Must have excellent interpersonal, 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 functional team environment, working collaboratively with others in effective ways which attain goals while encouraging teamwork and synergies throughout the organization.
• qPCR, endotoxin, particulate matter, mycoplasma testing, sterility, bioburden, environmental monitoring, and organism identification experience desired
• 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
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Ability to think critically and demonstrate troubleshooting, and problem-solving skills
  
  
  

Qualities & Attitude

• Highly motivated in the QC Microbiology field with sustained performance and accomplishments.
• Leadership traits that build and foster trust, respect, cooperation and collaboration across the organization.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  
  
  

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

Referrals increase your chances of interviewing at Matica Biotechnology, Inc. by 2x

Get notified about new Microbiologist jobs in College Station, TX.

Academic Professional Track (Non-Tenure): Clinical Professor & Department Head of Veterinary Small Animal Clinical Sciences

Tenured: Professor & Department Head of Veterinary Small Animal Clinical Sciences

Sr. Scientist (Cell Biology focus) -QCAT

Senior Scientist (Cell Biology Focus) - QCAT

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.