Manager, Quality Control Microbiology

We are seeking a Manager, Quality Control Microbiology to join Aspect’s Quality team. Reporting to the CTOO, you will oversee and execute essential activities to ensure microbial control across materials, environments, and processes for Aspect’s bioprinted tissue therapeutics.  As a key contributor to our Quality team, your work will directly impact the success of our mission and the patients we are committed to treating.

Responsibilities

• Lead the microbiology quality control team, providing guidance, training, and support to ensure efficient and effective execution of activities.
• Develop and implement robust quality control strategies and protocols for microbial control of raw materials, environments, and processes in compliance with regulatory requirements.
• Oversee and execute on the sampling and analysis of materials, personnel, and environment to monitor microbial contamination and ensure product quality.
• Perform routine quality control microbiology tests (endotoxin, bioburden, sterility) and environmental monitoring for cleanroom and personnel.
• Maintain accurate quality records and manage media and supplies inventory.
• Assist in the qualification and validation of microbiological equipment and methods.
• Support troubleshooting, identify process improvements, and ensure compliance with Good Manufacturing Practice (cGMP) and Good Documentation Practices (GDP)  standards.
• Collaborate cross-functionally with R&D, Process Development, and Operations teams to address quality-related issues and drive continuous improvement initiatives.
• Stay current with industry trends, best practices, and regulatory requirements related to microbiology quality control, and incorporate learnings into the development of quality systems and processes.

Qualifications                                                                         

• Education + Experience: BSc in a related Life Sciences discipline along with a minimum 6 years experience in a cGMP facility or previous experience in a QA/QC role within a similar biotechnology setting.
• Quality Knowledge: Demonstrated robust understanding and proven track record in effectively navigating and applying Quality Systems.
• Microbiology Expertise: Strong background in microbiology, with hands-on experience in microbial testing, environmental monitoring, and contamination control within a lab-based setting.
• Team Management: Proven ability to lead, train, and develop a quality control team, fostering a collaborative and productive work environment.
• Phase-Appropriate Approach: Experience working in early-phase development settings, with an understanding of phase-appropriate quality requirements and scalability considerations.

Who You Are                                                                          

• Problem Solver: You love immersing yourself in difficult technical problems and coming up with solutions that work. You think outside the box and use your experience and intuition to identify when such solutions are realistic.
• Detail-Oriented & Meticulously Organized: You have outstanding attention to detail and take pride in your work. You can multitask, prioritize competing deadlines, and have a track record for delivering work on time.
• Thrive in Ambiguity: You are highly adaptable, agile, and poised when faced with change, ambiguity, and competing priorities.
• Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.
• Effective Communicator: You are an active listener who can effectively communicate to different audiences in diverse situations.
• Go-Getter: You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary, and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.

The hiring range for this role is $89,300 - $105,000 annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.