Building expert teams to advance science.

About the Role 

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E. standard to every program and relationship: Reliable, Outcome-driven, Scalable, and Excellent!

The Director Microbiology and Sterility Assurance be responsible for all strategy, process, compliance, and execution of critical activities to assure sterile processes, controlled environments, and biocontamination controls are maintained for the site. This includes but is not limited to: sterility assurance, environmental monitoring of the facility, quality control microbial testing, utility monitoring, and site contamination control strategy.   This position reports to the Site Head of Quality for the Memphis site. This person will be responsible to partner with Global Quality stakeholders for development, implementation, and continuous improvement of microbial control and sterility assurance standards.    The person filling this role will be responsible for the leadership, development and training of team members within their oversight as well as providing supportive leadership and strategic direction to operate with and maintain compliance to regulatory and industry quality standards in support of existing and new cellular therapy production.  

Why Rose BioSolutions 

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.

• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.

• Opportunities to grow your technical expertise and take ownership of your work.

• Close interaction with leadership and clients, enabling real influence on project outcomes.

Key Responsibilities 

• Responsible for microbiological testing and monitoring functions to support the manufacturing and release of products within the Memphis Laboratories. Ensure that these activities are timely, efficient and productive while adhering to client’s requirements and operational and quality parameters.

• Will liaise with the Manufacturing, Quality Assurance, Supply Chain, Project Management, Facilities, and other GMP Quality Control units to ensure contamination control and sterility assurance standards are maintained across all site operations.

• Preparation of Revenue and Capex Budget as per spent analysis project. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

• Maintain quality system controls for area of oversight to ensure no critical and major market complaints or audit findings.

• Ensure that all statutory and regulatory compliance standards are regularly monitored and in a state of compliance for area of oversight, as applicable.

• Responsible to oversee all PQ requirements for Environment and Utilities systems as well as routine monitoring and trending of systems.

• Take appropriate steps to reduce waste and losses in the microbiology and contamination control processes and improve efficiency in ways of working.

• Ensure timely sampling, analysis, release and trending of environmental and utility system samples.

• Ensure completion and adherence to training of subordinates in area of oversight as per the job requirement.

• Provide leadership to and ensure necessary Quality oversight to areas within span of control.

• Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee.

• Effectively model, demonstrate and live the Charles River core values of Care, Lead, Own, and Collaborate

• Lead, coach and mentor individuals from all parts of the organization with varying levels of experience. Be a valued resource for the site in all matters related quality and compliance.

• Perform all other related duties as assigned.

Qualifications and Experience

• Minimum Bachelors degree in life sciences or related field. An advanced degree in the life sciences is preferred, but not essential, based on experience

• Minimum 10 years of experience in a biologics, pharmaceutical, medical device, or related industry. 

• Minimum 5 years as a Leader with direct reports

• ISO Lead Auditor training, desirable.

• Certified Quality Engineer (ASQ), desirable

• Experience working in a GMP Biologics environment required.

• Experience preferred with a CDMO business and/or gene-modification modalities, cell-based gene therapies, and strong scientific background in QC testing required for such products.

• Complete competency with electronic document managements systems and other information management systems (QMS, ERP, LIMS,MES etc)

• Familiarity preferred with applicable regulatory requirements and compendia concerning cGMP manufacturing and testing of human cells (21CFR210, 211, 820 and 1271; Eudralex, USP, EP and ICH).

• Understanding of analytical method qualification and validation per USP, EP and ICH guidelines.

• Ability to maintain a high degree of accuracy and attention to detail.

• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.

• Outstanding verbal and written communication skills. 

• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.) is essential.

COMPENSATION DATA:

The pay range for this position is $160,000-$225,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.