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 Operations Excellence Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, continuous improvement initiatives to ensure Manufacturing consistently produces quality product. This role sits at the intersection of operational excellence, quality, training & development, and MSAT supporting efficient, compliant, and ever improving operations.

The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

Process Improvement & Optimization

• Identify and implement continuous improvement projects using Lean methodologies to improve and stabilize yield, efficiency, and process success.

• Partner with MS&T and Process Development to monitor process performance to identify data driven solutions and enhancements.

• Support technology transfer, process scale-up, and process validation to ensure smooth transitions into manufacturing.

• Partner with MS&T and Engineering to optimize equipment utilization, automation strategies, and data analytics for real time adjustments and support.

Compliance & Manufacturing Support

• Conduct timely batch record reviews and deviation investigations, ensuring long term resolution of documentation/instructional issues.

• Lead root cause analysis and corrective/preventive action (CAPA) for process deviations, non conformances, and quality issues.

• Work closely with Quality and Manufacturing teams to ensure documentation supports data integrity & good documentation practices (GDP) incompliance with FDA, EMA, guidelines.

Training and Documentation Management

• Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.

• Partner with MS&T and Training to conduct training programs for manufacturing staff to ensure adherence to cGMP, process guidelines, and quality requirements.

• Work cross-functionally to ensure employees remain qualified and up to date on process and compliance expectations.

QUALIFICATIONS:

• Minimum 3 years working within industry. Strong technical writing capabilities a plus.

• Experience within cell/gene therapies, biologics, and/or cGMP regulated environment preferred

• Knowledge of process improvement and lean methodologies preferred.

• Ability to interpret and present complex scientific data in a clear and concise manner.

• Proficient in Microsoft office suite and document management systems.

• Strong organizational and project management skills.

Compensation Data:

The pay rate for this role is $80k to $90k 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.