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 Onboarding and Operational Trainer serves as a key member of The ROOT Partner Program — Rose Onboarding & Operational Training and is responsible for the structured planning, development, coordination, execution, and continuous improvement of training activities supporting cGMP, cGDP and technical operations within Cell Therapy Manufacturing. 

This position serves as an on-floor coach, trainer, mentor, and Manufacturing subject matter resource responsible for helping Biomanufacturing personnel become confident, competent, and qualified to independently execute cell and gene therapy manufacturing operations. 

The ROOT Partner will support personnel throughout their development journey — from initial onboarding and foundational GMP behaviors through process-specific training, hands-on qualification, independent execution, and continued competency. 

The position partners closely with Manufacturing leadership, Quality, MSAT, QC, Training, and other cross-functional teams to build a culture centered on: 

Patient Safety | Quality | Ownership | Technical Excellence | Right-First-Time Execution | Continuous Improvement 

WHAT IT MEANS TO BE A ROOT PARTNER 

ROOT Partners are selected to help develop the next generation of Rose BioSolutions Manufacturing professionals. 

As a ROOT Partner, you will: 

• Develop People: Coach and mentor Biomanufacturing personnel as they progress from onboarding through independent qualification. 

• Build Confidence: Create an environment where employees can practice, ask questions, understand the “why,” and develop confidence before independent GMP execution. 

• Set the Standard: Model strong aseptic behaviors, documentation practices, contamination control, procedural adherence, and professional accountability. 

• Stay Connected to the Floor: Routinely observe manufacturing operations and provide real-time coaching rather than limiting training to a classroom. 

• Strengthen Performance: Identify recurring errors, knowledge gaps, and human-performance risks and turn those observations into meaningful improvements. 

• Shape the Program: Help improve Rose BioSolutions’ Manufacturing curricula, qualification strategy, training materials, and practical learning experiences. 

• Support Commercial Readiness: Help develop a Manufacturing workforce capable of consistently executing increasingly complex cell therapy processes as programs progress toward commercial manufacturing. 

• Make an Impact: Your success is measured not simply by how many people complete training, but by how effectively they perform after qualification. 

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:  

Onboarding & Development 

• Serve as a ROOT Partner for newly hired and developing Biomanufacturing personnel. 

• Lead structured onboarding activities covering cGMP, cGDP, GTP, aseptic processing, contamination control, cleanroom behaviors, documentation, and Manufacturing expectations. 

• Develop and document individualized training and qualification plans based on role requirements and assigned manufacturing processes. 

• Coordinate training schedules, trainers, facilities, equipment, materials, documentation, and production resources required to support trainings. 

• Track trainee progression from initial onboarding through independent operator qualification. 

• Trend trainee performance against compliance metrics for the operations department. 

Hands-On Cell and Gene Therapy Training 

• Conduct classroom, laboratory, simulation, and hands-on Manufacturing training. 

• Train personnel within controlled and classified Manufacturing environments when appropriate. 

• Provide training and coaching for cell therapy operations that may include: 

• Aseptic processing and manipulations 

• Cell culture and expansion 

• Media and solution preparation 

• Cell counting 

• Harvesting and cell recovery 

• Formulation 

• Filling 

• Sampling 

• Cryopreservation and thawing 

• Cleaning and sanitization 

• Material transfer 

• Gowning and cleanroom behaviors 

• Equipment operation and troubleshooting  

• Batch record execution 

• Good Documentation Practices 

• Ensure operators understand not only what a procedure requires but why critical steps, controls, and behaviors matter to product quality and patient safety. 

Operator Qualification 

• Conduct and document Operator Qualifications and competency assessments. 

• Evaluate personnel against established technical, procedural, documentation, and behavioral expectations. 

• Determine readiness for independent GMP execution based on demonstrated competency rather than training completion alone. 

• Provide additional coaching and remedial training when performance expectations are not met. 

• Partner with supervisors and managers to develop appropriate improvement plans for trainees requiring additional support. 

On-the-Floor Coaching 

ROOT Partners are expected to remain connected to Manufacturing operations after personnel are qualified. 

Responsibilities include: 

• Routinely observing Biomanufacturing operations. 

• Coaching personnel on aseptic technique, cleanroom behaviors, contamination control, documentation, communication, and procedural adherence. 

• Reviewing executed Manufacturing documentation for recurring errors and training opportunities. 

• Reinforcing appropriate escalation and questioning behaviors when abnormal conditions are observed. 

• Supporting human-performance tools including effective communication, peer verification, point-and-call, situational awareness, and attention to detail. 

Investigation & Continuous Improvement Support 

• Participate in deviation investigations, root cause analyses, CAPAs, and performance improvement activities when training, operator performance, or human factors may have contributed to an event. 

• Help distinguish true training deficiencies from procedural, process, equipment, environmental, organizational, or human-performance causes. 

• Support development of sustainable corrective actions rather than defaulting to retraining when training is not the underlying root cause. 

• Evaluate deviation, CAPA, audit, and operational performance trends to identify opportunities for proactive training. 

Training Program Development 

• Develop and continuously improve ROOT training materials, including: 

• Instructor-led presentations 

• Hands-on exercises 

• Training scenarios 

• Qualification checklists 

• Knowledge assessments 

• Practical assessments 

• Job aids 

• Visual standards 

• Coaching guides 

• Trainer guides 

• Review new and revised SOPs, batch records, process flows, equipment, and client requirements to determine training impact. 

• Keep training content aligned with current approved procedures and regulatory expectations. 

• Partner with Manufacturing, Quality, MSAT, QC, Engineering, Validation, and other SMEs during process implementation, technology transfer, PPQ, and commercial-readiness activities. 

QUALIFICATIONS:

• Bachelors degree in the biological field preferred 

• 5 plus years of experience working within a cGMP and cGDP environment  

• Experience in facilitation, training, or adult learning and teaching preferred 

• Strong capability for logical and analytical thinking. 

• Excellent communication and interpersonal skills 

• Demonstrated ability work with others in a multicultural environment 

• Multi-disciplinary knowledge of the biotech or cellular manufacturing industry preferred. 

Compensation Data:

The pay rate for this role is $70K-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.