Cheryl Rindfleisch
Cayuga,NY
Summary
Experienced CMC Senior Manager II with more than 22 years in the pharmaceutical industry. Detail-oriented team leader with expertise in the preparation of Module 2 and Module 3 sections for all phases of development and commercial manufacturing for cell therapy and biologics. Demonstrates strong leadership and project management skills within cross-functional teams. Professional who thrives in a team environment yet is competent and self-motivated to handle tasks independently.
Overview
22
22
years of professional experience
Work History
Senior Manager II, CMC Cell Therapy Technical Writer and Document Management (TDM)
Bristol Myers Squibb (BMS)
01.2021 - 05.2024
- Managed team of CMC technical writers and document specialists responsible for entire end-to-end regulatory submissions process.
- Served as lead technical writer on multiple cell therapy submissions from early phase through post-marketing.
- Implemented innovative solutions for enhancing life-cycle standards to produce high-quality processes and systems to meet and exceed customer expectations.
- Collaborated with matrix teams to drive organizational success jointly as one cohesive unit.
- Created knowledge sharing innovation with cross-functional teams for authoring, system compliance, technical writing workshops, lessons learned, hot topics, etc.
- Established strong relationships with internal and external stakeholders, ensuring collaborative long-term partnerships.
- Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
- Demonstrated exceptional adaptability in navigating complex situations or rapidly changing environments with ease.
- Provided strong leadership to enhance team performance by providing comprehensive training and fostering a collaborative work environment.
- Championed process improvement initiatives that led to significant cost savings without compromising quality standards.
Senior Manager, Biologics CMC Document Management (BCDM)
Bristol Myers Squibb (BMS)
01.2017 - 01.2021
- Managed team of CMC document specialists responsible for entire end-to-end regulatory submission process.
- Served as a lead technical writer on multiple biologics submissions from early phase through post-marketing.
- Collaborated with matrix teams to drive organizational success jointly as one cohesive team.
- Championed process improvement initiative to enhance regulatory submissions with global regulatory team and technical experts.
- Provided mentorship and training to new and existing document specialists and technical writers.
- Led CMC initiative to create drug product templates for SMEs to enhance regulatory writing.
- Led initiative for new electronic data verification process, implemented training, and authored standard operating procedure.
- Partnered on creation of project timelines for commercial submissions and regulatory process training for new colleagues.
Associate Manager, Supervisor, and Resource Coordinator CMC Support Group
Bristol Myers Squibb
01.2002 - 01.2017
- Managed team of CMC document coordinators and senior specialists responsible for supporting regulatory submissions.
- Collaborated with matrix teams to drive organizational success jointly as one cohesive group.
- Managed support of internal and external technical source document requirements.
- Facilitated CMC regulatory and technical source documentation needs for Biologics Manufacturing and Process Development team.
- Partnered with global regulatory team to create process workflows for authoring and reviewing submissions.
- Biologics change agent representative for Next Generation Authoring rollout of validated regulatory system training.
- Collaborated with quality team to meet regulatory and technical source document requirements during health authority inspections.
- Successfully managed transition of third-party manufacturing documentation into validated system.
Education
M.S. in Information Technology Management -
Florida Tech University
Melbourne, FL12.2013
B.S. in Industrial Relations and Human Resource Management -
Le Moyne College
Syracuse, NY12.2002
A.A.S. in Business Administration -
SUNY Clinton Community College
Plattsburgh12.2000
Skills
- Professional Leadership
- Logistics Operations Management
- Project Management
- Detail-Oriented and Critical Thinking
- Operations Planning
- Hiring and Talent Development
- Team Leadership
- Process Improvement
- Strategic Work Planning and Prioritization
- Customer Relationship Development and Management
- Technical Writing
- Adaptability
- Troubleshooting and Problem-solving
- Cross-functional Team Collaboration
- Resource Allocation
- Decision-Making
- Interpersonal Relations
Timeline
Senior Manager II, CMC Cell Therapy Technical Writer and Document Management (TDM)
Bristol Myers Squibb (BMS)
01.2021 - 05.2024
Senior Manager, Biologics CMC Document Management (BCDM)
Bristol Myers Squibb (BMS)
01.2017 - 01.2021
Associate Manager, Supervisor, and Resource Coordinator CMC Support Group
Bristol Myers Squibb
01.2002 - 01.2017
M.S. in Information Technology Management -
Florida Tech University
B.S. in Industrial Relations and Human Resource Management -
Le Moyne College
A.A.S. in Business Administration -
SUNY Clinton Community College
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