Hybitha V. Coleman
Little Rock,USA
Summary
To utilize my skills and experience in a company setting allows me to achieve personal growth and development in the advancement of my career. Flexible and versatile - able to succeed under pressure. Poised and competent with demonstrated ability to easily carry out necessary job tasks. Thrive in deadline-driven environments. Excellent team-building skills.
Versatile Senior Manager specializing in Manufacturing and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
17
17
years of professional experience
Work History
SR. MANAGER OF STERILE MANUFACTURING
SCA PHARMA (503B) Sterile Manufacturing
12.2024 - Current
- Lead Manufacturing team in compounding and API formulations of numerous products and controlled/non=controlled substances
- Initiate Deviations, CAPAS, Change Controls and adhere to any Quality Issues
- Cross-functional Trainer for Compounding and Formulations
- Responsible for Goal Setting and Reviews for Manufacturing Team
- Cleanroom Support and Coaching
- Author SOP’s, Work Instructions, Supporting Documentation
- Scheduling of Manufacturing activities
- Lead Daily Huddles to discuss scheduling and previous issues in the Manufacturing area
- Internal Audit SME for Manufacturing, Compounding, Formulations API’s
- Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
- Provided strong leadership to enhance team productivity and morale.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Consistently met or exceeded annual performance targets set by senior leadership.
ASSOCIATE DIRECTOR OF EXTERNAL MANUFACTURING
Obsidian Therapeutics
06.2022 - 09.2024
- Head Manufacturing point of contact for Obsidian Therapeutics
- Manufacturing Liaison for Obsidian Therapeutics and it’s CDMO’s
- Actively support the manufacturing of clinical TIL(OBX-115) process for Obsidian Therapeutics
- Person -In Plant for all Manufacturing activities for Obsidian Therapeutics CDMO’s
- Cross-functional collaboration with CDMO’s (Manufacturing, Quality, Regulatory, Supply Chain)
- Initiate Deviations/CAPA’s and Change Controls Internally and Externally between Obsidian Therapeutics and it’s CDMO’s
- Review and Author Process SOP’s, Job Aids and Work Instructions
- Develop Sr.Scientist’s of External Manufacturing (Person in Plant)
- Contract negotiations for Manufacturing activities (Scope of Work, Capacity, Quality Agreements,Supplier Qualifications)
- Regulatory inspection support and audits
- Continuous process improvement projects change leader
- Streamlined aseptic fill/finish process to increase yield of final drug product (Adjustments, Contamination Controls, New Product Medical Device Incorporation)
- Reduced operational costs by identifying inefficiencies and implementing cost-saving measures in various departments.
- Established strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration.
- Assisted senior leadership in managing all aspects of operations.
SR. MANUFACTURING MANAGER /ASSOCIATE DIRECTOR OF EXTERNAL MANUFACTURING
Allovir Inc.
05.2021 - 06.2022
- Oversee day-to-day manufacturing campaigns at our CDMO (Charles River Laboratories Memphis, TN)
- Technical Transfer lead for current and future Allovir’s allogenic therapies
- Cross-functional collaboration with CDMO and Allovir
- Initiate Deviations/CAPA’s and Change Controls
- Review and Author Process SOP’s, Job Aids and Work Instructions
- Develop Bioprocessing Engineers (Person in Plant)
- Contract Negotiations with CDMO (SOW’s, Manufacturing Capacity, Supply Chain)
- Responsible for Reviews/Goalsetting for personnel
- Regulatory inspection support
- Continuous process improvement lead
- Incorporated efficiency improvement procedures for sterile injectable product lines resulting in high product throughput (automation, visual inspections, pre-filled syringe new product engineering runs)
- Implemented advanced analytics tools to monitor performance metrics in real-time, enabling faster identification of potential issues before they escalate.
- Reduced production costs through strategic supplier negotiations and effective inventory management practices.
- Collaborated with engineering and design teams to incorporate feedback from the production floor, leading to improved product manufacturability.
- Streamlined production schedules to meet customer demand while minimizing overtime expenses and maintaining employee satisfaction.
MANUFACTURING MANAGER CAR-T (CELL THERAPY DIRECT OPERATIONS)
Bristol Meyers Squibb
02.2020 - 05.2021
- Manage daily manufacturing operations for Car-T (Ide-cel)”ABECMA” operations
- Coordinate scheduling of the manufacturing for Cell Therapy Direct Operations
- Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
- Author/Review SOP’s and related documents for Manufacturing Department
- Conducted root cause analysis investigations to identify areas for improvement in manufacturing processes, leading to increased efficiency and fewer defects.
- Adhere to any safety issues and concerns
- Partnered with vendors and suppliers to effectively manage and budget.
- Collaborated with cross-functional teams to ensure on-time delivery of products while maintaining high quality standards.
- Conducted performance reviews each quarter, offering praise and recommendations for improvement.
MANUFACTURING MANAGER (Downstream Purification)
IMMUNOMEDICS INC
06.2015 - 01.2020
- Manage daily operations purification/ cell culture manufacturing activities for IMMU-132 (Sacituzuzmab Govitecan)
- Delegate workflow and responsibilities to downstream team
- Manage numerous projects within the organization
- Process mapping for Sterile injectable lines resulting in employing robotic systems for reduction of human error and contamination controls for maximum final drug product delivery while minimizing variability under our incorporated OPEX programs
- Initiate Deviations/ Investigations/Change Controls/SOP’s
- Developed long-term strategies for manufacturing operations, aligning with company goals and objectives to drive sustainable growth.
- Collaborate with cross-functional departments
- Established performance metrics for staff members, enabling effective evaluation of individual contributions and overall team success.
- Collaborate with numerous workstreams for process improvements
- Enhanced product quality by performing regular audits, enforcing strict adherence to industry standards, and implementing corrective actions when necessary.
- Applied lean principles to improve workflow and quality and reduce waste.
- Monitored manufacturing variances to achieve quality improvement while resolving product process and equipment problems
- Acted as the liaison between executives, manufacturing teams and other cross functional departments
SR. FORMULATION TECHNICIAN
TEMPTIME CORPORATION
01.2013 - 01.2015
- Coordinates and executes activities in the intermediates and bulk materials manufacturing laboratories to meet production and R&D needs while maintaining a well-organized and clean environment that satisfy ISO and GMP environment
- Leads and/or participates in projects to improve manufacturing and quality process aligned with company objectives and strategies
- Essential Duties and Responsibilities:
- Maintains and adheres to all company safety policies and procedures
- Manufactures intermediates and bulk materials for production and according to product specifications, established procedures, and production schedule
- Performs pre-production activities including proofing reference rings prior to production
- Work closely with Supply Chain concerning raw materials and intermediates availability
- Scheduling and coordinating the manufacturing of intermediates and bulk materials for production
- Assist with the development and execution of validation projects and protocols, writing and editing SOPs, work instructions, part specifications, and other necessary QA documentation
- Leads process improvement efforts (5S, Six Sigma, Kaizen)
- Lean Manufacturing in the Ink /Formulation lab
- Assist as an IFS Super-user for the Formulation department
- Training operators on Ink/Formulation Manufacturing Process
- Assist with in-process testing to assure manufactured materials meet specifications
- Serve as back-up for QC testing of manufactured materials when required
- Collects and analyzes data from the manufacture of intermediates and bulk materials; based on data analysis makes recommendations for improvement
- Works with outside vendors and contractors to determine product specifications, purchase of equipment and materials, and evaluate products according to specifications and quality standards
- Effectively plans and utilizes time and resources to meet business needs and achieve business objectives
- Collaborated with cross-functional teams to ensure successful product launches and meet project deadlines.
- Led pilot-scale production runs to validate new formulations before full-scale manufacturing.
SR. CELL PROCESSING ASSOCIATE
DENDREON CORPORATION /NOVARTIS PHARMACEUTICALS
01.2009 - 01.2013
- Aseptic manufacturing of clinical and commercial blood - derived components in a clean room environment.
- Effectively communicated relevant updates or changes within the team to keep everyone informed about any potential impacts on day-to-day operations.
- Contributed significantly to the achievement of departmental goals through consistent delivery of high-quality results under tight deadlines.
- Good manufacturing practices and aseptic processing using Standard Operating Procedures.
- Provide support for the Investigation and Recall of non-conforming materials.
- Leading, mentoring and training other associates in clean room behavior, aseptic process techniques, GMP documentation, quality systems and safety.
- Identified and resolved process issues to drive optimal workflow and business growth.
- Prioritized initiatives to increase success rates of strategic projects.
- Adhered to established policies, procedures and compliance for satisfactory audit rating.
Education
B.S - Chemical Engineering
SOUTHWESTERN OKLAHOMA STATE UNIVERSITY
Weatherford, OK05.1997
Skills
- Leadership/Mentoring
- Project Management
- CDMO/Contract Manufacturing Experience
- Investigative Reports/Change Controls/Deviations
- Author SOP’s/ Work Instructions/Job Aids
- Extensive Cell and Gene Therapy Experience
- Microsoft Office/Excel/Power point/Office Suite
- Early and Late- stage clinical trials experience
- GMP Focused
- Six Sigma Green Belt Certification
- 503(B) Sterile Compounding
- Controlled/Uncontrolled Substance Manufacturing
- Aseptic Techniques
- Sterile Injectables Formulation Fill/Finish
- Oral/ Solid Dosage Experience
- Management/Supervisory Experience
- FDA audits/ PAI’s/BLA/IND submissions
- API
- Drug Substance/ Drug Product Experience
- Small Molecule Experience
- CAR-T Experience
- Technical Transfer Lead
- Supply Chain
- MES, SAP, Inventory Control Management Systems
- Strategic planning
- Operations management
- Operations planning
- Budget oversight
- Data analytics
- Reporting oversight
- Talent development
Timeline
SR. MANAGER OF STERILE MANUFACTURING
SCA PHARMA (503B) Sterile Manufacturing
12.2024 - Current
ASSOCIATE DIRECTOR OF EXTERNAL MANUFACTURING
Obsidian Therapeutics
06.2022 - 09.2024
SR. MANUFACTURING MANAGER /ASSOCIATE DIRECTOR OF EXTERNAL MANUFACTURING
Allovir Inc.
05.2021 - 06.2022
MANUFACTURING MANAGER CAR-T (CELL THERAPY DIRECT OPERATIONS)
Bristol Meyers Squibb
02.2020 - 05.2021
MANUFACTURING MANAGER (Downstream Purification)
IMMUNOMEDICS INC
06.2015 - 01.2020
SR. FORMULATION TECHNICIAN
TEMPTIME CORPORATION
01.2013 - 01.2015
SR. CELL PROCESSING ASSOCIATE
DENDREON CORPORATION /NOVARTIS PHARMACEUTICALS
01.2009 - 01.2013
B.S - Chemical Engineering
SOUTHWESTERN OKLAHOMA STATE UNIVERSITY