Sarah Hinson
Summary
Motivated professional with a strong work ethic and adaptability. Proven ability to work independently while mastering new skills rapidly. Focused on driving change management to enhance operational efficiency and effectiveness. Experienced in operations management, environmental monitoring, and implementing lean principles for continuous improvement.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Manager, Manufacturing Technical Operations
Biogen
Raleigh, North Carolina
07.2025 - Current
- Led manufacturing technical operations for antisense oligonucleotide and oral solid dose platforms.
- Assisted in developing strategies for continuous improvement initiatives within the organization's operations.
- Oversaw process optimization, troubleshooting, and technology transfer activities for efficient manufacturing.
- Collaborated with Quality, Regulatory, and Engineering teams to support product lifecycle management.
- Drove continuous improvement initiatives and implemented best practices in manufacturing.
- Ensured adherence to cGMP standards across all manufacturing operations.
- Provided strategic leadership and technical guidance for commercial and clinical manufacturing programs.
- Aided senior leadership by creating and modifying procedures for continuous improvement.
Operations Section Manager/Process Centric Team (PCT) Lead
Pfizer Inc.
Rocky Mount, North Carolina
02.2024 - 07.2025
- Set overall priorities for the PCT to ensure consistent planning, running, and improvement of the Tier 1 operating unit.
- Responsible for the management of Tier 1 operating business unit 24/7.
- Ensure that production schedules are achieved, operating within approved budgets and within labor and material standards at the lowest possible cost, meeting all necessary cGMP, Quality and Safety requirements.
- Support the installation of IMEx ecosystem standards to the Tier 1 operating unit.
- Provide management direction to senior supervisors and production employees within the associated areas.
- Ensure training requirements are met and evaluate performance to maximize the efficiency of all area personnel.
- Coach the PCT’s colleagues on problem solving and root cause analysis and through structured Gemba sessions
- Meet production goals as assigned. Evaluate any potential delays in the production schedule and make recommendations to area management to resolve the issues.
- Complete all documentation associated with the process. Assure adherence to Good Manufacturing Practices and company regulations.
- Work closely with support teams, such as process validation, site technical services, regulatory, and process engineering to complete the FDA submission requirements for each products tech transfer plan.
- Manage around 100 direct reports
Senior Continuous Improvement Specialist
Pfizer Inc.
Rocky Mount, North Carolina
11.2022 - 02.2024
- Responsible for effective implementation and sustaining two or more work area level (Tier 1) CI Loop(s).
- Lead Operational Excellence initiatives (5S, M1 investigations, etc.), develop OpEx skills of colleagues, and drive a culture of continuous improvement within their team
- Develop M1 Coach ability and partner with PCT Lead to promote continuous improvement within the PCT
- Input and analyze data from IMEx Elements and other work units to identify areas for improvement and largest sources of loss, including collaboration with CI Specialists across ecosystems.
- Collaborate with other PCT members and Element Owners on identifying and implement continuous improvement opportunities and implements corrective actions in conjunction with the appropriate enabling groups
- Attend daily Tier 1 meetings and facilitate real-time structured problem solving and lead monthly Tier 2 CI Loop meeting and T2 projects to improve the overall performance of the area.
- Work with PCT Lead, IMEx Deployment Lead, Tier 1 & 2 Element Owners, Operational Excellence and Area Leadership to build, maintain and improve IMEx within the work area and partner with shop floor colleagues, leadership, and enablers to ensure continuous improvement initiatives are identified and completed in a timely manner
Manufacturing Quality Senior Supervisor
Pfizer Inc.
Rocky Mount, North Carolina
01.2020 - 11.2022
- Provide daily supervision of MQ colleagues working on a specific shifts.
- Assure that the appropriate resources are utilized on a specific shift as they relate to CAPAs, root cause analysis, preventative actions, trending results and corrective actions, in accordance with facility standards and cGMP compliance.
- Direct manufacturing staff to uphold quality and determine when manufacturing operations must halt to properly investigate production issues
- Conduct evaluations and oversight of production personnel and processes to ensure procedures are being followed in accordance with GMP compliance and regulatory guidelines.
- Work closely with manufacturing and other support functions to troubleshoot during unexpected events.
- Work with the MQ Manager to ensure that all manufacturing and in process control procedures and specifications are followed as they relate to production, processes, and equipment
- Implement process improvements with a focus on quality processes.
- Provide input and decision making for quality on the shop floor with regard to manufacturing and deviations while providing corrective action as necessary.
- Provide real time quality impact assessments and decision on product and medical device issues, independently.
Biological Quality Analyst
Pfizer Inc.
Rocky Mount, North Carolina
07.2018 - 01.2020
- Performed aseptic environmental monitoring with the purpose of maintaining a sterile pharmaceutical production environment
- Utilized teamwork to impact production, increase efficiency, solve problems, and improve quality
Resident Assistant
Randolph-Macon College
Ashland, VA
08.2015 - 06.2016
- Managed a group of 26 residents ensuring they follow the rules and requirements of the college
- Developed activities to engage residents and provide a safe, fun environment outside the classroom
Education
Master of Science - Pharmaceutical Sciences - Drug Development
University of Cincinnati
05-2025
Bachelor of Science - Biology
Randolph-Macon College
06.2018
Skills
- Drug development
- Quality assurance
- Process optimization
- Continuous improvement
- Regulatory compliance
- Data analysis
- Goal setting
- Trend analysis
- Project management
- Effective communication
- Team leadership
- Strategic planning
- Cross-functional teamwork
- Change management
- Technical documentation
- Organization
- Self-Directed
Certification
- Pfizer Ambassador Program Team Member January 2020 –July 2025
- Pfizer Emergency Response Team (ERT) Member April 2023 – July 2025
- Randolph Macon College Young Alumni Board Member August 2023 - Present
- Varsity Tennis Team, Randolph-Macon College September 2014 - June 2018
- Student Government Association- Vice President of Administration May 2017 - June 2018
- Certified Fellow Employee (CFE): train, guide, and certify peers on how to perform their job responsibilities correctly, aseptically, and safely
- Controlled Drug Agent (CDA): provide surveillance and fill out proper paperwork (CSTRs) for controlled substances and rejects manufactured on site
- Aseptically Certified: attended multiple GMP regulated courses to become certified in FDA regulated aseptic gowning in a pharmaceutical workspace, and have maintained certification through annual course work
- Pfizer Human Factors Program (PHP) Certified: trained to conduct human performance investigations trying to narrow down the levels of root cause to be able to create corrective actions to ensure the error does not occur again
- Method 1 Certified: attended a two part course that explained and outlined the use of the DMAIC structure as part of the Lean Six-Sigma certification process
- Lean White Belt Certification (LWB): recognition for significant role in process improvements and demonstrating lean principles on the manufacturing floor
- Six Sigma Yellow Belt Certification: facilitated and performed a M1 utilizing the DMAIC structure to narrow down the root cause of a special cause event on site
- Lean Six Sigma Yellow Belt Certification (LYB): successfully lead and completed a M1 using the DMAIC process to narrow down root cause for a special cause issue in the manufacturing area
Timeline
Manager, Manufacturing Technical Operations
Biogen
07.2025 - Current
Operations Section Manager/Process Centric Team (PCT) Lead
Pfizer Inc.
02.2024 - 07.2025
Senior Continuous Improvement Specialist
Pfizer Inc.
11.2022 - 02.2024
Manufacturing Quality Senior Supervisor
Pfizer Inc.
01.2020 - 11.2022
Biological Quality Analyst
Pfizer Inc.
07.2018 - 01.2020
Resident Assistant
Randolph-Macon College
08.2015 - 06.2016
Master of Science - Pharmaceutical Sciences - Drug Development
University of Cincinnati
Bachelor of Science - Biology
Randolph-Macon College
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