Jennifer Marlott
Peoria
Summary
Results-driven Program Manager known for high productivity and efficient task completion. Skilled in strategic planning, risk management, and stakeholder communication. Excel at using leadership, problem-solving, and adaptability to deliver projects on time and meet objectives. Bring focus on continuous improvement and team collaboration to drive success in complex environments.
Overview
13
13
years of professional experience
Work History
Program Manager III, Program Management
Patheon by Thermo Fisher
St. Louis
10.2019 - Current
- Collaborated with internal and external teams to drive program success.
- Facilitated core and sub-team meetings, capturing detailed notes and action items.
- Documented meeting minutes, followed up on tasks to ensure timely completion.
- Monitored risk registers and action trackers for proactive issue resolution.
- Achieved GMP and PPQ readiness for programs entering cGMP and commercial manufacturing.
- Managed customer complaints and conducted satisfaction surveys to gather feedback.
- Conducted regular program reviews with stakeholders, enhancing communication and engagement.
- Remained calm and professional in stressful circumstances and effectively diffused tense situations.
- Negotiated scope changes with stakeholders, managing expectations and ensuring program deliverables remained aligned with strategic goals and accurate revenue tracking.
- Utilized project management tools and methodologies to track program progress, identify variances, and implement corrective actions as necessary.
QA Engineer III, Supplier Quality
Patheon by Thermo Fisher
St. Louis
07.2016 - 10.2019
- Conducted audits of raw material suppliers and external contract laboratories.
- Performed qualification of raw materials for bulk drug substance formulation.
- Reviewed and approved quality assurance non-conformance reports, out-of-specification results, and invalid assays.
- Developed raw material specifications based on compendia monographs and vendor testing results.
- Reviewed documentation related to disposition, sampling, and labeling of all components.
- Managed critical change controls and executed raw material recalls efficiently.
- Created and revised standard operating procedures and policies.
- Participated in FDA, Health Canada, and PMDA inspections for commercial drug approval.
- Oversaw the development of quality control documentation, including test procedures and inspection criteria.
- Supported the quality management system adhering to cGMP, CFR, and ISO requirements.
Lead Quality Assurance Chemist
Young Dental Manufacturing
Earth City
09.2012 - 05.2016
- Executed wet bench chemistry following USP and EP test methods.
- Authored protocols, procedures, quality inspection records, and equipment qualifications.
- Developed new batch records for 30 products and established an international stability program.
- Applied cGMP, 21 CFR820, 21 CFR211, and ISO 13454:2003 guidelines.
- Analyzed data from laboratory tests and production processes to identify trends or areas of improvement.
- Investigated customer complaints regarding product quality or performance issues.
- Conducted annual evaluations of drug product quality standards to adjust specifications.
- Performed monthly internal audits across various departments to ensure compliance.
- Verified raw materials against quality standards and ensured adherence to specifications.
- Coordinated donations by organizing shipments, drafting tax letters, and maintaining product value records.
Education
Bachelor of Science - Biology
Southern Illinois University Edwardsville
Edwardsville, ILSkills
- Project management and risk assessment
- Stakeholder engagement and communication
- Program documentation and compliance
- Customer service and satisfaction
- Process improvement strategies
- Action item tracking and follow up
- Cross-functional leadership
- Problem-solving expertise
- Adaptability and flexibility
Timeline
Program Manager III, Program Management
Patheon by Thermo Fisher
10.2019 - Current
QA Engineer III, Supplier Quality
Patheon by Thermo Fisher
07.2016 - 10.2019
Lead Quality Assurance Chemist
Young Dental Manufacturing
09.2012 - 05.2016
Bachelor of Science - Biology
Southern Illinois University Edwardsville
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