Sarah Chasteen
Carolina Beach
Summary
Clinical Supply and Logistics Project Manager with extensive experience at Parexel, specializing in global coordination and budget management. Demonstrated expertise in CGMP compliance and project management, ensuring timely delivery of clinical supplies. Strong leadership and client interaction skills contribute to successful outcomes in complex clinical trials.
Overview
20
20
years of professional experience
Work History
Clinical Supply and Logistics Project Manager
Parexel
Remote
05.2022 - Current
- Global coordination of the laboratory, drug, and ancillary clinical supplies for assigned studies require primary and/or secondary packaging/kitting and labeling of drug product, laboratory kit supplies, and central lab set up, ancillary projections, purchasing, distribution and returns, budget management.
- Provides consultation services to clients regarding supplies for clinical trials.
- Serves as the main point of contact between the client and other teams involved with providing supplies to sites on time.
Clinical Supplies Project Manager
ALKU Consulting with ThermoFisher
Remote
08.2021 - 02.2022
- Responsible for providing overall global coordination of the ancillary clinical supplies for the projects assigned.
- Client dedicated studies require primary and/or secondary packaging/kitting and labeling, ancillary projections, purchasing, distribution and returns, financial ancillary management for multiple projects at the same time.
- Provides consultation services to clients regarding supplies for clinical trials.
- Serves as the main point of contact between the client and other teams involved with providing supplies to sites on time.
Project Manager, Global Clinical Supplies
PPD
Remote
09.2020 - 08.2021
- Responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned.
- Responsible for managing the more complex clinical supplies studies.
- These studies require primary and/or secondary packaging and labeling design, drug projections, drug distribution and returns, drug inventory management, budgeting and developing project specific material for multiple projects at the same time.
- Provides consultation services to clients regarding global packaging, labeling, and distribution requirements.
- Serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites.
Sr. Manager, Global External Quality / Head Clinical Quality Finished Goods and Medical Device
Biogen
Morrisville
06.2019 - 09.2020
- Manage a team who represents external quality for supply chain, batch disposition/market release, and CMO activities for clinical drug substance, API, drug product intermediates, and finished goods.
- Product scope: small molecule, large molecule, OSD, Parenteral, Biologics, and Gene Therapy; Support audits and inspections related to IMP Management and GCPs, report internal and external KPIs and CMO assessments.
- Responsible for project leadership, employee hiring and retention; Investigations, CAPA, change control, supply timeline adherence, and Quality Agreement negotiation.
Manager, Quality Assurance
Quality Chemical Laboratories
Wilmington
02.2018 - 05.2019
- Oversee Quality Services for Formulations/Manufacturing/Packaging/Synthesis;
- Create, implement, and train on quality systems from the ground up as this is a new GMP facility for manufacturing for drug substance and drug product;
- Site Start-up;
- Acting project manager for Synthesis operations.
Manager, Manufacturing Quality Services
Alcami Corporation
Wilmington
04.2015 - 02.2018
- Oversee Quality Services for Manufacturing and Packaging;
- Work closely with project managers, regulatory, and manufacturing and packaging personnel to insure projects are completed to high quality standards by their due dates;
- Review and approve specifications, Master Batch Records, Executed Batch Records, Validation and Qualification protocols and reports, Deviations;
- Provide guidance and mentor Quality staff, Performance evaluations;
- Host client audits and serve as quality support during client communications;
- Regulatory Inspection host;
- Facilitate/Owner Alcami Quality Council and reporting KPIs for multiple sites;
- Involved in new Alcami system implementations and Risk Management including cross-contamination.
Sr. Quality Specialist, Quality Systems/Sr. Supervisor Quality Services
Alcami Corporation. Formerly, AAIPharma Services, Inc.
Wilmington
04.2014 - 04.2015
- New position to perform quality system implementation and improvement and integrate into new software systems;
- Example - New investigation, CAPA, and effectiveness check process design, implementation, and integration into Master Control.
Manager Project Coordination
AAIPharma Services, Inc.
Wilmington
04.2013 - 04.2014
- Oversee Project Coordinators, Lab Sample Coordinator, and Production Scheduler.
- Scheduling for packaging operations;
- Conduct meetings such as scheduling, improvements, staff, training;
- Performance reviews and goal setting for staff;
- Work closely with project managers, regulatory, and manufacturing and packaging personnel to insure projects are completed to high quality standards by their due dates;
- Interview;
- Initiate and implement projects such as scheduling boards, KPIs, scheduling requests, merging manufacturing and packaging coordinators into one group to increase efficiency and provide employee opportunities of growth;
- Face-to-face interaction with clients regarding projects;
- Drive timelines to meet client and product milestones.
Manager Quality Services
AAIPharma Services, Inc.
Wilmington
04.2012 - 04.2013
- Oversee Quality Services for Solid Dose Manufacturing;
- Work closely with project managers, regulatory, and manufacturing and packaging personnel to insure projects are completed to high quality standards by their due dates;
- Review and approve specifications, Master Batch Records, Executed Batch Records, Validation and Qualification protocols and reports, Deviations;
- Provide guidance and mentor Quality staff, perform performance evaluations;
- Participate in internal audits and client communications;
- KPIs;
- Involved in new AAIPharma system implementations;
- Merged Manufacturing and Packaging Quality into one group to increase efficiency and provide employee opportunities of growth;
- Involved in implementation of modular master batch records for packaging and manufacturing master batch record improvements.
Supervisor/Manager Packaging Operations
AAIPharma Services, Inc.
Wilmington
02.2010 - 04.2012
- Trainer;
- Scheduling;
- Performance reviews and goal setting for operators;
- Work closely with project managers, regulatory, and manufacturing and packaging personnel to ensure projects are completed to high quality standards by their due dates;
- Generate, edit, update, and approve SOPs and master records;
- Perform supervisory review of batch records, protocols, logbooks;
- Generate, edit, update, and approve planned/unplanned deviations and investigations, team interview and selection.
- Managed Packaging Operations, Phase I – Commercial;
- Investigative writing;
- Trainer;
- Scheduling for packaging operations;
- Conduct meetings such as scheduling, improvements, staff, training;
- Provide cost analysis of packaging activities;
- Performance reviews and goal setting for operators;
- Assistance power of attorney for scheduled material and product;
- All other responsibilities of the supervisor.
Quality Specialist II
AAIPharma Services, Inc.
Wilmington
04.2008 - 02.2010
- Work closely with project managers, regulatory, and manufacturing and packaging personnel to insure projects are completed to high quality standards by their due dates;
- Generate, edit, update, and approve specifications for raw materials, in-process, bulk, and all packaging components including labeling;
- Keep current with compendia changes for specification compliance;
- Batch line clearance and start-up, Inspect shipments for distribution;
- Perform raw material, packaging components, and labeling release;
- Perform quality inspections for solid dose and parenteral drug product;
- Generate, edit, update, and approve SOPs and master records;
- Perform quality review and approval of batch records, protocols, specifications, certificates of analysis/compliance, log books, clinical and commercial shipments;
- Generate, edit, update, and approve planned/unplanned deviations and investigations;
- Perform internal quality audits, KPIs.
Assistant Chemist/Quality Control
GlaxoSmithKline
Zebulon
03.2005 - 03.2008
- Training;
- Perform raw material and packaging component release testing including compendial testing.
- Attend daily production meetings;
- Work within groups of other scientists to ensure that the products are complete by their respective due dates.
Education
BA - Chemistry
North Carolina State University
01.2004
Skills
- CGMP and CGDP
- Standard operating procedures
- ICH guidelines and compendia
- IWRS, IRT, and RTSM
- Inspection readiness
- Internal and external auditing
- Quality assurance and control
- Data integrity
- Phase I commercial oversight
- Team management
- Manufacturing and packaging
- Scheduling and coordination
- Project management and client interaction
- Serialization strategies
- Validation and qualification
Accomplishments
- President of Nonprofit Organization, 9 years Board of Directors - Volunteer
- Six Sigma training Lean, 5S, Value Stream Mapping
- Aseptic Processing and Validation Overview
- PDA Conference
Skills Summary
CRO/CMO, cGMP, cGDP, SOP, ICH Guidelines, Compendia, IWRS/IRT/RTSM, Inspection Readiness, Internal and External Auditing, Quality Assurance, Quality Control, Data Integrity, Serialization, Validation/Qualification, Team Management, Manufacturing/Packaging, Scheduling and Coordination, Project Management/ Client Interaction
Affiliations
- Nonprofit Board of Directors President
Timeline
Clinical Supply and Logistics Project Manager
Parexel
05.2022 - Current
Clinical Supplies Project Manager
ALKU Consulting with ThermoFisher
08.2021 - 02.2022
Project Manager, Global Clinical Supplies
PPD
09.2020 - 08.2021
Sr. Manager, Global External Quality / Head Clinical Quality Finished Goods and Medical Device
Biogen
06.2019 - 09.2020
Manager, Quality Assurance
Quality Chemical Laboratories
02.2018 - 05.2019
Manager, Manufacturing Quality Services
Alcami Corporation
04.2015 - 02.2018
Sr. Quality Specialist, Quality Systems/Sr. Supervisor Quality Services
Alcami Corporation. Formerly, AAIPharma Services, Inc.
04.2014 - 04.2015
Manager Project Coordination
AAIPharma Services, Inc.
04.2013 - 04.2014
Manager Quality Services
AAIPharma Services, Inc.
04.2012 - 04.2013
Supervisor/Manager Packaging Operations
AAIPharma Services, Inc.
02.2010 - 04.2012
Quality Specialist II
AAIPharma Services, Inc.
04.2008 - 02.2010
Assistant Chemist/Quality Control
GlaxoSmithKline
03.2005 - 03.2008
BA - Chemistry
North Carolina State University
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