ANGELES ENRIQUEZ
NC
Summary
GMP-regulated biologics manufacturing professional with 9+ years of progressive operations experience, including drug substance startup and scale-up support at Amgen. Train-the-Trainer qualified and an active chromatography trainer with experience developing SOPs, JHAs, and training resources, as well as leading new-hire onboarding across downstream operations. Brings manufacturing systems expertise, investigation support, data review, and cross-functional problem solving to enable reliable operations and training readiness.
Overview
9
9
years of professional experience
Work History
Associate Manufacturing II
Amgen
Apex, NC
09.2024 - Current
- Support startup and scale-up activities for a drug substance manufacturing facility, maintaining GMP compliance and operational readiness.
- Execute batch operations through MES (ESPs) with accurate, complete, and compliant documentation practices.
- Developed SOPs, JHAs, and training resources to ensure clear task execution and maintain GMP-compliant operations.
- Serve as a chromatography trainer, providing hands-on training and coaching to associates to build technical capability and support consistent, compliant execution.
- Lead new-hire onboarding across downstream operations, introducing associates to processes, equipment, expectations, and compliant work practices.
- Reviewed manufacturing data and process performance to identify trends and operational risks, driving opportunities for continuous improvement.
- Partner with Engineering, Automation, Quality, and C&Q teams to support manufacturing-system integration and successful operation.
- Support structured troubleshooting and quality-driven investigations; maintain inspection-ready documentation when manufacturing events occur.
- Use SAP and LIMS to monitor materials, samples, and manufacturing data supporting execution and timely operational decision-making.
- Collaborated with site stakeholders to resolve issues impacting compliance and schedule adherence.
Manufacturing Associate II
Seqirus
Holly Springs, NC
07.2021 - 09.2024
- Executed downstream manufacturing activities adhering to GMP requirements, established production schedules, and documented activities to ensure quality and compliance.
- Operated chromatography, centrifugation, ultrafiltration, DeltaV, and PI systems in support of vaccine manufacturing operations.
- Worked closely with Quality, Engineering, and Operations teams to address manufacturing challenges and sustain production objectives.
- Participated in investigations and troubleshooting, driving process improvements that enhanced manufacturing reliability and elevated product quality.
- Used SAP and LIMS to track production data, inventory status, and laboratory information.
Team Lead
GKN Driveline
Sanford, NC
07.2017 - 06.2021
- Led daily production operations, balancing labor, equipment, material availability, and scheduling priorities in a fast-paced environment.
- Monitored KPIs and reported production performance, risks, and recovery plans to leadership and cross-functional partners to ensure informed decision-making.
- Investigated production disruptions, identified contributing factors, and implemented corrective actions to restore normal operations.
- Facilitated interdepartmental collaboration to resolve scheduling conflicts and streamline production flow, leading to backlog reduction.
Education
Certificate - BioWorks
CCCC
05-2020
High School Diploma -
Lee County High School
Sanford, NC06-2014
Skills
- Drug substance manufacturing; GMP compliance and documentation
- SOP, JHA, and training-resource development; downstream new-hire onboarding and operational training
- Train-the-Trainer qualified; hands-on associate training and chromatography coaching
- Manufacturing investigations, deviations/CAPA support, root-cause analysis (5 Whys, Fishbone)
- Technical documentation, data trending, process performance review, and operational risk identification
- MES (ESPs), SAP, LIMS, DeltaV, and PI systems
- Cross-functional collaboration with Manufacturing, Quality, Engineering, Automation, and C&Q
- Continuous improvement, structured problem solving, stakeholder communication, and bilingual English/Spanish
Timeline
Associate Manufacturing II
Amgen
09.2024 - Current
Manufacturing Associate II
Seqirus
07.2021 - 09.2024
Team Lead
GKN Driveline
07.2017 - 06.2021
Certificate - BioWorks
CCCC
High School Diploma -
Lee County High School