Summary
Overview
Work History
Education
Skills
Websites
Certification
Phone
References
Timeline
Generic

Carsten Henriksen

Raleigh,NC

Summary

Quality Control Manager with 10 years of expertise in analytical method lifecycle management, from development to validation, in cGMP environments. Proven track record of managing quality systems and achieving a 95% on-time closure rate for deviations, investigations, and change controls. Skilled in cross-functional collaboration and team development, with a focus on implementing process improvements that drive compliance and operational excellence.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Manager, Quality Control Analytical Methods

Beam Therapeutics
Durham, NC
06.2024 - Current
  • Provide technical oversight for QC analysts during execution of in-process analytical methods to ensure safety, compliance, efficiency, and sustainability of cGMP testing across multiple programs while maintaining audit-readiness.
  • Drive critical analytical method implementation workstreams in support of program start-up and scale up including hiring, oversight of instrument qualifications, analyst training, and oversight of technical protocols for method qualification and validation.
  • Lead and developed newly established second shift QC analytical team of QC Analyst and Senior Analysts as direct reports.
  • Application of quick problem-solving, troubleshooting, and decision-making skills required for in-process testing and reporting of critical results to manufacturing team.
  • Maintained a 95% on-time closure rate for all Deviations, CAPA's and Change Controls for the QC Analytical team.

Manager, Quality Control

Cellphire Therapeutics Inc.
Rockville, MD
02.2023 - 02.2024
  • Lead and develop Cellphire's QC laboratory and staff of 7 analysts.
  • Oversee stability program, including protocol writing, sample testing (in-process and final product), data analysis, updating the regulatory submission with latest stability data, and performing trend analysis according to ICH guidelines.
  • Work with internal and external testing facilities for product testing and all applicable quality systems associated.
  • Drive continuous improvement efforts to bring all QC SOP's (both technical and compliance) to a compliant state in line with ALCOA+ principles and regulatory guidelines.
  • Serve as SME and support on deviations, laboratory investigations, root cause analysis, and impact assessments.
  • Implementation of 21CFR Part 11 compliant laboratory software and SOP guidance in preparation for LabWare LIMS implementation.
  • Interface with R&D to oversee all method qualification and transfer activities into the QC lab from both R&D and new equipment purchases (including IQ/OQ/PQ for new equipment).

Manager, Quality Control

NexImmune Inc.
Gaithersburg, MD
04.2022 - 02.2023
  • Establish and manage NexImmune's Quality Control laboratory and staff.
  • Interface with Analytical Development and Quality Assurance on method qualification, transfer, and validation (Bioassays, Potency, Flow Cytometry, ELISA, HPLC, qPCR).
  • Responsible for hiring, training, managing, and supporting the career development of QC Analytical staff.
  • Ensure audit and inspection readiness of the function at all times.
  • Serve as and SME during internal and external audits and regulatory inspections.
  • Review new and executed documents for compliance with NexImmune's SOPs and regulatory requirements.

Supervisor, QC Analytical

Catalent Gene Therapy
Baltimore, MD
04.2021 - 04.2022
  • Lead QC Analytical team with 7+ direct reports and serving as the point of contact for all QC Analytical client audit matters.
  • Oversight and maintenance of Catalent's quality control analytical testing program (including assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis).
  • Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC and Capillary Electrophoresis.
  • Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

Lead QC Scientist-Method Transfer

Catalent Gene Therapy
Baltimore, MD
12.2019 - 04.2021
  • Work closely with analytical development to lead the qualification and subsequent transfer of bioassays to the Quality Control group in compliance with GMP regulations.
  • Author and implement assay qualification and validation protocols to support Phase I/II/III and Commercial GMP manufacturing efforts.
  • Regularly work with Manufacturing and Quality Assurance staff to ensure all quality concerns, deviations, CAPAs, and laboratory investigations are resolved in a timely manner.

Associate Scientist II- Analytical Development

Catalent Gene Therapy
Baltimore, MD
08.2018 - 12.2019
  • Coordinated with other scientists to qualify GMP developed assays, edit and review qualification protocols, and wrote standard test methods for assays under development (ddPCR, qPCR, ELISA).
  • Improved and performed method transfers of GMP assays between the Analytical and Quality Control groups.
  • Spearheaded new training program for all new analysts in the plate-based group, resulting in more efficient and comprehensive training.
  • Met pertinent milestones while managing multiple projects at once.

Associate Scientist

The National Institute of Allergy And Infectious Disease
Gaithersburg, MD
03.2017 - 07.2018
  • Develop primary and secondary microfluidics (GXII, cIEF) and residual (ELISA/ECLIA, q/RT-PCR) assays for IND use on HIV, Ebola, Flu, and Malaria vaccine candidates.
  • Conduct cell culture development experiments from small scale shake-flasks to 50L bioreactors.
  • Generate technical reports, SOP's, and maintain laboratory notebooks in compliance with cGMP standards.

Research Associate I

Prometic Biotherapeutics Inc.
Rockville, MD
10.2015 - 03.2017
  • Optimized methods of testing for efficiency as well as accuracy, specifically for Nephelometry, BCS XP, endpoint/kinetic ELISAs, and gel electrophoresis for plasma protein purification products.
  • Tasked with being a member of the team spearheading assay development for the company.

Education

Bachelor's Degree - Chemistry

East Carolina University
Greenville, NC
01.2014

Skills

  • Team development and leadership
  • Quality management systems oversight
  • Knowledge of cGMP, USP, EP, and ICH standards
  • Lean Six Sigma methodologies
  • Assay development and validation
  • Method qualification and transfer
  • 5S workplace organization
  • Continuous improvement initiatives
  • Laboratory information management systems (LIMS)
  • Adeno-associated viruses (AAVs)
  • Viral vector production
  • Monoclonal antibodies (mAbs)
  • Blood product analysis
  • RT-PCR techniques
  • qPCR methodologies
  • ddPCR applications
  • ELISA assays
  • Capillary electrophoresis techniques
  • Chromatography methods
  • Flow cytometry

Certification

  • Lean Six Sigma: Yellow Belt
  • CPR/AED

Phone

cell, (540) 429-2436

References

References available upon request.

Timeline

Manager, Quality Control Analytical Methods

Beam Therapeutics
06.2024 - Current

Manager, Quality Control

Cellphire Therapeutics Inc.
02.2023 - 02.2024

Manager, Quality Control

NexImmune Inc.
04.2022 - 02.2023

Supervisor, QC Analytical

Catalent Gene Therapy
04.2021 - 04.2022

Lead QC Scientist-Method Transfer

Catalent Gene Therapy
12.2019 - 04.2021

Associate Scientist II- Analytical Development

Catalent Gene Therapy
08.2018 - 12.2019

Associate Scientist

The National Institute of Allergy And Infectious Disease
03.2017 - 07.2018

Research Associate I

Prometic Biotherapeutics Inc.
10.2015 - 03.2017

Bachelor's Degree - Chemistry

East Carolina University

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Carsten Henriksen