Sruthy Varghese
Missouri City
Summary
Dynamic Associate Manager at Immatics, specializing in tech transfer and CMC program management, with a proven track record in regulatory compliance and assay development. Demonstrated ability to lead cross-functional teams, enhancing operational efficiency, and driving project success. Proficient in flow cytometry and effective communication, fostering collaboration to achieve organizational goals. Aiming to leverage expertise to contribute to innovative advancements in biopharmaceuticals.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Associate Manager, CMC-PD/AD
Immatics
Houston
06.2024 - Current
- Led tech transfer activities, ensuring a seamless transition of analytical methods from R&D to manufacturing while maintaining CMC (Commercialization, Manufacturing, and Clinical) requirements.
- Managed pre-qualification assays for analytical method validation, ensuring regulatory compliance for clinical and commercial stages.
- Conducted assay pre-qualifications, ensuring methodologies met industry standards before full validation.
- Partnered with quality, manufacturing, and regulatory teams to align assay development with product lifecycle needs.
- Developed and delivered training programs on analytical techniques, enhancing team proficiency, and regulatory adherence.
- Created a training plan aligning all teams on general lab procedures, analytical assays (flow and non-flow assays), processes, and manufacturing, ensuring streamlined and standardized operations for BLA readiness.
- Acted as a liaison between the R&D and QC teams, ensuring effective communication on validated assays.
- Assisted in managing cross-functional teams, implementing risk mitigation strategies, and tracking project milestones.
- Utilized project management tools (MS Project, JIRA) to manage program timelines, resource allocation, and deliverables.
- Negotiated contracts with vendors to secure favorable terms and pricing.
- Interviewed prospective employees and provided input to HR on hiring decisions.
- Participated in regular meetings, took copious notes for all attendees and distributed details to relevant stakeholders.
- Participated in cross-functional project teams to ensure successful completion of projects within timeline and budget constraints.
Senior Research Associate, Flow Lab-CMC PD/AD
Immatics
Houston
12.2019 - Current
- Led flow cytometry assay validation for QC and process development, ensuring Phase 3 readiness.
- Provided training and technical support for flow cytometry users, improving operational efficiency, and compliance.
- Conducted gap analyses to optimize core lab workflows and instrument performance.
- Maintained and troubleshot flow cytometry instruments (Lyric, Fortessa, Cytek Aurora, Aria III, MACSQuant 10).
- Qualified the Lyric instrument by working closely with the validation team to ensure compliance.
- Assisted in writing the User Requirements Specification (URS) and Impact Assessment for the Lyric system.
- Performed the Performance Qualification (PQ) for the system, ensuring it met operational and regulatory standards.
- Supported technology transfers by integrating new flow cytometry methodologies into routine analysis.
- Coordinated with vendors for the maintenance and calibration of lab equipment.
- Maintained accurate records of all laboratory activities including experiment results, observations.
- Delivered research findings in presentations, papers and spreadsheets to stakeholders.
- Drafted standard operating procedures for use in the laboratory environment.
- Trained new personnel on proper laboratory procedures, safety protocols, instrument operation, software applications.
Research Assistant II
MD Anderson Cancer Center
Houston
09.2018 - 12.2019
- Conducted in vitro and in vivo studies on drug treatments for melanoma
- Performed protein purification, RNA/DNA sequencing, and FACS analysis for molecular characterization of tumor cells
- Managed tumor injection, collection, and splenectomy processes for preclinical studies
- Interpreted test results and determined need for retesting.
- Kept lab space and equipment clean to prevent contamination with hazardous substances.
- Participated in extra training and courses to refine and improve upon industry knowledge.
- Performed routine checks on sensitive lab equipment to achieve consistent and high-performing functionality.
- Created detailed summaries of existing studies for use in further investigations.
- Assisted in the design and implementation of experimental protocols.
Education
Master of Business Administration (MBA) - Management
Western Governors University
Salt Lake City, UT06.2024
Master of Science - Biotechnology
University of Houston-Clearlake
Houston, TX05.2018
Bachelor of Science - Mathematical Biology
University of Houston
Houston, TX12.2014
Skills
- Tech Transfer and CMC Program Management
- Regulatory compliance
- Assay Development and Qualification
- Project Management
- Cross-functional collaboration
- Training and Leadership
- Analytical methods
- Flow cytometry
- Technical training
- Project management
- Data analysis
- Laboratory procedures
- Effective communication
- Operations management
- Results analysis
- Presentations
- Strategic planning
- Public speaking
- Decision-making
- Team building
- Inventory management
- Time management
- Process improvement strategies
- Team collaboration
- Workload management
Certification
- Good Manufacturing Practices (GMP) Certification
- Advanced Flow Cytometry Training (If applicable – specify institution or provider)
- GCP for Clinical Trials Certification
- Certification for project management
Publications
- Combined inhibition of HMGCoA reductase and mitochondrial complex I induces tumor regression of BRAF inhibitor-resistant melanomas.
- The Glutaminase Inhibitor CB-839 (Telaglenastat) Enhances the Antimelanoma Activity of T-Cell–Mediated Immunotherapies
SOAR: Success through Observer, Action, Results
- Completed the SOAR Training Program, gaining tools to foster commitment and accountability. The program enhanced my skills in improving relationships, increasing self-awareness, driving innovation, and boosting employee engagement and retention, strengthening my leadership effectiveness.
References
References available upon request.
Timeline
Associate Manager, CMC-PD/AD
Immatics
06.2024 - Current
Senior Research Associate, Flow Lab-CMC PD/AD
Immatics
12.2019 - Current
Research Assistant II
MD Anderson Cancer Center
09.2018 - 12.2019
Master of Business Administration (MBA) - Management
Western Governors University
Master of Science - Biotechnology
University of Houston-Clearlake
Bachelor of Science - Mathematical Biology
University of Houston