SHANIL SANTANA
Lodi,NJ
Summary
Results-driven scientist with expertise in cell and gene therapy, aseptic processing, and analytical testing. Known for rapidly mastering new techniques and contributing to cross-functional teams. Seeking to leverage technical leadership to advance scalable, compliant biopharmaceutical manufacturing for life-saving therapies.
Overview
6
6
years of professional experience
Work History
Invitro Scientist
Product Safety Labs
Dayton, NJ
05.2025 - Current
- Design and execute in vitro cytotoxicity studies to evaluate compound safety and efficacy.
- Conduct flow cytometry-based killing assays, LDH release assays, and viability staining under GLP conditions.
- Monitor experimental workflows (cell thawing, seeding, treatment, harvest) to ensure successful 24–72 hr readouts.
- Troubleshoot study deviations (e.g., reagent lot variability, unexpected cell death) by adjusting protocols and validating new materials.
- Perform root cause investigations and document findings in deviation reports; collaborate with QA for CAPA implementation.
Scientist/Engineer – MSAT (Manufacturing Sciences and Technology)
Minaris Regenerative Medicine
Allendale, NJ
11.2022 - 05.2025
- Supported late-stage CAR-T therapy development and GMP-compliant manufacturing processes.
- Designed and executed process development experiments to optimize cell therapy workflows for scale-up.
- Performed analytical testing and prepared lab equipment to support client-specific manufacturing projects.
- Authored key documentation including protocols, development reports, and draft batch records.
- Led root cause analysis and managed deviation/CAPA investigations to maintain regulatory compliance.
- Collaborated with cross-functional teams to ensure seamless technology transfer into GMP manufacturing.
Associate Scientist – Cell Line Development
Bristol Myers Squibb
New Brunswick, NJ
05.2022 - 11.2022
- Performed mammalian cell line development for monoclonal antibody production.
- Conducted transfections, single-cell cloning, and selection of high-producing clonal lines.
- Managed tech transfer for cell banking, testing, and early-stage manufacturing.
- Generated and documented experimental data in accordance with R&D standards for decision-making.
- Supported upstream development of cell lines for clinical and commercial programs.
Cell Therapy Specialist II – Project Lead & Trainer
Minaris Regenerative Medicine
Allendale, NJ
07.2021 - 05.2022
- Led operational improvements and training for CAR-T manufacturing workflows.
- Oversaw optimization projects to enhance scalability, yield, and efficiency.
- Facilitated technology transfer into GMP suites and developed supporting documentation (SOPs, batch records).
- Performed process data analysis using statistical tools (e.g., JMP) to support continuous improvement.
- Trained new personnel on aseptic technique and cell culture procedures under cGMP.
Cell Therapy Specialist I
Minaris Regenerative Medicine
Allendale, NJ
02.2020 - 07.2021
- Supported clinical-scale CAR-T production in ISO 5 & 7 cleanroom environments.
- Performed aseptic processing, cell expansion, and cryopreservation following GMP protocols.
- Operated advanced cell processing platforms (Sepax C-Pro, Lovo Cell, G-Rex, CliniMACS).
- Partnered with QA and compliance teams to investigate deviations and ensure process integrity.
- Assisted in refining CAR-T manufacturing workflows to reduce variability and increase output.
Education
Bachelor of Arts - Biology
Kean University
Union, NJ05-2017
Skills
- Core Technical Expertise
GMP Cell Culture & Expansion, Aseptic Processing (ISO 5/7), Cryopreservation, CAR-T Manufacturing Workflows, Transfection & Single-Cell Cloning, Flow Cytometry, PCR, ELISA, Western Blotting, Viability & Potency Assays
Process Development & GMP OperationsProcess Optimization & Scale-Up, Technology Transfer, Deviation Investigation & CAPA, Validation Support, Batch Record Review, Cleanroom Operations, Root Cause Analysis
Equipment & Manufacturing PlatformsCliniMACS, Sepax C-Pro, Lovo Cell Processing System, G-Rex Bioreactors, Wave Bioreactor, Rocker Bioreactor, Plate Readers
Data & SystemsJMP, Minitab, ELN, LIMS, Microsoft Excel (Data Analysis), Documentation & SOP Authoring
Leadership & CollaborationCross-Functional Collaboration, Project Leadership, Training & Onboarding, Technical Documentation
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Timeline
Invitro Scientist
Product Safety Labs
05.2025 - Current
Scientist/Engineer – MSAT (Manufacturing Sciences and Technology)
Minaris Regenerative Medicine
11.2022 - 05.2025
Associate Scientist – Cell Line Development
Bristol Myers Squibb
05.2022 - 11.2022
Cell Therapy Specialist II – Project Lead & Trainer
Minaris Regenerative Medicine
07.2021 - 05.2022
Cell Therapy Specialist I
Minaris Regenerative Medicine
02.2020 - 07.2021
Bachelor of Arts - Biology
Kean University