Archna Gautam
Qc Manager @Johnson & Johnson
Signup · Get unlimited contacts
WORK HISTORY
Qc Manager @Johnson & Johnson
Malvern, PA, US
Built and expanded a team from five (5) to thirty (30) members within two years, nowleading operations across two sites in Malvern and Spring House, PA. Led Malvern CRS lab operations, ensuring the compliant supply of CAR-T productsthrough strategic leadership and operational oversight. Established Stability Program for new modalities Oversaw new product introductions via the Analytical Development team, ensuring timelycompletion of project deliverables. Oversaw Quality Control for various cell and gene therapies, ensuring GMP complianceand accurate test execution. Successfully led FDA, TGA, and IJG audits with NO major findings. Managed supervisors, scheduling, and resource planning for new modalities. Onboarded and led the ELM team to support cell and gene therapy products. Spearheaded digital initiatives for full LME (100% paperless) adoption by 2025. Approved documents and ensured accurate analytical method transfers. Communicated KPIs and key metrics to staff and Sr. leadership team. Developed streamlined processes for capacity assessments, resource and projectplanning to support newer modalities efficiently. Provided oversight to ensure timely completion of laboratory investigations, includingOOS/Invalid assays, CAPAs, and change controls.
EDUCATION
Kurukshetra University
MS, Plant Molecular Biology
Wayne State University
MS, Molecular Biotechnology
Kurukshetra University
Bachelors, Chemistry
SKILLS
ABOUT ARCHNA GAUTAM
Currently seeking new opportunities in South-East Pennsylvania.High-energy and innovative professional with broad experience in stem-cell research, molecular techniques, cell culture, protein expression, and a strong background in biotechnology. Currently seeking career advancement opportunities in biotechnology.Specialties: • ES Cell Culture - Maintenance and Differentiation•Flow Cytometry (FACS), FlowJo and FACSDiva software•Hands-on experience with FACS Calibur, FACS Celesta, LSRII, LSR Fortessa and Guava PCA-96,•Transfections and ELISA.•Plasmid Isolation, PCR techniques, Primer design, BLAST, PDB, DNA/RNA extraction•Protein expression and purification, vector construction, molecular cloning, Immunology techniques, Polyacrylamide Gel Electrophoresis, Western Blotting, In-situ hybridization•Immuno-blotting, Histological techniques, Restriction enzyme digestion, Purification and Characterization of Antibodies•Advanced FACS training from BD Biosciences
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.