Arindam Basu, Phd, Dipwset Email & Phone Number

King Of Prussia, Pennsylvania, United States

• Overseeing lab activities and assays execution of junior members of the team and mentoring them.• Execution of testing in development laboratory.• Collaborate with a diverse team to execute assays for cell and gene therapy applications.• Design and conduct cell-based and molecular assays for gene & cell therapy products. • Generate, analyze, and record data using electronic documentation, and database tools.• Maintain laboratory records and contribute to laboratory organization and maintenance.• Independently execute analytical methods to characterize viral vector and cell therapy products.• Perform analytical testing in support of process development, cGMP investigations and product characterization.• Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams.

Philadelphia, Pennsylvania, United States

• Demonstrated a thorough understanding of GxP and regulatory guidelines and requirements for GLP and IND studies in collaboration with sponsors.• Led development and qualification of GC titer assays using Poly A targets, analysis of biodistribution of viral vectors in rodents and non-human primates (NHP).• Oversaw testing under research and GLP/GMP environments with QA oversight. Interacted with three internal and external sponsors and CDMOs for procurement of source material and testing. Coordinated extensively with Sample Management for smooth functioning of lab operations. • Developed robust training programs for 5 operators and ensured proper documentation and lab workflow following GxP guidelines. • Participated in implementation of new methods and establishment of automation technology (Hamilton) that is currently being qualified for GLP testing. • Instrumental in authoring and reviewing technical reports, SOPs, test / batch records, qualification reports and relevant sections of regulatory submissions.

Philadelphia, Pennsylvania, United States

• Provided training and guidance to four associate scientists and several technicians across five “buckets”. • Oversaw assay / method development and optimization of reference standards for increased testing efficiencies.• Ensured initiation and completion of non-compliance items such as laboratory investigation, NCE, CAPA in conjunction with client requirements. • Provided scientific expertise to other “buckets” such as residual, genomic stability, sequencing.• Oversaw preparation of technical documents (CoA, CoT, R&D reports, VP, QP reports) and performance of testing in accordance with company SOPs, GxPs, ICH and 21 CFR Part 11.

Philadelphia, Pennsylvania, United States

• Conducted and directed assays and lab procedures in compliance with cGMP, CFR and SOPs. • Provided accurate completion of batch records and required documentation in adherence with SOPs. • As Technical Reviewer, demonstrated scientific expertise to conduct critical review of results and data reporting as well as initiated, prepared and revised technical documents, and SOPs.• Provided training to new personnel on issues relevant to the lab operations.• Interacted with clients to address scientific and technical issues as well as non-compliance documents. • Contributed to overall departmental goals by performing job specific tasks in compliance with regulatory guidelines, international standards, SOPs, and WuXi AppTec policies.

Media, Pennsylvania

• Taught undergraduate courses including Human Anatomy & Physiology, Introductory Biology (writing course), Bioinformatics, as well as the labs associated with these courses. • Explained complex concepts in a clear, easily understood manner and provided students with hands-on learning opportunities.• Participated in lab meetings (with undergraduate research students), seminars, and committees to share information regarding best practices in research.• Supervised undergraduate student-driven research focused on genome wide binding of transcription factors, Polycomb proteins, and chromatin modulators.• Guided students in writing accurate, articulate articles presenting their research findings; instructed on how to maintain detailed records on experimental setup and follow good GLP practices; empowered students to serve as first author or significant contributor on publications. • Engaged in scientific writing leading to multiple publications as well as regional and international presentations.

Philadelphia, Pennsylvania

• Performed experiments focused on B-cell biology and Polycomb proteins. • Explored DNA-protein interactions using ChIP-seq, 3C assays, CoIP, EMSA, yeast two-hybrid and other techniques. • Was involved in antibody generation, transduction of splenic B cells and bone marrow cells with retro viral vectors for overexpression of proteins for downstream biochemical assays.• Led student-driven research projects as part of their undergraduate degree. • Collaborated with faculty, post-docs, and students on projects.

Philadelphia, Pennsylvania

• Initiated and established ChIP-seq, RNA-seq, and microarray protocols resulting in publications.• Established PCR-based immunoglobulin gene rearrangement assays in pro- and pre-B cells.• Orchestrated pioneering work in epigenetics involving Polycomb recruitment to DNA by using ChIP, co-IP, and yeast two-hybrid methods leading to 4 publications.• Initiated studies with small peptides for use as therapeutic target in cancer cell lines.• Established SELEX studies to determine novel DNA binding sequence of transcription factors.• Generated and established transgenic Drosophila lines for genetic and biochemical assays.

Doctor Of Philosophy - Phd, Biochemistry And Molecular Biology (Gene Regulation)

Thesis: Insights into Transcriptional Regulation of the receptor Guanylyl Cyclase C gene: Role of HNF4, COUP-TFs, and GATA-6 transcription.

Master Of Science - Ms, Biotechnology

Dissertation: Decolorization of textile mill effluents using the fungus, Aspergillus foetidus.

Bachelor Of Science - B.Sc., Human Physiology

Level 4: Diploma In Wines

Certified Specialist Of Wine

Level 1 Sake, Wine Steward/Sommelier

Certified Sherry Wine Scholar (Csws), Wine Steward/Sommelier, Highest Honors