Anamika Banerjee

I am writing to express my interest in senior scientific and leadership roles within analytical development, quality control, or process development. With over 7 years in the pharmaceutical industry, including extensive experience in GMP quality testing, Cell and Gene Therapy (CGT) manufacturing, and over a decade of translational research, I bring a strong foundation in advancing therapeutics and ensuring regulatory compliance.

In my recent roles, I have led teams in developing, validating, and transferring analytical assays for clinical and commercial programs, supported BLA/IND submissions, and driven cross-functional collaborations to meet operational objectives. My expertise spans assay development (ddPCR/qPCR, ELISA, flow cytometry), upstream process development, and data analysis using tools like JMP and SoftMax Pro. Additionally, I have a proven track record of solving complex challenges, streamlining quality systems, and mentoring high-performing teams.

Throughout my career, I have been committed to innovation, regulatory excellence, and improving processes to advance therapeutic development. I would welcome the opportunity to bring my expertise and leadership to your organization

Professional Summary

Highly skilled scientist with over 17 years of diverse experience in the pharmaceutical industry, academic research, and teaching. Expertise in Cell and Gene Therapy (CGT), GMP product testing, analytical assay development, and translational research. Proven leadership in managing teams, driving innovative research, and ensuring regulatory compliance in fast-paced environments. Adept at assay development, upstream process optimization, and data analysis, with a strong commitment to quality and operational excellence.

Key Areas of Expertise

• Pharmaceutical & CGT Expertise: Over 7 years in the pharmaceutical industry, specializing in CGT, GMP testing, and analytical assay development.

• Academic & Translational Research: Over 10 years of research at the University of Pennsylvania, advancing therapeutics for neuropsychiatric and rare diseases.

• Analytical Techniques: Proficient in ddPCR/qPCR, ELISA, Flow Cytometry, immunoassays, confocal microscopy, and quantitative proteomics. Extensive hands-on experience in potency, titer, infectivity, and residual testing for GMP applications.

• Cell Culture & Upstream Development: Expertise in adherent, suspension, and primary cell cultures, with experience in upstream process development and Design of Experiments (DOE).

• Regulatory & Quality Compliance: Strong knowledge of cGxP, FDA, EMA, and ICH guidelines, with experience in QMS management, CAPAs, deviations, OOS, and Change Controls.

• Leadership & Collaboration: Managed and trained cross-functional teams, liaising effectively between departments to streamline processes and meet strategic goals.

Career Achievements

• Spearheaded bioassay development and qualification for gene therapy products, contributing to IND- and BLA-enabling studies.

• Successfully managed quality control programs, ensuring GMP compliance and audit readiness.

• Played a pivotal role in CAR-T therapy upstream production for BLA submissions.

• Led groundbreaking research at UPENN, securing two NIH R01 grants and contributing to high-impact publications.

Professional Experience

Rocket Pharmaceuticals, Cranbury, NJ

Manager-Bioassay-Quality Control (May 2023 – Dec 2024)

• Managed a team of scientists to support GMP lot release and stability testing.

• Validated reference standards and critical reagents.

• Authored QMS documentation and ensured compliance for IND and BLA submissions.

• Led assay transfers and execution for improved quality control processes.

Senior Scientist-Quality Control (May 2021 – May 2023)

• Developed and validated analytical methods for AAV and Lentivirus gene therapy products.

• Authored SOPs and streamlined quality procedures, enhancing GMP compliance.

Janssen Pharmaceuticals, Spring House, PA

CART Scientist (Jan 2020 – May 2021)

• Led LVV production and process development for CAR-T therapy, supporting BLA submissions.

• Executed DOEs and assisted in downstream purification processes.

Merck, Kenilworth, NJ

Principal Scientist (Mar 2019 – Jul 2019)

• Conducted preclinical process development of anti-Her2a biologics in CHO cells.

• Authored key documents, including ELNs and production protocols.

Taxis Pharmaceuticals Inc., Monmouth Junction, NJ

Research Scientist (May 2018 – Feb 2019)

• Developed biochemical assays for antimicrobial drug discovery and IND-enabling studies.

• Contributed to grant and manuscript writing.

University of Pennsylvania (UPENN), Philadelphia, PA

Senior Research Investigator (Jan 2015 – May 2018)

• Investigated neuropsychiatric disease mechanisms and therapeutic targets, resulting in NIH grants.

• Conducted translational studies using patient-derived samples.

Teaching Experience

• Adjunct Lecturer roles in General Chemistry, Neuropharmacology, and Biochemistry at institutions including Middlesex County Community College, Immaculata University, and Hunter College.

I hold a Doctor of Philosophy and a Master of Science in Biochemistry from Hunter College and the Graduate Center, City University of New York. Additionally, I earned a Master of Science in Molecular Biology and Biophysics and a Bachelor of Science in Physiology from the University of Calcutta in India. To complement my formal education, I have pursued continuing education in various specialized areas. This includes a certification in Drug Safety and Pharmacovigilance (150 hours) from Sollers College, NJ, and training in Regulatory Affairs through Duke University School of Medicine. I have also completed courses in Writing in Science from Stanford University Online and Biotech Laws from the University of San Diego Extension, further enhancing my skills in regulatory and scientific communication.