Haramritpreet Kaur

Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management

• Work independently, taking ownership of projects and self-managing work packages with appropriate communication and partner concern.

• Plan, design, execute and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management.

• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management

• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software

• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements

• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions

• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs

• Assisted in the development and qualification of analytical assays for the characterization of AAV vectors.
• Identified protein receptors responsible for AAV transport through in vitro methods.
• Performed protein-coated microarrays for the detection of AAV receptor binding.
• Independently and/or under a scientific lead, design and develop analytical assays for testing and characterization of viral vectors.
• Tested vectors from various stages of development and production to support process development, product characterization, and product release.
• Assisted in generating design of experiments, qualify and validate analytical test methods, including supporting documentation, protocols, reports, etc.
• Organized GMP documentations like Batch records.
• Understanding of GMP and regulatory requirements for cell therapy manufacturing and Quality Control.
• Upstream process knowledge and hands on cell culture experience with regard to biological drug substance.

• Hands-on experience in cell cultures, aseptic techniques, cleaning and set up of processing equipment.
• Performed molecular biology techniques like qRT-PCR to analyse mRNA Expression, TCID 50 in the samples.
• Prepared buffers, medias, stock solutions per defined appropriate procedural and documentation procedures like MPs and SOPs and including industry standard good laboratory practice (GLP).
• Conducted Literature review for supporting research objectives.
• Kept detailed records of procedures and findings in the electronic books (benchling).
• Contributed in maintaining lab equipment, consumables inventory and raw materials.
• Provided training on laboratory techniques and product protocols to other staff.

• Maintained and monitored cell quality of patient derived iPSC cell line and differentiated cells.
• Investigated brain disorder project titled "Modeling of Neuronal Ceroid Lipofuscinosis, Type VI in iPSC-derived I3N-neurons.
• Executed the differentiation of induced pluripotent stem cells (iPSCs) into I3N-neurons.
• Established Nile Red positive lipid storage material as a biomarker for CLN6 therapeutic screens.
• Performed immunostaining on I3N-Neurons and analysed them under immunofluorescence microscopy.
• Executed experiments and troubleshooted them independently.
• Analyzed data, interpret results using GraphPad Prism, Image J.

• Designed and planned experimental protocols, prepared poster presentation.
• Participated in preparing media and culture broths for microbial growth.
• Isolated Lactobacillus acidophilus from raw and pasteurized milk.
• Performed Biochemical analysis to identify and confirm the bacterial strain.
• Examined Bacteriocin production from isolated bacterial strain and its Optimization under different physiological conditions.
• Demonstrated antimicrobial activity of Bacteriocin against different pathogens.
• Operated and maintained lab equipment including centrifuges and cytometers.