Abhisekh Singh

• Developing and validating Mass spectrometric methods using top-down and bottom-up proteomics intended for characterization of therapeutic antibodies, bi-specific antibodies, peptides and antibody-drug conjugates.
• In charge of developing novel mass spectrometer-compatible chromatography techniques such as SEC, IEX and HIC.
• Responsible for training junior scientists and interns on executing and troubleshooting mass spectrometric methods.
• Currently supervising installation, IQ, PQ and OQ of Thermo Eclipse Tribid Mass Spectrometer coupled to Vanquish Neo Nano-LC.

• Headed a team of 4 to develop a protein purification process by screening different agents and conditions to induce large-scale crystallization of biologics in an attempt to replace protein A chromatography.
• Received appreciation from external clients for developing a small-scale crystallization process for a therapeutic peptide intended for animal studies.
• Worked individually and developed ultra-high concentration low-viscosity protein formulations for biologics and designed experiments to screen different excipients that lower viscosity intended for SC administration instead of IV.
• Developed HPLC and CE-SDS analytical methods to characterize crystallized and ultra-high concentrated therapeutic antibodies for compatibility and stability purposes.
• Trained Junior research assistants and scientists on HPLC method development and validation.
  scientists on HPLC method development and validation.

• Promoted to senior scientist in July 2018.
• Designed, developed and qualified LC-MS methods in cGMP environment and generated quality data leading to successful dossier submission for first FDA and EMEA approved Trastuzumab bio-similar -OGIVRI.
• Provided LC-MS data as part of BLA submission package for EMEA & TGA approved Bevazicumab bio-similar Abevmy, FDA & EMEA approved PEG-GCSF bio-similar FULPHILA , DCGI approved Alzumab (Itolizumab) and as part of IND/NDA filing for Novel Fusion mAb (under early-stage development).
• An expert in operation, maintenance and calibration of state of the art high-resolution mass spectrometers and HPLC/UPLC/UHPLCs from Thermo scientific, Bruker, Shimadzu, Agilent and Waters and its relevant data analysis software.
• Supervised daily analysis and maintenance activities run on LC-MS instruments in the lab and coordinated with the team and service engineers to quickly resolve issues which led to more than 50% reduction in downtime.
• Resolved challenges arising from development and execution of chromatographic techniques (SEC, RP, HIC, NP, IEX and HILIC) as a part of lot release/routine analysis for bio-similars in cGMP environment.
• Generated product purity data as a part of COGS study using CE-SDS techniques (Reduced and Non-reduced) in mAb In-process samples including data analysis and interpretation.
• Involved in cross functional activities providing scientific support to molecular biology, upstream process, downstream process and drug formulation teams for impurity profiling, clone selection, process optimization activities and controlled forced degradation studies.
• Proficient in development of HOS Techniques employing UV, Fluorescence, Circular Di-chroism and FT-IR spectrophotometer for structure elucidation of bio-similar antibodies and insulin analogues.
• Delivered support in preparation of CTD module 3 dossier section/regulatory documents relating to product characterization and improved analytical techniques and instrumentation SOPs.
• Handled Labware LIMS-eLN deployment and implementation activity intended for laboratory resources management and recording of experimental details and successfully completed the activity in six months.
• Sound knowledge on ICH guidelines, Research quality assurance, GMP, GLP, GDP and GAMP 5 regulations.

• Trained in analytical techniques employing mass spectrometry, HPLC, Circular Dichroism and FT-IR to establish bio-similar activities of insulin and GLP Analogues.
• Received appreciation for working independently with minimal supervision and was offered full-time employment within 2 months of internship.

• Developed marketing content such as blogs, promotional materials and advertisements for social media.
• Maintained company website and was in-charge of pricing for our products including smartphones and its accessories available online.
• Analyzed and reported social media and online marketing campaign results.

• Supervised products including smartphones displays to feature new products and promotions.
• Oversaw the hiring process for new staff associates and trained them in customer service and company procedures.
• Maintained positive customer relationships, facilities, stock, supplies, inventories and accounts.

• Worked as a fundraiser for Cancer Research UK and inspired local people to support the charity by encouraging them to be part of making a real difference to several cancer patients’ lives.

• Sorted letters and packages into various categories during the busy Christmas period. Improved organisational and problem solving skills to speed up the sorting making the mails available for delivery.

• Developed excellent time-management and organizational skills by managing 8 team members in the food service department during the Christmas functions. I persuaded my team members to execute all tasks ahead of deadlines.