Summary
Overview
Work History
Education
Skills
Additional Information
Timeline
Generic

Debojyoti Lahiri

Morrisville,NC

Summary

Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. 12 years of post-Ph.D. oncology and molecular biology experience in designing and performing cell based bioassays, monoclonal antibody discovery and development, with hands on experience on leading students and team of scientists on different projects involving protein quantitation and purification, genetic screens, electrophoretic and column chromatographic techniques in protein analysis, biochemical techniques such as qPCR, HPLC, DNA sequencing, SDS-PAGE, CE, Densitometry and various immunoassays such as ELISA, IP, IF etc. in cGMP. Experienced with inter-organizational collaboration, investigations and authoring standard operating procedures (SOP). Well-organized, Motivated, and hardworking individual with good communication skills and efficient in deviation processes.

Overview

13
13
years of professional experience

Work History

Manager- QC Method Transfer and Validation

Pfizer
04.2023 - Current
  • Mentored a team of 6 members for career advancement, fostering a pipeline of future leaders within the organization.
  • Established robust risk mitigation strategies to safeguard against potential validation challenges or product testing disruptions.
  • Drove operational efficiency through data-driven decision-making processes, leveraging analytics tools for informed strategy development.
  • Implemented effective method transfer and validation scheduling strategies that facilitated the acquisition of a $37M asset within 10 months.
  • Cultivated strong partnerships with external stakeholders to optimize the business opportunities and extend network reach within the organizational divisions.
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Facilitated successful cross-functional collaborations among different groups for the successful completion of 2 CTM campaigns, and 1 marketed product, fostering strong working relationships among team members and across the groups.
  • Achieved departmental and site goals by developing and executing strategic plans and performance metrics.
  • Ensured meeting cross-site deliverables satisfactorily by resolving investigations and implementing CAPA (Corrective And Preventive Actions) promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
  • Streamlined training and method workflows by identifying bottlenecks in existing SOPs and proactively addressing the challenges through appropriate solutions implementation.
  • Onboarded new employees with training and new hire documentation.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Cross-trained existing employees to maximize team agility and performance.

Manager/Associate Director

Locus Biosciences
04.2022 - 03.2023
  • Supervised a team of three (3), reviewed their work and reports the workflow status and the performances to the management.
  • Environmental monitoring through plates, Microbiological assays like endotoxin assays, potency assays etc.
  • Helped building up a new Analytical Development Team along with the Director and the team.
  • Successes: a) Three Drug Products (Phase I, Phase II/III) assay development, analyses, method development and method qualification has been brough inhouse from the external vendors in last 5 months. b) $1.5M project brought in-house with method validation and qualification in 2 months working along with the team.
  • Reported and present the project status, issues, and Risks to the team and upper management and outside partners.
  • Got routinely involved in the teamwork to mitigate the risks and issues faced by the project and the team to come up with a resolution.

Project Leader

Thermo Fisher Scientific, Patheon
08.2021 - 04.2022
  • Consulted with internal scientific, analytical, and laboratory functional areas to meet project and team objectives. Performs all duties in strict compliance with ICH guidelines, cGMP practices, Standard Operating Procedures, Good Laboratory Practices and Safety guidelines.
  • Guided and advised during implementation of new methodologies and processes.
  • Managed the project status and progress working with supervision in the analytical development part.
  • Investigated, created, and validated new scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of projects.
  • Managed regulatory issues, maintain submission information in relevant GCMC systems, track regulatory commitments & timelines for projects.
  • Developed realistic proposals and timelines.
  • Leaded meetings/teleconferences with clients.
  • Leaded projects without supervision; leaded multiple projects, including managing project timelines and deliverables.
  • Involved in pre-clinical, clinical, and/or post-marketing stages of drug development.
  • Worked on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations.
  • Testing for large molecules of biological origin for methods associated with identity, potency, and purity testing.
  • Participated in technical discussions with clients with a high level of technical proficiency.
  • Engaged in creation of processes for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients.
  • Evaluated and contributed to support problem solving as necessary with independent judgment.
  • Worked in a specific scientific area of analytical development, process validation, formulations, and manufacturing technical support.
  • Made decisions that require developing new options to solve complex problems.
  • Coordinated development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
  • Coordinated research of industry practices and processes and apply to innovative drug development internally and for client products.
  • Presented recommendations internally and to clients.
  • Maintained the necessary compliance status required by company and facility standards

Senior Scientist

Eurofins Lancaster Laboratories PSS
09.2018 - 07.2021
  • Contributed in large number of analytical assays and SEC-MALLS method development for emerging and established vaccines from leading pharmaceutical company as a client.
  • Obtained client satisfaction recognition for teamwork and working in collaboration with other colleagues.
  • Contributed in an investigation regarding the leachable material in the polysaccharide-protein conjugates from the silicone tubing and bagging materials.
  • In-charge of training newly recruited scientists.
  • Wet-chemistry and instrumental analytical chemistry analyses on in-process and final batch/bulk concentrates sample types and preparation of the analytical standards and reagents.
  • Protein purification process development (using techniques such as TFF, Chromatography, ultrafiltration, diafiltration)
  • Operated and maintained laboratory equipment and instruments.
  • Data Analysis and reporting results to the internal and external teams.
  • Maintained electronic lab notebooks (i.e. Biovia eLN) and process data accordingly (i.e. Excel, Sample submission and management etc).
  • Documentation and review of the data from the method development analysis.
  • Author, review, and approve technical reports, methods, and regulatory documents which expresses excellent communication (oral and written) skill and attention to detail.
  • Coordinate with team members to ensure seamless coverage during manufacturing campaigns. Support new project activities, as needed.
  • Work with strong leadership, initiative, and teambuilding skills.
  • Able to work individually as well as support colleagues on various projects as assigned.
  • Served on various teams as analytical representative and/or subject matter expert.
  • Performed general administrative assignments showing strong computer, scientific, and organizational skills.
  • Perform method development and method transfer in support of various projects.
  • Took personal responsibility to meet deadlines, as well as safety and training requirements.

Clinical Scientist

Pfizer
01.2018 - 09.2018
  • Large molecule end product development such as Liraglutide.
  • Performed testing using analytical equipment (i.e. UPLC, HPLC, GC, Karl Fischer, pH, UV-Vis, IR, microscopy, optical rotation) as well as using traditional wet chemistry methods (i.e. titration, TLC, sulfated ash, etc.)
  • Entered experimental information into hard-bound and electronic lab notebooks (i.e. Biovia eLN) and process analytical data accordingly (i.e. Empower 3,Excel, etc).
  • Performed additional data entry, processing, and review within LIMS system (i.e. Thermo LIMS).
  • Coordinated with team members to ensure seamless analytical coverage during manufacturing campaigns and on-going stability studies. Supported new project activities, as needed.
  • Developed analytical method feasibility, and validation, as necessary.
  • Coordinated with team members to verify each other’s data by reviewing eLN and LIMS entries in a timely manner.
  • Authored protocols, reports, or other technical documents, and presents project data to group, as needed.

Adjunct Faculty Member

Durham Technical Community College
08.2017 - 12.2019
  • Teaching Organic Chemistry 251 Course to a class with strength of 25 students.
  • Laboratory instruction and supervision.

Postdoctoral Researcher

North Carolina State University
04.2015 - 12.2017
  • Presented research findings at international conferences, fostering knowledge exchange among peers and collaboration with universities such as UNC and UVA with proven expertise in cancer biology cell culture experiments, monoclonal antibody discovery and development, with hands on experience on aseptic techniques, genetic screens, electrophoretic and chromatographic techniques in protein analysis, biochemical techniques such as qPCR, HPLC, DNA sequencing, SDS-PAGE, CE, Densitometry and various immunoassays such as ELISA, IP, IFetc.
  • Optimized laboratory processes to ensure accurate results and efficient use of resources.
  • Mentored junior graduate students, postdoctoral research associate and project trainees, enhancing their skills and supporting their career development in a GLP environment.
  • Streamlined data management practices for easier access and improved collaboration among team members.

Postdoctoral Researcher

University Of Virginia, School Of Medicine
06.2011 - 03.2015
  • Helped secure research grants amounting to over $700,000.
  • Identified and characterized the unusual role of a molecular checkpoint protein Mad1 in prevention of cancerous cell division on yeast and mammalian cells.
  • Analyzed potency of the carcinogenic small molecules on cell division.
  • Developed cell culture experiment protocol to study the effect of drugs on cellular life cycles with the help of Flow cytometry.
  • Purification of antibodies for phospho-proteins and GFP such as phospho-Mad1, involved in cancer malignancy and studying kinases such as ATR and ATM.
  • Supervised and trained the undergraduates and project trainees.
  • Performed assays such as Ligand binding assays, Protein A ELISA, HCP ELISA, RP- HPLC, and UV-Vis (Mass Spec.)
  • Identified gaps in equipment maintenance, procedures and laboratory practices.
  • Authored, performed and reviewed robustness studies, and write final reports.

Education

Ph.D. - BioInorganic Chemistry

Indian Institute of Science
Bengaluru, KA, India
12.2010

Master of Science - Inorganic Chemistry

University of Calcutta
Kolkata, WB, India
06.2004

Skills

  • Strategic Planning
  • Contract Management
  • Workforce Management
  • Performance Management
  • Multitasking Abilities
  • Performance Tracking and Evaluation
  • Team Leadership
  • Cross-Functional Teamwork
  • Preventive Maintenance
  • Time Management
  • Employee Development
  • Task Delegation

Additional Information

Knowledge

· Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), Good Manufacturing Practices (GMPs)

· Validation protocols and reports, analytical test procedures, technical reports, and change controls Equipment Validation

· Cell Culture, Aseptic Technique

· Potentiometry,

· Assay Data Review

· Method qualification/validation

· Karl Fischer Titration

· GC/MS, LC/MS

· Knowledge of FDA, EPA, ICH requirements

· Read, Edit and Create Standard Operating Procedures (SOPs)

· Light Scattering, Micro-Flow Imaging

· Capillary Electrophoresis

Methods/Instrumentation

ELISA/ EIA, BioTek Eon Plate Reader

∙ Fluorometric Spectroscopy

DNA, RNA and Protein purification

SEC-MALLS

R, Origin Pro, Graph Pad Prism

Protein purification

∙ Medicinal chemistry, biochemistry,Molecular biology and genetics

∙ Capillary electrophoresis Beckman Coulter System

∙ Ligand Binding Assay

qPCR, RT PCR (StepOne)

∙ Waters HPLC

∙ Cellular imaging

∙ BD flow cytometer

∙ CCD X-ray diffractometer

∙ Maldi-TOF MS

Immunoassays MTT, Immunoblotting, IF, IP

FTIR, UV Spectroscopy

∙ NMR

∙ Cell Based Bioassay

∙ Fermenters/Bioreactors

∙ Technical reports and scientific journal publications and presentation

∙ Wet chemistry and molecular synthesis

∙ Capillary electrophoresis Beckman Coulter System

∙ DNA binding, DNA melting, viscometry, cyclic voltammetry,

Skills

∙Analysis of leachable and extractable materials from Silicone tubing and bagging ∙Wet chemistry and molecular synthesis ∙Osmolality ∙Bioconjugation chemistry ∙Ligand Binding assay ∙Scientific writing and publishing in top international peer reviewed journals ∙X-ray Crystallography ∙FT-IR ∙UV-Visible ∙Fluorescence ∙EPR ∙NMR ∙ESI ∙MALDI-TOF MS spectroscopy ∙Magnetism ∙Electrochemistry ∙Molecular modeling ∙Theoretical calculation of energy minimization ∙HPLC (reverse phase, IEC, SEC) Empower 3 ∙Capillary electrophoresis ∙DNA, and RNA purification ∙Mammalian cell culture and probiotics such as Yeast ∙in vitrocytotoxicity ∙Microscopy and Cellular imaging ∙MTT assay ∙ELISA ∙MSD-ECL immunoassay ∙LASER assisted DNA cleavage ∙DNA binding ∙DNA melting ∙Viscosity studies ∙pH meter ∙Recombinant protein/mAb analysis purification and storageImmunoprecipitationImmunofluorescenceImmunoblotting ∙Agarose gel electrophoresis and SDS PAGE ∙Flow Cytometry ∙FACS ∙Monoclonal antibody purification and engineering ∙DNA manipulation and site directed mutagenesis ∙DNA sequence analysis ∙PCR amplification ∙cloning ∙RT-PCRand qPCRAntibody Development and purification ∙Circular Dichroism, ∙Fluorescence ∙Differential Scanning Calorimetry ∙ Image J and Graph Pad Prism


Awards, Affiliations and Hobbies

● 2019-2021 – 4 “Inspire” awards, 4 “Impact” awards and one “Living Our Values” and one “Superlative Service” award from Eurofins.

● 2010 - Awarded Post-doctoral fellowship from Department of Biotechnology (India).

● 2006 - Awarded Senior Research Fellowship (SRF) by Indian Institute of Science, Bangalore, India.

● 2004 - Awarded Junior Research Fellowship (JRF) by Indian Institute of Science, Bangalore, India.

● 2004 - Qualified in National Eligibility Test (NET) (CSIR), India for pursuing lecturership at the national level.

● 2004 - Qualified in the Graduate Aptitude Test in Engineering (GATE), for pursuing doctoral degree at the national level.

● Scientific reading and writing, science communication.

● Published photographer in National Geographic Society, BBC, and Discovery, Lonely planet and Outdoor Photographer.

Timeline

Manager- QC Method Transfer and Validation

Pfizer
04.2023 - Current

Manager/Associate Director

Locus Biosciences
04.2022 - 03.2023

Project Leader

Thermo Fisher Scientific, Patheon
08.2021 - 04.2022

Senior Scientist

Eurofins Lancaster Laboratories PSS
09.2018 - 07.2021

Clinical Scientist

Pfizer
01.2018 - 09.2018

Adjunct Faculty Member

Durham Technical Community College
08.2017 - 12.2019

Postdoctoral Researcher

North Carolina State University
04.2015 - 12.2017

Postdoctoral Researcher

University Of Virginia, School Of Medicine
06.2011 - 03.2015

Ph.D. - BioInorganic Chemistry

Indian Institute of Science

Master of Science - Inorganic Chemistry

University of Calcutta
Debojyoti Lahiri