Vijay Kumar Nallani

📌📌 Specialized in developing and optimizing robust, scalable downstream purification processes for drug substances (DS) to enhance product quality, process robustness, and operational efficiency ➡️ Committed to supporting clinical-phase production while ensuring alignment with biopharmaceutical industry standards and regulatory guidelines. ★ Driving and executing downstream process optimization of challenging recombinant proteins via different chromatographic methods for drug development against "Rare Autoimmune Diseases". ★ Leading activities for the transition of processes from development to manufacturing while staying current with advancements in the field and contributing to continuous improvement of process development strategies in CMC. ★ Executing process improvement projects to enhance yield, reduce variability, and improve overall performance while identifying opportunities for optimization and efficiency. ★ Helping with troubleshooting and resolution of technical issues and supporting the ongoing production and DS GMP manufacturing with a good understanding of protein pharmaceuticals and their regulatory guidelines in biopharma CMC.

✅ Streamlined and troubleshooted 5+ protein chemistry and process development methods - cloning, protein engineering (prototyping & mutagenesis), protein expression, inclusion bodies solubilization, refolding, protein purification (using AKTAs/UNICORN - affinity, IEX, SEC, MMC, etc), DS conjugation, protein analysis, assays, stability testing, etc while supporting formulation development within regulatory requirements for clinical trials. ✅ Improved and implemented workflows in lab-scale downstream process development to scale up the DS production at the pilot scale - Redesigned and tested 5+ process development steps to attain a modified method within a short time frame. ✅ Involved in tech transfer - planning and performing experimental and analysis work in-house in collaboration with CDMO/CMO/CRO and external consultants/stakeholders. ✅ Coordinated the maintenance of the infrastructure and in-house equipment needed for protein purification & production. 📌 𝙂𝙖𝙞𝙣𝙚𝙙 𝙥𝙝𝙖𝙧𝙢𝙖𝙘𝙚𝙪𝙩𝙞𝙘𝙖𝙡 𝙙𝙚𝙫𝙚𝙡𝙤𝙥𝙢𝙚𝙣𝙩 𝙨𝙠𝙞𝙡𝙡𝙨: (i) Pharmaceutical manufacturing of protein biologics, and CMC analytics (ii) Cross-functional collaborations with multiple stakeholders/SMEs and companies

✅ Produced, characterized and delivered bespoke protein reagents & required cell cultures (both suspension & adherent - HEK 293, CHO Cell lines) to different scientific research teams/R&D companies to ➡️ support their projects; The protein reagents were mainly used for biochemical/biophysical assays & structure-function studies such as Cryo-EM or other downstream applications. ✅ Simultaneously handled multiple clients' pipeline projects in mammalian protein expression, purification, cell culture and transient transfections/co-transfections (both upstream-& downstream processing) as a part of Protein Production Network, Sweden (PPNS). ✅ Scaled up the production of challenging proteins (including protein complexes using advanced protein tags & antibody purifications); Analyzed, evaluated & reported the data to clients and progressed the portfolio. ✅ Concurrently led a Technology Development Project to identify new possibilities for capability development within the Core Facility by establishing protein quality control (QC) methods (such as analytical SEC/SEC-MALS for protein characterization) & state-of-the-art protein purification methods. 📌 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙚𝙙 𝙘𝙡𝙞𝙚𝙣𝙩-𝙛𝙤𝙘𝙪𝙨𝙨𝙚𝙙 𝙨𝙠𝙞𝙡𝙡𝙨: (i) Simultaneous handling of multiple client pipeline projects (ii) Preparation of SOPs for different protein analytics, risk assessments, deviations, Good Documentation Practice & GSP (iii) Maintaining positive relationships with customers and gaining customer satisfaction, maintenance of customers' project data in the facility's database (iv) Strategic planning & scientific discernment

✅ Thoroughly involved in process/method optimization & development (in membrane protein production) via time- and cost-effective approaches, and scaling up the process following GLP/GMP guidelines ➡️ by extensive troubleshooting/problem-solving. ✅ Co-ordinated and collaborated with other technical/scientific teams that were involved in various activities in upstream/midstream and downstream processing (USP & DSP) in protein production at the company. ✅ Independently (as well as in-team) designed and operated lab/pilot experiments for large-scale native membrane protein production (in grams-scale, via column chromatography including column packing) in an industry perspective. ✅ Efficiently planned, scheduled and monitored project timelines, milestones and deliverables within specific deadlines supporting overall business strategy. ✅ Have a good experience/knowledge in protein quality control (QC) methods such as UV-Vis spectroscopy, dynamic light scattering (DLS), circular dichroism (CD) and mass spectrometry (MS) and other techniques such as HPLC, etc. 📌 𝙂𝙖𝙞𝙣𝙚𝙙 𝙞𝙣𝙙𝙪𝙨𝙩𝙧𝙮 𝙨𝙠𝙞𝙡𝙡𝙨: (i) Process development in large-scale (ii) Business-oriented mindset - linking research to business and bringing a commercial value, product and market knowledge, commercial acumen, understanding industry trends (iii) Flexibility and adaptability to work in a company setting, team working, resilience and right decision making.

✅ Successfully managed an R&D industry project in protein research. Main challenges were: (i) To develop a novel native protein production method in large-scale and (ii) To produce stable, functional and high protein-yielding mutant (engineered) microbial strains using cutting-edge techniques (by directed evolution - random mutagenesis and other state-of-the-art methods). 📌 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙚𝙙 𝙞𝙣𝙙𝙪𝙨𝙩𝙧𝙮 𝙥𝙧𝙤𝙟𝙚𝙘𝙩 𝙢𝙖𝙣𝙖𝙜𝙚𝙢𝙚𝙣𝙩 𝙨𝙠𝙞𝙡𝙡𝙨: (i) Technology transfer to life sciences industry (ii) Engaging in international stakeholder's projects, understanding business objectives/goals, method development, strategic thinking, effectuation (iii) Customer focused mindset, supporting and providing documentation/reports to the CMO/R&D company.

✅ Led an industry-based membrane protein engineering (Directed evolution) project, constructed mutant DNA libraries, and studied gene to structure workflow. ✅ Designed and generated mutation libraries to study structure-function dynamics and screen them for improved activity, stability and functionality. ✅ Achieved the highest recorded yield of purified membrane protein ever reported in yeasts in the scientific literature using any overproduction host. Supplied membrane protein reagents to a biotech company (Golgi ApS, Denmark). ✅ Advanced the development of novel industrially useful microbial strains and actively involved in large-scale membrane protein production (using fermentors) via next generation chromatography/ÄKTA systems (ÄKTA Pure/Explorer/Start using Unicorn Software) - affinity, IMAC, ion-exchange (both Cation & Anion IEX) and gel filtration (size exclusion chromatography, SEC) methods. 📌 𝙂𝙖𝙞𝙣𝙚𝙙 𝙞𝙣𝙙𝙪𝙨𝙩𝙧𝙮-𝙤𝙧𝙞𝙚𝙣𝙩𝙚𝙙 𝙨𝙤𝙛𝙩 𝙨𝙠𝙞𝙡𝙡𝙨: Working on industry projects, international industry collaborations, operating tools and machinery, and effective usage of machine equipment/automated workstations.

✅ Received a Swedish postdoctoral grant of 576000 SEK from Stiftelsen Olle Engkvist Byggmästare (for a research proposal on 'Biophysical and Biochemical Characterization of Signaling Proteins') and also a fellowship from Carl Tryggers foundation. ✅ Established and thoroughly troubleshooted 10+ different biochemical strategies for protein assays and nucleic acid/metal-protein interaction assays in vitro and in vivo (protein pull-down assays, protease susceptibility assays and thiol trapping assays and isolation of DNA-/metal-protein complexes). ✅ Optimized and improved the expression and purification of nearly 10 recombinant proteins/variants (constructed via site-directed mutagenesis) in bacterial and yeast systems. ✅ Designed and formulated novel epigenetic assays in vivo (nucleosomal scanning assays and ChIP/immuno assays) and extensively studied epigenetic regulatory mechanisms. Planned and executed novel methods in the area of molecular microbiology. 📌 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙚𝙙 𝙘𝙤𝙡𝙡𝙖𝙗𝙤𝙧𝙖𝙩𝙞𝙫𝙚 𝙨𝙠𝙞𝙡𝙡𝙨: Working with (5+) cross-functional teams, international academic collaborations, scientific communication, data analysis (as evidenced by 2 first-authored scientific publications), work under pressure and meeting deadlines.

✅ Investigated 5+ metabolic pathways and studied 10+ enzymes/inhibitors/repressors/activators involved. Identified and biochemically characterized novel proteins [via isoelectric focusing (IEF), Western analysis, protein quality control (QC) methods, etc] and analyzed their localization by immunofluorescence microscopy (immuno-cytochemistry). ✅ Explored and conceptualized the mechanisms of gene expression and regulation (via microarray, qPCR/RT-PCR, semi-quantitative PCR, Northern, Southern analyses, DNA footprinting, electrophoretic mobility shift assays, etc). Devised and successfully established a strategy for gene knock out in P. pastoris. 📌 𝙂𝙖𝙞𝙣𝙚𝙙 𝙥𝙧𝙤𝙗𝙡𝙚𝙢 𝙨𝙤𝙡𝙫𝙞𝙣𝙜 𝙨𝙠𝙞𝙡𝙡𝙨: Critical thinking, project planning, execution, conceptualization (with 2 first-authored publications), laboratory research, experimental redesign (for 10+ novel trials/evaluations), simultaneous management of 2 different projects, independent working, designing, devising, optimizing and improving protocols/methods (authored 1 book chapter), scientific writing, presentation, quick-learning and analytical skills.

✅ Instructed, trained and supervised over 500 students (for around 3000 hours) and graded lab reports throughout the 3+ academic years. Taught Biochemistry to B.Sc. (Bachelor of Science) students and organized lectures and designed lab demonstrations to illustrate technical lab/course concepts. ✅ Worked as the Head of the Department (Biochemistry) for a year and succeeded in motivating and fostering students to get 10+ top ranks in the entrance exams of various Indian universities at their Masters level. 📌 𝘿𝙚𝙫𝙚𝙡𝙤𝙥𝙚𝙙 𝙡𝙚𝙖𝙙𝙚𝙧𝙨𝙝𝙞𝙥 𝙨𝙠𝙞𝙡𝙡𝙨: Organizational skills, planning, maintenance of laboratory including lab equipment, lab safety, teaching (1000+ lectures), mentoring, supervising, motivating, influencing others, conflict resolution/management, relationship building, negotiation, diplomacy, time management, work commitment, communication, effective listening, interactive, interpersonal skills and promoting science to a broader audience.

🎯 The goal of my PhD research projects was to identify and characterize the transcription factors/proteins involved in multiple metabolic pathways, which can improve our comprehension of heterologous protein expression in Pichia pastoris, a well-known methylotrophic yeast for the production of recombinant proteins including human subunit vaccines (Received both 𝗣𝗿𝗼𝗳. 𝗚𝗶𝗿𝗶 𝗺𝗲𝗺𝗼𝗿𝗶𝗮𝗹 𝗺𝗲𝗱𝗮𝗹 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗯𝗲𝘀𝘁 𝗣𝗵𝗗 𝘁𝗵𝗲𝘀𝗶𝘀 and 𝗗𝗿. 𝗔.𝗦. 𝗣𝗲𝗿𝘂𝗺𝗮𝗹 𝗮𝘄𝗮𝗿𝗱 from the department).

✦ Specialized in the field of Biochemistry - studied Protein Chemistry, Advances in Molecular Biology, Genetic Engineering, etc.

✦ Apart from studying Chemistry, Botany and Zoology subjects, qualified in an NIIT (National Institute of Information Technology) certified program.