Anurag Parihar, PhD, PMP

- CMC Strategy and Project Management - CMC Analytical Sciences - Analytical methods (physchem and potency) development and validation - Process development, characterisation and validation - CDMO oversight and management -Analytical method transfers - DS and DP release and stability testing strategy development -Product characterisation - In-process analytics for process development, characterisation, validation and monitoring - Reference standard manufacture, qualification and stability - IND/IMPD and BLA/MAA module 3/Quality module authoring - Regulatory compliance strategy development -Product comparability assessments - OOS and RCA investigation lead

- CMC analytical strategy for biologics (recombinant, vaccines,and cell & gene therapy) - Project Management and regulatory compliance - Overseeing and leading outsourced analytics for Phase 3 and Commercial manufacture - Contributing to the preparation of high quality regulatory dossier for clinical trial and marketing applications in US, EU, UK, Canada and Australia. - Leading (as Scrum Master) research and early development Agile and hybrid recombinant therapeutic project to shorten product development timeline - Leading analytical method development and validation (product and process specific methods) - Leading interim and commercial reference standard strategy including stability testing - Leading phase appropriate and patient centric product comparability studies - Proficient in ICH, FDA and EMA regulations - Leading CMC analytics for advancing projects from preclinical to early (Phase 1 and 2) and late stage clinical studies (Phase 3) - Leading technical transfer of bioanalytical methods to contract testing labs.

- Led cross-functional project teams with global stakeholders (AU, EU, US) to advance the projects from discovery and PoC studies to GLP Tox and clinic (Phase 1) - Supported R&D executives in planning and prioritisation of resources, capital, and projects. - Facilitated development of corporate objectives with Functional, Therapeutic Area, Commercial, CMC and Global Platform leads. - Managed project outsourcing, licensing, IP, external collaboration, legal and contractual activities. - Developed project charter, plans, project governance proposals and composed project progress, quality and budget reports for executives and senior management. - Led projects from multiple therapeutic areas with different modalities (recombinant, plasma, gene therapy) - Planned and monitored project schedule, scope and budget including >$1 million external expenses. - Collaborated with Functional leads and SMEs to monitor project progress, risks and quality for research and early development. - Co-led analytical and characterisation strategy development and determination of candidate drug target profile (CDTP) and QTPP elements.

- Collaborated with clients from upstream, downstream, bioanalytics, characterisation and manufacturing and CMC to facilitate drug development - Led cross-functional digital innovation within the business unit - Enabled data-driven decision making for clients and stakeholders through Python based data wrangling, analysis, and visualisation. - Co-led development, deployment and maintenance of automation platforms for bioanalytics - Devised mass spectrometry-based characterization strategy (top-down and bottom-up) for supporting recombinant product development from discovery to clinic - Developed QqTOF, Orbitrap and triple quadrupole-based methods for recombinant product characterisation

- Performed liquid chromatography mass spec based routine and extended characterisation (HCP, sequence variant, peak ID) of recombinant proteins to support clients from process development, pilot scale operations, technical transfer, and bioanalytical teams. - Optimised peptide mapping and subunits analysis methods for routine characterisation. - Streamlined data reporting workflows and SOPs for peptide mapping and subunits analysis. - Supported product development projects from Phase I to Phase III and providing characterisation information for dossier submission. - Performed mass spec based characterisation assays to assist process development and analytical method development teams.

•Demonstrated commercial acumen by liaising with industry partner to develop a catalytic process for waste and biomass conversion to green chemicals like substituted furans and levoglucosenone that resulted in a provisional patent, more than 6 technical presentations, 4 publications (1 published, 3 under review) and 3 reports. •Collaborated with industry professionals from more than 5 different companies such as Perkin Elmer, Metrohm, Mettler Toledo, BASF and Merck to gather product knowledge, obtain market awareness, organise focussed application training, coordinate routine maintenance of analytical instruments and deliver seminars. •Mentored undergraduate students in professional skills, material and energy balances, process flow sheets and advised researchers in experimental design and analytical techniques like Ion Chromatography, GC-MS and IR spectroscopy. Technical skills and details: • Fluidised bed reactor design, installation, commissioning and operation. • Thermo-catalytic process development for cellulose and lignocellulose conversion to chemicals like 5-Chloromethyl furfural, levoglucosenone and other substituted furans. • Biomass conversion to energy, fuels and chemicals. • Origin Lab, Minitab and MS Excel for data analysis • Powder handling • Analytical techniques:UV/Vis, LCMS GCMS, HPLC, IC, XRD, TGIR, FTIR and synchrotron infra-red (IR) microspectroscopy for obtaining insights on the chemistry of lignocellulose conversion and characterisation of platform chemicals that find applications in pharmaceutical, polymer, paint and food and dairy industry. I also spearhead laboratory operations and actively implement Occupational, Health and Safety (OH&S) policies. Some of the responsibilities include: • Performing risk assessments • Ensuring appropriate documentation (SOPs and SDS) • Managing chemical storage, transport, handling and disposal. • Representing the laboratory in department safety committee meetings • Participating in safety inspections

• Commissioning ambr15f (advanced microscale bioreactor fermentation) • Bioprocessing: Yeast and bacterial cell culture for producing platform chemicals • Investigation of heterogeneity in the microbial cell population under stress

CHE 2162: Material and Energy balances CHE 3162: Process Control ENG 1002: Engineering design: cleaner, safer, smarter

I was entrusted with following responsibilities while working as a Scientist: • Mammalian cell line and cell culture process development • Molecular cloning • Mammalian cell culture (Cryopreservation, revival and maintenance of mammalian cells) • Mammalian cell handling (CHO and HEK) in shake flasks, spinner flasks, T-flasks, AMBR, bioreactor and microwell plates • Stable and transient transfections in CHO and HEK. • Generation of sub-clones of cell lines expressing mAbs by LDCC • Screening and evaluation of clones expressing mAbs using AMBR (Advanced Microscale Bioreactor System) • Early stage cell culture process development for mAbs in tandem with clone and media screening using statistical software like JMP and MS Excel. • Generational stability study of a cell line to determine its suitability for operations at a scale of (200-15000) L. • Preparation of a research cell bank of 1000 vials using an automated banking system “Fill-IT” to demonstrate its efficacy and robustness for cGMP. • Assisting protein expression in E. coli and its subsequent purification. • Clarification of cell culture broth. • Composition of scientific and technical reports. • Composition of “Standard Development Procedures” and "Standard Operating Procedures (SOPs)" • Collaborating with other functions like QC, QA, Regulatory Affairs and Manufacturing to draft reports and accomplish projects. In addition to aforementioned responsibilities, I was actively involved in the concerted endeavours of making the workplace safer for employees.

As a technical trainee, I was involved in • Characterization of a microbial working cell bank - plaque assay and verification of the transgene sequence and integrity. • Testing of mammalian working cell banks for sterility, thaw viability and mycoplasma. • Isoenzyme analysis and PCR for verifying the identity of host cell line. • Molecular Cloning • Mammalian Working and Extended Cell bank preparation in cGMP facility • Composition of relevant scientific and technical reports.

Completed a rigorous professional course on Data Science and Big Data analytics. Certificate available at: https://mitxpro.mit.edu/certificates/cf3bf904c5fe4170adc52e0193c08ff0

Best Outgoing Student. Graduated with Honors. Received Dean's List Scholarship (Top 2% category) in all the four academic years. I was also conferred “B Umasekar Award” for securing highest marks in “Genetic Engineering”.