EDUCATION
North Carolina State University, Raleigh, NC
– MS Biomanufacturing (Upstream)
VIT University, Vellore, India
– B.Tech Biotechnology (Engineering)
EXPERIENCE
Manufacturing Lead, Biogen, RTP, NC
Manufacturing Associate III/Production Engineer, Biogen, RTP, NC
Manufacturing Associate II/Production Engineer, Biogen, RTP, NC
- Managing eight operators in the 2000L scale GMP cell culture manufacturing group with expertise in all upstream unit operations from vial thaw to harvest.
- Area SME in Oracle, NeoPLM (Recipe Driven Operations), Trackwise initiator, editing GMP documentation, and process equipment troubleshooting
- As Production Engineer, help troubleshoot upstream and downstream automation and process issues faster as the first line of defense on the floor, reducing call rates to outside departments to resolve common and recurring problems.
- Support Biogen Forward initiatives by implementing process efficiencies, leveraging connections within Validation and Process Engineering to push projects to completion.
- As Human Performance ambassador, have helped to increase use of Devonway and in-person Hu tools, helping beat department’s 2018 and 2019 Hu utilization goal.
- RTP Lead for IGNITE, an Employee Resource Network for early career professionals and their advocates.
Temp. Process Development Associate, KBI Biopharma, RTP, NC
- Created and executed statistically-designed experiments for two client-driven projects to develop mammalian cell culture processes in 2L Applikon bioreactors and shake flasks.
- Conducted literature review and partnered with client scientists to troubleshoot process issues.
Teaching Assistant, Biomanufacturing Training and Education Center – NCSU, Raleigh, NC
- Graduate Teaching Assistant for Downstream Processing Science; supported lab sessions and grading.
- Earned a Six Sigma Green Belt for developing and co-delivering a week-long statistics course titled “Design of Experiments (DOE) Training for Biomanufacturing Process Development.”
Summer Intern, Synthetic Genomics Inc., San Diego, CA
- Performed 17 fermentation runs in 2L New Brunswick fermenters to evaluate a DOE for optimizing process conditions for production of the desired product from a genetically modified marine heterotrophic alga.
- Elucidated effects of edge-of-design space environmental conditions on algal growth and product formation.
- Generated predictive models to find optimal conditions for six Key Performance Indicators of the product using SAS JMP Pro 11 statistical software.
Microbiology Intern, CBL Rietzler Analytik, Ansbach, Germany
- Undergraduate thesis: Helped improve the understanding of the spread of Legionnaire’s disease in south Germany by performing statistical analysis on contamination results from over 4000 Legionella samples.
- Used Excel and found correlations between source of water, water temperature, and bacterial growth as well as seasonal variability in contamination levels.
TECHNICAL SKILLS
Software
- GMP Manufacturing: Oracle, Trackwise, myCIMS, NeoPLM, KNEAT, SIMCA, DeltaV;
- Analytics: SAS JMP 11.2, Microsoft Excel 2013
- Bioinformatics: KEGG; BLAST; Archetype; ExPASy; NCBI Primer Design; WoLF PSORT
Cell Culture and Analytical Sciences
- Bioreactors: Experience with Sartorius BioStat A (5L), B (2L), D (30L,300L), New Brunswick BioFlo 310 (2L), Applikon 2L/5L glass bench scale fermenters, 100, 750, 2000L stainless steel bioreactors, GE WAVE bags
- Intermediate analysis: YSI and NOVA analyzers; BioRad cell counter; ViCell cell counter, HPLC for amino acid quantification
RELEVANT GRADUATE COURSES
- Global Regulatory Affairs for Medical Products: Coursework related to quality systems such as FDA’s 21 CFR regulations, facility and equipment validation, regulatory filing, and failure investigations.
- Biopharmaceutical Characterization: Intensive lab study of analytical method development and validation of techniques such as MS, SDS-PAGE, and HPLC per USP, FDA, and ICH guidelines.
- Case Studies on mAb and Influenza Vaccine Production: Two team-based technical reports to remodel the BTEC facility to produce biopharmaceuticals – including upstream processing, downstream processing, regulatory requirements, GMP utilization and QC/QA methodology.
- Six Sigma DMAIC: Project-based statistical engineering methods for LEAN manufacturing and business processes, statistical process control using JMP, and application of Six Sigma and 5S BOK such as CAPA
- Operations Research: Quantitative modeling with linear and dynamic programming; Algorithmic approaches to optimization using Markov processes, queuing, and sensitivity analysis.
RESEARCH PROJECTS
- Characterized the biochemical composition of the photosynthetic microalga Dunaliella under various nitrogen sources in Dr. Heike Winter-Sederoff’s NSF-funded group.
Construction of a low-cost microbial fuel cell to treat domestic wastewater using a consortium of genetically modified bacteria to degrade waste and generate electricity.
Detection and identification of faecal coliforms found in food samples in Vellore.
- for poster presentation at the National Conference on Food Tech, 2012 at Periyar University, India.
A Study of variation in blood IgE levels among smokers and non-smokers.
SUSTAINABILITY, OUTREACH, AND EXTRACURRICULARS
- Member of International Society for Pharmaceutical Engineering since 2013.
- Volunteered for the Advanced Biofuels Leadership Summit 2014 and 2015; attended the ARPA-E Energy Innovation Summit 2014.
- Authored a concept paper on self-sustainable energy-independent community housing for affordable rural development in India during Fall 2012.
- Set up and supervised a rural recycled waste handicraft initiative in Vellore as a model for social entrepreneurship in Fall 2012.
- Participated as a delegate in international level Model United Nations conferences at the collegiate level, including WorldMUN 2011 hosted by NUS, Singapore.
- Served in the core committee of the VIT Dramatics Club with experience in scriptwriting, directing, and acting from 2010-2012.
- Composed musical scores for three short films, two plays, and a YouTube show.
Sid Jain 