Onkar Manjrekar
Group Lead, Technical Operation and Process Safety Lab I @ AbbVie | PhD, CMC Development
- Role
- Group Lead, Technical Operation and Process Safety Lab at AbbVie
- Location
- North Chicago, IL, US
- LinkedIn followers
- 500 followers
About Onkar Manjrekar
I am a Principal Research Scientist at AbbVie with over 8 years of experience in the pharmaceutical industry. My core competencies are drug substance process development, scale-up, tech transfer, and process safety. I have successfully managed multiple projects from early-stage FIH trials to commercial qualifications, covering small molecule, drug linker synthesis, and ADC processes.
Experience
Group Lead, Technical Operation and Process Safety Lab
Apr 2024 — Present · North Chicago, IL, US
Serving as a liaison between the Process Research and Development scientific functions and the API Pilot Plant organization.• Assisting in the optimization and scale-up of synthetic processes and facilitating the implementation of the processes and new technologies in to the API Pilot Plant.• Providing technical oversight during production campaigns and supporting technical transfer to the ultimate commercial manufacturing site.• Managing processes entering the API Pilot Plant, including scheduling, equipment selection, materials tracking, authoring direction sets, obtaining safety analyses, and executing pre-runs.• Technical oversight of processes running the API Pilot Plant, and responsibility for process-troubleshooting in collaboration with the project teams.• Serving as primary point of contact between API Pilot Plant, project teams, Quality Assurance, and Environmental Health and Safety.• Reviewing and documenting data for cGMP execution of chemical processes.• Authoring campaign summary reports.• Identifying, evaluating, and implementing new technologies for the pilot plant and/or identifying opportunities to modify or leverage existing assets to enhance operational efficiency. Examples include automation, flow chemistry, novel separation, Process Analytical Technology (PAT) feedback control, and drying technologies.• Supporting the implementation of PAT.• Assisting with equipment specification, setup, data collection and analysis.• Interfacing with project teams to ensure that processes are safe and operable.• Partnering with API development teams to optimize processes for scale-up.• Identifying appropriate equipment and configurations; and Assisting with technology transfer of late stage processes to commercial sites, including process fit, identification of equipment needs, and facility modifications.
Education
Institute Of Chemical Technology
Bachelor of Technology - BTech, Dyes and Intermediates
Washington University in St. Louis
Master’s Degree, Energy Environmental and Chemical Engineering
2011 — 2014
Washington University in St. Louis
PhD, Energy Environmental and Chemical Engineering
2011 — 2015
Institute of Chemical Technology
Bachelor Of Technology, Dyestuff and Intermediates
2006 — 2010
Skills
- Chemical Engineering
- Distillation
- Numerical Analysis
- Catalysis
- High-Performance Liquid Chromatography (Hplc)
- Reaction Engineering
- Laboratory
- Statistics
- Modeling
- Laboratory Skills
- Process Simulation
- Quality by Design
- Dynochem
- Process Engineering
- C++
- Research and Development (R&D)
- Aspen Hysys
- Process Analytical Technology
- Research
- Organic Chemistry
- Materials Science
- Manufacturing Scale-Up
- Microsoft Office
- Simulations
- Fluid Dynamics
- Data Analysis
- Chemistry
- R&D
- Engineering
- Transport Phenomena
- Maple
- Spectroscopy
- Matlab
- Mass Transfer
- Hplc
- Heat Transfer
- Aspen Plus
- Mathematical Modeling
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