Gurmukh Chanana
Solon,United States
Summary
Professional scientist with comprehensive experience and strong analytical skills. Proven track record in leading research initiatives, driving innovative solutions, and ensuring project success. Expertise in experimental design, data analysis, and scientific writing. Known for fostering collaboration, adapting to evolving requirements, and delivering impactful results.
Overview
38
38
years of professional experience
Work History
Sr. Principal Scientist
Hikma Pharmaceuticals
01.2016 - Current
- Develop and Manage new pipeline generic parenteral projects from inception to completion
- Plan and design formulation approaches for generic injectable products
- Plan and design robust lyophilization process using QbD principles
- Implement quality by design approach to formulation development and scale-up of generic injectable products
- Develop manufacturing process and scale-up design of experiments utilizing risk analysis and failure mode analysis of the drug product and processes and establish critical process parameters and critical quality attributes
- Support CMC documentation and filing of ANDA and market product applications
- Prepare responses for deficiencies in ANDA filings in timely fashion
- Prepare and support patent applications for formulations and manufacturing process
- Mentor and Manage direct reports (scientists and research scientists) in formulation research and development
Principal Scientist
West-Ward Pharmaceuticals
08.2015 - 12.2015
- Develop and Manage new pipeline generic parenteral projects from inception to completion
- Plan and design formulation approaches for generic injectable products
- Plan and design robust lyophilization process using QbD principles
- Implement quality by design approach to formulation development and scale-up of generic injectable products
- Develop manufacturing process and scale-up design of experiments utilizing risk analysis and failure mode analysis of the drug product and processes and establish critical process parameters and critical quality attributes
- Support CMC documentation and filing of ANDA and market product applications
- Prepare responses for deficiencies in ANDA filings in timely fashion
- Prepare and support patent applications for formulations and manufacturing process
- Mentor and Manage direct reports (scientists and research scientists) in formulation research and development
Sr. Formulation Scientist II
07.2014 - 07.2015
- Manage generic parenteral projects from inception to completion including technology transfer to manufacturing site
- The drug products range from liquids to lyophilized products
- Technology transfer lead for 3rd party manufacture of injectable drugs
- Plan and lead remediation of approved drug products, plan and execute CAPAs
- Plan and design formulation approaches for generic injectable products
- Plan and design robust lyophilization process using QbD principles
- Implement quality by design approach to formulation development and scale-up of generic injectable products
- Develop manufacturing process and scale-up design of experiments utilizing risk analysis and failure mode analysis of the drug product and processes and establish critical process parameters and critical quality attributes
- Write development reports and support CMC documentation and filing of ANDA and market product applications
- Prepare responses for deficiencies in ANDA filings in timely fashion
- Conduct QbD experiments and provide rationale and justifications for product and process specifications and in support of these justifications
- Prepare and support patent applications for formulations and manufacturing process
- Train & supervise scientists and research scientists in formulation research and development
Sr. Formulation Scientist-II
Boehringer Ingelheim
03.2012 - 07.2014
- Manage generic parenteral projects from inception to completion including technology transfer to manufacturing site
- The drug products range from liquids to lyophilized products
- Technology transfer lead for 3rd party manufacture of injectable drugs
- Plan and lead remediation of approved drug products, plan and execute CAPAs
- Plan and design formulation approaches for generic injectable products
- Plan and design robust lyophilization process using QbD principles
- Implement quality by design approach to formulation development and scale-up of generic injectable products
- Develop manufacturing process and scale-up design of experiments utilizing risk analysis and failure mode analysis of the drug product and processes and establish critical process parameters and critical quality attributes
- Write development reports and support CMC documentation and filing of ANDA and market product applications
- Prepare responses for deficiencies in ANDA filings in timely fashion
- Conduct QbD experiments and provide rationale and justifications for product and process specifications and in support of these justifications
- Prepare and support patent applications for formulations and manufacturing process
- Train & supervise scientists and research scientists in formulation research and development
Pr. Research Scientist II, New Products and Process Development
Pfizer, Inc
01.2009 - 04.2010
Pr. Research Scientist I, Formulation Development
Wyeth Research
01.2003 - 01.2008
Sr. Research Scientist II, Formulation Development
01.1998 - 01.2003
Research Scientist, Pharmaceutical R&D, Process and Technology Transfer
01.1996 - 01.1998
Project Manager and Senior Scientist
American Drug Development, Inc
01.1993 - 01.1995
Graduate Teaching Assistant
University of Tennessee, College of Pharmacy
01.1987 - 01.1993
Skills
- Innovative thinking
- Scientific writing
- Cross-functional teamwork
- Experimental design
- Intellectual property
- Expertise in research
- Results analysis
- Project management
- Research and experiments
- Research and publication
- Teamwork
- Teamwork and collaboration
- Problem-solving
- Multitasking
- Excellent communication
- Critical thinking
- Organizational skills
- Team collaboration
Timeline
Sr. Principal Scientist
Hikma Pharmaceuticals
01.2016 - Current
Principal Scientist
West-Ward Pharmaceuticals
08.2015 - 12.2015
Sr. Formulation Scientist II
07.2014 - 07.2015
Sr. Formulation Scientist-II
Boehringer Ingelheim
03.2012 - 07.2014
Pr. Research Scientist II, New Products and Process Development
Pfizer, Inc
01.2009 - 04.2010
Pr. Research Scientist I, Formulation Development
Wyeth Research
01.2003 - 01.2008
Sr. Research Scientist II, Formulation Development
01.1998 - 01.2003
Research Scientist, Pharmaceutical R&D, Process and Technology Transfer
01.1996 - 01.1998
Project Manager and Senior Scientist
American Drug Development, Inc
01.1993 - 01.1995
Graduate Teaching Assistant
University of Tennessee, College of Pharmacy
01.1987 - 01.1993
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