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Associate Principal Engineer

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• Over 10 years of experience in Pharmaceutical/Biopharmaceutical drug Manufacturing industry as a Process Engineer, Validation/Principal scientist and Quality Assurance with sound knowledge of Biopharmaceutical process design, Technology transfer, scale up, Drug product manufacturing and operation related activities in Pharmaceutical and Biopharmaceutical drug products.
• Depth knowledge and understanding of FDA 21CFR Part 210/211, 820, 11, ICH Guidelines and validations, Quality Assurance, Change control, CAPA, Trackwise, risk assessment, Deviations, and investigation, Root cause analysis.
• Experience working in cGMP environment, Good Manufacturing Practices (GMP) with Various dosage form formulations, Good Documentation Practices (GDP), Good Laboratory Practices (GLP).
• Detailed understanding and experience working of Drug substances, Excipients, API, drug product formulation of pharmaceutical and Biopharmaceutical drug products manufacturing in GMP environment.
• Familiarity with Quality System Management (QMS chapters) in terms of Validation and compliance, Tech transfer, Facilities, and engineering.
• Have depth knowledge of using applications like Track wise, SAP, Kneat eVal.
• Depth understanding and working experience with oral solid dosage form, parenteral/injectable dosage form, suspension operation and manufacturing, process, and product improvements.
• Knowledge about Regulatory requirements and filling.
• Knowledge and working experiences about managing Equipment life cycle from procurement to decommissioning.
• Experience in leading/working on Multiple projects for Biologics drug products and process characterization study for process improvements.
• Understanding and firsthand experience working on Data Integrity remediation project for laboratory analytical instrument to meet part 21CFR 11.
• Has gained expertise in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11, Data integrity requirements.
• Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, Validation Master plan, validation summary report, SOPs, Protocol Deviation, Risk Assessment, Decommission protocols, Periodic Review Report.
• Firsthand Experience in drafting, Executing, and reviewing all SDLC qualification documents (QAP, RSCS, AT, RTM, QASR, SDI) protocols, and SOPs to ensure it meet GxP and FDA regulations.

Organized Principal Scientist skilled in designing and executing 5 preclinical and 1 clinical phase research projects per year. Superb written and verbal communication skills. Seasoned at preparing reports, publications and oral presentations for small or large groups. Successfully secured and worked on completing milestones for 3 separate collaborations with industry partners. Oversaw the transition from preclinical to clinical drug use in a Phase 0 and Phase I/II. Synthesized all drug formulations that went into preclinical and Phase 0 clinical work. Successfully optimized and transferred technology for the drug production to the selected CDMO for the primary drug product. Designed and developed drug formulations for the other pipeline projects as well as carried out the synthesis and characterization of all drug material. Well versed now in Chemistry, Manufacturing and Controls (CMC), Quality and Manufacturing on top of laboratory research and development, intellectual design and project/team management.

Determined and well-rounded individual with more than 20 years working as Scientist within the broader microbiome industry. Sharp and focused professional offering skills in nucleic acid extraction, biochemistry, NGS workflows and applying academic discovery to commercial product and IP generation.

Accomplished Principal Scientist with a distinguished career at Merck & Company and Schering-Plough, co-inventing 3 FDA-approved drugs and leading to 5 marketed products. Demonstrates strong leadership and technical writing expertise, with a proven track record in drug discovery and development. Specializes in lab safety protocols and risk assessment, driving innovation and excellence in pharmaceutical research.

Determined and well-rounded individual with more than 17 years working as Scientist within industry. Pursuing role and leveraging exceptional technical knowledge to better satisfy customer needs.

Jim Leisten

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Principal Scientist

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Bachelor of Science - Science

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Principal Scientist

Bachelor of Science - Science

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