Eugene Livshits
Vice President Chief Technical Affairs Officer @Admix Pharma Laboratories, Llc
Signup · Get unlimited contacts
WORK HISTORY
Vice President Chief Technical Affairs Officer @Admix Pharma Laboratories, Llc
South Plainfield, NJ, US
Innovative, results-oriented manager and scientist with more than 25 years of diverse experience in regulatory practice (including Global Regulatory), quality assurance, analytical chemistry, manufacturing of solid dosage, liquid products, injectable, biologics and medical devices. An outstanding problem solver. Excellent business sense with practical technical skills. Ability to communicate with people of various personalities and at any level of technical and business expertise. Excellent mentoring skills. Lead the Technical Operation of the Pharmaceutical Companies on contractual and permanent bases.Experience as a board member and leading officer in different pharmaceutical companies.Areas of expertise include: Regulatory practice including ANDA, NDA, 505(b)2, IND, BLA, IMPD, CTA, PMA, OPDP and Chemistry, Manufacturing, and Controls (CMC), also including Global Regulatory Quality Assurance cGMP, cGLP, cGCP and ISO Analytical methods and instrumentation Product development Compliance All phases of manufacturing of solid and liquid dosage products, injectable (including auto injection), biologics and medical devices
EDUCATION
University of Chemical Technology of Russia, Moscow, USSR
Doctor of Philosophy (Ph.D.), Chemistry
International Patent courses, Moscow USSR
Patent expertise certification, Patents
SKILLS
ABOUT EUGENE LIVSHITS
Pharmaceutical Professional with extensive Technical Operations, Quality, and Regulatory Experience.Held positions leading Technical Operations of Generic Pharmaceutical Companies on contractual (though personally owned EHL Pharma, LLC) and permanent basis.Areas of expertise include- Compliance (including preparation, conduct of, and participation in regulatory agency and client audits as well as mock and actual recalls- All phases of manufacturing of solid and liquid dosage products- Analytical methods and instrumentation - Product development including NDA and ANDA preparation and filing- GMP, GLP, and ISO Quality Assurance and RegulatoryWith over 20 years in pharmaceutical and biotech leadership, I’ve built my career on driving technical operations, quality assurance, and regulatory compliance that meet the highest industry standards. As Vice President and Chief Technical Affairs Officer at Admix Pharma Laboratories, I specialize in aligning technical processes with stringent regulatory demands, from GMP-compliant manufacturing to successful product filings (ANDA, NDA, BLA).My passion lies in ensuring teams are not only compliant but also empowered to operate efficiently and effectively in high-stakes environments. I understand the unique pressures that leaders in regulated industries face from maintaining quality control to handling rigorous audits and the critical need for leadership development that translates directly to on-the-ground results.That’s why I’ve partnered with Hallmark Leadership, a leading provider of action-based leadership solutions designed for technical and regulated sectors. Our approach ensures that leaders aren’t just knowledgeable but fully equipped to apply strategic, measurable actions in their teams. By focusing on accountability and real-world application, Hallmark’s programs create sustainable, results-driven leadership that impacts quality, compliance, and operational efficiency.If you’re looking to enhance your team’s leadership capabilities with a proven, results-oriented approach, I’d love to connect. Let’s discuss how action-based leadership can drive meaningful change in your organization.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.