Antonia Nikitenko

About Antonia Nikitenko

Regulatory Specialist with extensive and diverse background in organic synthesis and medicinal chemistry. Currently enrolled in Master\'s Degree program, Quality Assurance/Regulatory Affairs, Temple University. Highly skilled in rapid scale-up and early process research at the discovery-development interface. Hands-on experience in resolving solid state issues including crystallization, classical resolution, salt and polymorph screen. Characterized as a strong leader in managing research teams and developing long-term collaborations with U.S, European, and Asian CROs. Partnered with both internal and contract attorneys in drafting patent claims and responses to Office Actions. Recognized with multiple patents, publications, and presentations. Bi-lingual fluency in English and Russian; working knowledge of German.Specialties: Product stewardship and regulatory support of internal and external customers.Rapid scale-up of complex organic molecules (potential lead compounds) and early process research; polymer synthesis and formulation; organosilicone hybrid resins.Solid state issues: crystallization, salt formation.Chiral synthesis and chiral resolution.

Experience

1. Regulatory Specialist

   Momentive

   Jun 2014 — Present · Tarrytown, NY, US

   Providing Momentive customers with product safety/regulatory information in accordance with customer specific requirements and various international regulations. Documentation includes, but is not limited to: product origin statements, allergen statements, GMO certification, BSE/TSE, substances of concern statements, customer questionnaires, nutritional statements, animal testing statements, Halal statements. Use of SAP; coordination with various groups in the US as well as the Regulatory Affairs groups in other Momentive locations throughout the world.Halal certification of Momentive products and facilities Registration of new cosmetic ingredients with Personal Care Product Council – preparation and submission of applications for INCI names of Momentive products

Education

• Lomonosov Moscow State Academy of Fine Chemical Technology (MITHT)

  Diploma (with Honors; M.S, Chemical Engineering; Chemistry

  1980 — 1989

• Temple University

  Master’s Degree, Regulatory Affairs/Quality Assurance

  2012 — 2016

• Lomonosov Moscow State Academy of Fine Chemical Technology (MITHT)

  Ph.D., Organic Chemistry

  1980 — 1989

Skills

• Chromatography
• Research and Development (R&D)
• Drug Design
• Nmr
• Mass Spectrometry
• Medicinal Chemistry
• Nuclear Magnetic Resonance (Nmr)
• Nmr Spectroscopy
• Lc-Ms
• Characterization
• Synthetic Chemistry
• Chemistry
• Hplc
• Polymers
• Research
• Purification
• Patents
• Pharmaceutical Industry
• Process Chemistry
• Technology Transfer
• High-Performance Liquid Chromatography (Hplc)
• Liquid Chromatography-Mass Spectrometry (Lc-Ms)
• R&D
• Uv/Vis
• Drug Discovery
• Organic Synthesis
• Laboratory
• Analytical Chemistry
• Pharmaceuticals
• Synthetic Organic Chemistry
• Crystallization
• Gc/Ms
• Organic Chemistry