Dimitry Zelenyuk Email & Phone Number | I am an analytical team leader with strong and diversified technical and scientific knowledge in Analytical Chemistry, Manufacturing and Control (CMC) activities, Quality Assurance and Technical Documentation in advancing small and large molecules from early phases through clinical development and product launch. Proficient with recognized accomplishments in working with cross-functional CMC teams and drug product and analytical development, quality assurance and technical documentation supporting overall drug development process in GI, CNS, Women’s Health, and Ophthalmology therapeutic areas. Solid experience and in-depth knowledge in the following key-areas of expertise: - CMC: managed all analytical CMC activities and budgets, representative in project teams, successfully led technology transfers for numerous projects to commercial sites. - Drug Product development: led analytical teams in development through various stages of drug product development, vendor selection, DS and DP specifications to ensure product quality, and worked closely with formulators to make key drug product decisions during development and DOE studies for oral, parenteral, and ophthalmic formulations. - Analytical Method Development: developed and validated numerous analytical methods to analyze raw materials, drug substances (DS) and drug products (DP). Developed and executed transfer strategies to support product commercialization. - Quality Assurance: worked closely with quality assurance teams during setting of DS/DP specifications, issuance of analytical methods, review/disposition of clinical/pilot/registration batches, review/approval of deviations, out-of-trend, out-of-specification (OOS) investigations, implementation of CAPAs and participating in pre and post approval audit inspections (PAI). - Technical Writing: authored numerous analytical documents (methods, memos, justifications, product shelf-life, protocols, reports, stability trends) to support testing of raw materials, DS and DP. Authored CMC module 2 and 3 sections in over 30 individual product applications filed in US and worldwide. As analytical SME, responsible for providing responses to various regulatory agency requests during review/approval of the filed applications. - Leadership/Collaboration: led multiple cross-functional project teams, supervised scientists, mentored others in analytical method development/validation/formulation support and product development through collaborations.

Dimitry Zelenyuk

I am an analytical team leader with strong and diversified technical and scientific knowledge in Ana...
837 Kallin Avenue, Long Beach, United States

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Dimitry Zelenyuk’s Email dimitry.zelenyuk@apellis.com

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Dimitry Zelenyuk’s Location 837 Kallin Avenue, Long Beach, United States

Dimitry Zelenyuk’s Current Industry Avidity Biosciences

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Work Experience

Avidity Biosciences

Associate Director, Quality Control

2024-01-01 00:00:00 - Present

Apellis Pharmaceuticals

Associate Director, Quality Control

2022-09-01 00:00:00 - 2023-09-01 00:00:00

Heron Therapeutics

Associate Director, Quality Control

2021-01-01 00:00:00 - 2022-08-01 00:00:00

Abbvie

Sr. Manager (R&D Analytical Development)

2016-09-01 00:00:00 - 2020-10-01 00:00:00

Allergan

Principal Scientist

2016-04-01 00:00:00 - 2016-09-01 00:00:00

Actavis

Associate Director Analytical R&D

2014-01-01 00:00:00 - 2015-01-01 00:00:00

Bioscreen Testing Services

Chemist III

2001-01-01 00:00:00 - 2002-01-01 00:00:00

Grifols

Laboratory Technician / Chemist

2000-01-01 00:00:00 - 2001-01-01 00:00:00

Basf

Laboratory Technician

1998-01-01 00:00:00 - 1998-01-01 00:00:00

Skills

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Languages

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FAQ About Dimitry Zelenyuk

Dimitry Zelenyuk is located at
837 Kallin Avenue, Long Beach, United States

Dimitry Zelenyuk is a I am an analytical team leader with strong and diversified technical and scientific knowledge in Analytical Chemistry, Manufacturing and Control (CMC) activities, Quality Assurance and Technical Documentation in advancing small and large molecules from early phases through clinical development and product launch. Proficient with recognized accomplishments in working with cross-functional CMC teams and drug product and analytical development, quality assurance and technical documentation supporting overall drug development process in GI, CNS, Women’s Health, and Ophthalmology therapeutic areas. Solid experience and in-depth knowledge in the following key-areas of expertise: - CMC: managed all analytical CMC activities and budgets, representative in project teams, successfully led technology transfers for numerous projects to commercial sites. - Drug Product development: led analytical teams in development through various stages of drug product development, vendor selection, DS and DP specifications to ensure product quality, and worked closely with formulators to make key drug product decisions during development and DOE studies for oral, parenteral, and ophthalmic formulations. - Analytical Method Development: developed and validated numerous analytical methods to analyze raw materials, drug substances (DS) and drug products (DP). Developed and executed transfer strategies to support product commercialization. - Quality Assurance: worked closely with quality assurance teams during setting of DS/DP specifications, issuance of analytical methods, review/disposition of clinical/pilot/registration batches, review/approval of deviations, out-of-trend, out-of-specification (OOS) investigations, implementation of CAPAs and participating in pre and post approval audit inspections (PAI). - Technical Writing: authored numerous analytical documents (methods, memos, justifications, product shelf-life, protocols, reports, stability trends) to support testing of raw materials, DS and DP. Authored CMC module 2 and 3 sections in over 30 individual product applications filed in US and worldwide. As analytical SME, responsible for providing responses to various regulatory agency requests during review/approval of the filed applications. - Leadership/Collaboration: led multiple cross-functional project teams, supervised scientists, mentored others in analytical method development/validation/formulation support and product development through collaborations.

Dimitry Zelenyuk currently works in the Avidity Biosciences |

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Dimitry Zelenyuk has prior
experience in the following industries:
Apellis Pharmaceuticals | Heron Therapeutics | Abbvie | Allergan | Actavis | Bioscreen Testing Services | Grifols | Basf

Dimitry Zelenyuk has the following professional experience:
Avidity Biosciences | Apellis Pharmaceuticals | Heron Therapeutics | Abbvie | Allergan | Actavis | Bioscreen Testing Services | Grifols | Basf