Damián Derincovsky
Technical Operations Leader
Summary
Senior Technical Operations Leader with 18+ years of biopharmaceutical industry experience, specializing in large molecule process development and commercial manufacturing. My expertise spans team and project management, R&D, scaling up from pilot to production, international technology transfer, and regulatory compliance (US, EU, RoW).
I have a strong track record in providing scientific support for drug substance commercial manufacturing, ensuring seamless operations and timely supply to the market. Additionally, I have successfully contributed to business development efforts, establishing strategic partnerships and closing deals in the contract manufacturing sector.
My academic background includes a Master's in Bioengineering, an M.Sc in Pharmaceutical Biotechnology, and an MBA, providing robust technical and business expertise that fuels my exceptional leadership, negotiation, and decision-making capabilities. I thrive in collaborative team environments and consistently excel under pressure, delivering outstanding results.
Overview
18
18
years of professional experience
Work History
Deputy Head, Manufacturing Sciences and Technologies (MS&T)
Novartis Pharma
10.2015 - 12.2021
- Acted as Deputy of MS&T Head & SPOC for intra- and inter-site units in a major Novartis Biologics Manufacturing Site, focused on Monoclonal Antibody drug substance production.
- Led 40+ associates, providing performance feedback and facilitating salary increases/bonus discussions.
- Managed MS&T yearly budget (~9 MM€), developed business cases for unit investments (CAPEX/OPEX), and ensured on-time tracking and planning.
- Headed the MS&T Technology Transfer and Project Team (6 direct reports), overseeing LCM projects and intra/inter-site Technology Transfer implementation.
- Directed critical projects as Project Leader, establishing project governance, coordinating efforts, and serving as the Single Point of Contact (SPOC) for global and local stakeholders.
- Supervised five mammalian process technology transfers, involving regulatory strategy definition and post-approval follow-up.
- Functioned as de facto lead for operational activities in MS&T, ensuring overall performance, quality, costs, supply, and resource management to achieve unit goals and KPIs.
- Member of MS&T Leadership Team, Site Middle-Management Leadership Team, Site Deviation Coordinators team and Site Deviation Review Board.
- Led the 'Future Workstream' initiative, implementing cutting-edge technologies (e.g., PAT [RAMAN], digital analytical tools [MVDA, SIMCA OnLine]) to meet increased demand for Novartis blockbusters, resulting in ~12% gains in final batch yields (20+ mUSD per year).
- Acted as MS&T Process Validation Lead (8 direct reports), supporting process validation activities, defining strategies, and leading the Process Validation team.
- Served as MS&T Analytics Lead (10 direct reports), overseeing analytics team management and planning aligned with the site's needs.
- Collaborated with global stakeholders, including Supply and Brand Leads and Senior Management, to align on project prioritization, lead improvement, cost reduction, and LCM activities for business continuity and supply risk mitigation.
- Served as MS&T SPOC and coordinator for 15+ Health Authorities inspections (e.g., FDA, EMA, ANSM).
- Maintained close contact with Regulatory Affairs for dossier submission preparation for four commercial products.
Head (a.i.), Manufacturing Sciences and Technologies (MS&T)
Novartis Pharma
01.2016 - 06.2016
- Directed the MS&T department and cross-functional teams, leading over 40 associates divided into four teams (USP, DSP, Process Validation, and Analytics).
- Oversaw Life Cycle Management, troubleshooting, and optimization efforts for four commercial blockbuster products, ensuring on-time and complete market supply (~130 Drug Substance batches / 300mUSD COGS per year).
- Partnering with Supply Chain, Production, Quality Control & Assurance and Regulatory Affairs to improve Site performance, focusing on productivity, efficiency and compliance.
- Engaged as an active member of the Site Leadership Team, contributing to strategic decision-making, fostering cross-functional collaboration, and driving performance improvements across departments.
- Collaborated with global functions to seamlessly align and execute business strategies.
Head, Contract Manufacturing
Combino Pharm S.L
05.2014 - 10.2015
- Led the Contract Manufacturing department, supervising activities and budgets, reporting directly to the CEO, and frequently interacting with senior stakeholders in the company's executive Lead Team.
- Produced feasibility studies and quotes for new projects.
- Generated commercial contracts and Technical Agreements.
- Supported designing and managing a High Potent API (HPAPI) unit for small molecules, built for Contract Manufacturing activities.
- Coordinated directly between customers and the Malta-based production plant to facilitate technology transfer and project implementation while adhering to cGMP guidelines for new projects.
- Defined project milestones and guaranteed timely completion, from pilot validation batch production to commercial product launch.
- Executed technical transfer and successful day-zero commercial launch of 10 products.
- Established direct contact with various departments, including Finance, Manufacturing, QC, QA, Marketing, IP, and Legal, to evaluate and secure approval for new projects.
- Search for and pursue new projects and customers, and ensure consistent follow-up.
- Represented the company in multiple international pharmaceutical industry fairs, including CPhI.
Technical Advisor
Algenex, S.L.
01.2012 - 06.2012
- Designed the Drug Substance (Downstream, DSP), Drug Product (Aseptic filling) and Quality Control (InProcess Control, IPC) areas in the production plant in adherence to cGMP regulations.
- Designed the R&D (Downstream) and QC laboratory areas in compliance with Good Laboratory Practice (GLP) standards.
- Outlined equipment and material requirements for both Production and QC, including associated costs.
Head, Downstream Process Development
Quimbiotec, C.A.
01.2004 - 03.2011
- Commissioned and managed the Biotechnology Downstream Laboratory under GLP regulations.
- Included area design, equipment, materials, reagent procurement, staff supervision, and activity planning.
- Managed and supervised the aseptic filling area for Drug Product, managing technologies for liquid and lyophilized vials, and liquid pre-filled syringes while adhering to GMP guidelines.
- Direct lead of 6 associates, including feedback for performance reviews and salary increase/bonus discussions.
- Managed manufacturing of 132 small-scale and 43 large-scale (Drug Substance & Drug Product) batches for registration and marketing and handled all cGMP documentation related to processes.
- Successfully led the development of freeze-drying processes for 3 biological drug products, including formulation development and optimization.
- Developed, optimized, and scaled drug substance/drug product production processes for 6 biosimilars and 2 monoclonal antibodies (MAbs).
- Achieved a 25% reduction in COGS for Filgrastim (rHU-GCSF) by optimizing the production process and applying LEAN principles.
- Led development of analytical techniques, including RP-HPLC, SEC-HPLC, bioassay, ELISA, WB, and SDS-PAGE.
- Acting as a Technical Transfer Lead, facilitated the technical transfer and regulatory submission of various recombinant manufacturing processes for both mammalian and bacterial systems, including Recombinant Human Erythropoietin in Lakeville, Argentina; Recombinant Human Insulin in Denver, Argentina; Recombinant Factor VIII in PanGen Biotech, South Korea; and Filgrastim in Italy.
Skills
- MS Project (Proficient)
- Microsoft Office (Highly Proficient)
- UNICORN (Proficient)
- AGILE (Proficient)
- AQWA Trackwise (Proficient)
Additional Information
Master in Business Administration - MBA - (expected) 2024
Warwick Business School (United Kingdom)
Master in Bioengineering - 2014
Institut Químic de Sarrià, IQS (Spain)
M. Sc. Pharmaceutical Biotechnology - 2012
Institut Universitari de Ciència i Tecnologia, IUCT (Spain)
B. Sc. Biology - Major in Cell Biology - 2002
Simón Bolivar University (Venezuela)
Languages
Spanish
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
French
Upper intermediate (B2)
Timeline
Head (a.i.), Manufacturing Sciences and Technologies (MS&T)
Novartis Pharma
01.2016 - 06.2016
Deputy Head, Manufacturing Sciences and Technologies (MS&T)
Novartis Pharma
10.2015 - 12.2021
Head, Contract Manufacturing
Combino Pharm S.L
05.2014 - 10.2015
Technical Advisor
Algenex, S.L.
01.2012 - 06.2012
Head, Downstream Process Development
Quimbiotec, C.A.
01.2004 - 03.2011
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