Elena Gontarz

Lead, trained, motivated the team of the Global SMEs to support new and existing business through commercial team engagements and technology road mapping planning and execution.

· Participated in creation and implementation of the new commercial processes (Quote to Win) for strategic alignment across all of the business division for new business opportunities.

· Lead, advised, and trained Global SME team to design effective science-based strategy development for >300 contract CMC programs in development and in commercialization stages for various protein-based drug candidates.

· Acted as a key technical and commercial stakeholder within development teams and across all of the Drug Substance/Drug Product organization to optimize platform process offering for Bispecific and Fc-Fusion offerings resulting in over 25% timeline reduction.

o Commercialized additional offerings in industry-leading Quick to Clinic brand.

· Key stakeholder for new technology development and establishment within the drug substance division.

o Evolved technology road mapping framework through industry best practices.

o Participated in the creation of the next Gen manufacturing design and implementation of the New Cell line expression technology.

o Leader (L2) in the BioPhorum Development Group, with emphasis on First in Human approach.

Pioneered and established a new SME role to support new and existing business as well as technology development framework across drug substance division.

· Lead effective science-based strategy development for >500 contract CMC programs in early development, late development, and in commercialization stage for various protein-based drug candidates.

o Provided technical sales support in partnership with commercial team to help customers understand our capability and capacity through customer visits, partnering meetings and presentations at key conferences, seminars, and roadshows.

o Formulating CMC strategy and execution based on client needs.

· Acted as a champion and integrator within development teams and across all of the Drug Substance/Drug Product organization to optimize platform process offering for IgG1/4, resulting in over 20% timeline reduction.

o Commercialized industry-leading Quick to Clinic.

· Lead and participated in establishment of the new technology within the division.

o Supported the creation of technology road mapping framework through industry best practices.

o Drove implementation of the following technologies: MAM (Multi Attribute Method), Ambr® 250, ExpiCHO-S system, etc.

o Participation in BioPhorum (BPOG): L2 for Development Group & L3 for ILM/RTR.

· Designed new Customer Centric Program for Patheon Biologics BPS division for additional Scientific and Technical Support during Client’s program execution.

· Planning and execution of the ELISA development for monoclonal antibodies and Enzyme Activity Assay for Phase I/II/III programs.

· Establishment and subsequent trainer on impurity, potency, and identity ELISAs and Enzyme Activity Assays.

· Authorship of multiple ELISA qualification and validation protocols for Phase I/II/III and Pre-PPQ programs.

· Method transfer from Analytical & Formulation Sciences to Quality Control and across multiple company sites.

· Participation in harmonization activities to simplify ELISA method transfer across multiple company sites.

· Comparability, Forced Degradation, and Reference Material Qualification Study Development and Support.

· Knowledge of ICH and FDA guidelines.

Analytical Project Lead:

Work with Clients as analytical project lead/core team representative in order to manage all of the Analytical activities (development, establishment, qualification, validation, etc.) for all of the analytical methods for release of GMP manufactured Drug Substances for Phase I/II/III and Pre-PPQ Programs, as well as any additional characterization studies that come with Phase III àCommercialization phases.

• Protein production and purification in E.Coli, chlamydomonas reinhardtii, pichia pastoris, and bacillus thuringiensis

· Developed purification protocol and assays to study the inhibitory effect of organophosphates on HSL and AChE. Applied new and existing assays to determine IC50s and kinetic parameters of organophosphates on HSL and IC50 values for AChE

· Standardized and applied protocols to study the binding properties of large antiviral polyamides to determine binding sites and affinities on biologically relevant DNA (HPV16)