David Didio

David Didio Email and Phone Number

Senior Principal Scientist with Experience in Protein and mRNA Purification Processes @ Tessera Therapeutics
David Didio's Location
Medford, Massachusetts, United States, United States
David Didio's Contact Details
About David Didio

Protein purification scientist with experience using current downstream and process analytical technologies in the development of purification processes for biological molecules expressed in mammalian and bacterial expression systems. In current role responsible for the process development for pre-clinical and clinical/FIH programs and process characterization for late-stage programs. Experience managing programs externally with CMOs and internal process development, technical transfer and process scale-up and modeling. Successfully completed multiple FIH programs. Knowledge and experience with process characterization and viral clearance studies. Responsible for authoring and review of sections for IND and BLA applications.High Throughput and Laboratory Automation: Responsible for the implementation of high throughput instrumentation and execution of downstream process development and process characterization studies. Experience with laboratory automation includes scripting and integration of analytical instrumentation for high throughput workflows. Additional experience with HPLC and other instrumentation to support high throughput workflows to streamline process development timelines.Evaluation of new technologies and platforms. Various positions on CMC teams and working in cross functional teams with analytical, upstream and drug product development to support program development activities and meet program timelines.

David Didio's Current Company Details
Tessera Therapeutics

Tessera Therapeutics

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Senior Principal Scientist with Experience in Protein and mRNA Purification Processes
David Didio Work Experience Details
  • Tessera Therapeutics
    Senior Principal Scientist
    Tessera Therapeutics Apr 2022 - Present
    Somerville, Ma, Us
  • Bristol Myers Squibb
    Senior Principal Scientist
    Bristol Myers Squibb Apr 2021 - Apr 2022
    Lawrence Township, Nj, Us
  • Celgene
    Principal Scientist
    Celgene Oct 2019 - Mar 2021
    Summit, New Jersey, Us
  • Celgene
    Senior Scientist
    Celgene Apr 2017 - Oct 2019
    Summit, New Jersey, Us
  • Shire
    Senior Downstream Development Engineer
    Shire Dec 2015 - Mar 2017
  • Ambrx
    Scientist, Process Development, Cmc
    Ambrx Sep 2013 - Aug 2015
    San Diego, Ca, Us
  • Allergan
    Scientist
    Allergan Feb 2012 - Sep 2013
    Dublin, Coolock, Ie
    • Protein Purification Scientist in Biologics Process Science Group Working Independently and in Cross-Functional Teams to Develop Downstream Purification Processes for Early and Intermediate-Stage Biological Molecules Expressed In Bacterial Expression Systems• Downstream Project Lead for Scale-Up and Technical Transfer of Investigational Therapeutic for Phase I GMP Manufacture – Representation on CMC Team; Setting TPP(s), CQA(s), and CPP(s). Additional Responsibilities for Project Budget, Scheduling, and Coordinating across Functional Areas to Meet Project Timelines
  • Allergan
    Sr. Professional
    Allergan Aug 2008 - Feb 2012
    Dublin, Coolock, Ie
    • Project Lead in the Development of Custom Affinity Ligand(s) for Candidate Therapeutic Molecules with Third-Party Vendor(s)• Design and Execution of Development and Process Characterization Studies for Regulatory Submissions• Expertise in Chromatographic Separations, Including: Hydrophobic Interaction, Ion-Exchange, Size-Exclusion, Reverse-Phase, Mixed-Mode and Affinity Chromatography• Expertise in High-Throughput Screening Techniques and Laboratory Automation – Using TECAN Freedom Evo 100 and 200 Systems and EvoWare Software• Expertise with Standard Preparative and Analytical Technologies: AKTA Explorer, Pilot, and AKTA Ready and Unicorn Software; HPLC with Agilent and Waters Platforms and Empower Software; Caliper LabChip and MF-UF Applications• Experience in Standard Molecular Biology Techniques, Including: DNA/RNA Preparation, IEF, SDS-PAGE, 2D-DIGE• Knowledge of FDA and ICH Guidelines and Implementation of Quality by Design Principles in the Development of Downstream Purification Processes and the Technical Transfer of Laboratory-Scale Purification Processes for Phase I and Phase II GMP Manufacture• Knowledge of Design of Experiments Principles for Process Development Methodologies and the use of JMP for Statistical Analyses of Process Development Results• Working in Multi-Disciplinary Groups to Coordinate Development Projects Within Assigned Timelines• Trained New Employees in Various Aspects of Downstream Purification including Good Laboratory Practices, Analytical Method Development, and Preparative Chromatography Theory and Techniques
  • Bristol-Myers Squibb, Princeton, New Jersey
    Associate Scientist
    Bristol-Myers Squibb, Princeton, New Jersey Apr 2004 - May 2008
    Lawrence Township, Nj, Us
    • Research Scientist in Bioprocessing and Protein Purification Development Group• Developed Novel On-Column Disaggregation Processing Step for the Recovery of Functional Monomeric Material from High Molecular Weight Species in Affinity Chromatography• Expertise in Protein Refolding and Early to Late-Stage Biological Purification Development of Recombinant Fc-Proteins and Monoclonal Antibodies.• Expertise in Technical Transfer of Laboratory-Scale Purification Processes to Pilot and Manufacturing-Scale and cGMP Regulations • Designed and Performed Development and Process Validation Studies for Regulatory Submissions• Composing Technical Documents for Biological Licensing Application • Working in Multi-Disciplinary Groups to Coordinate Development Projects Within Assigned Timelines• Experience in Project Management and Manager of People

David Didio Skills

Technology Transfer Purification Biopharmaceuticals High Throughput Screening Hplc Design Of Experiments Quality By Design Gmp Laboratory Automation Akta Downstream Processing Cgmp Manufacturing Empower Jmp Cmc Unicorn Software

David Didio Education Details

  • Upstate Medical University
    Upstate Medical University
    Pharmacology

Frequently Asked Questions about David Didio

What company does David Didio work for?

David Didio works for Tessera Therapeutics

What is David Didio's role at the current company?

David Didio's current role is Senior Principal Scientist with Experience in Protein and mRNA Purification Processes.

What is David Didio's email address?

David Didio's email address is dd****@****ene.com

What schools did David Didio attend?

David Didio attended Upstate Medical University.

What skills is David Didio known for?

David Didio has skills like Technology Transfer, Purification, Biopharmaceuticals, High Throughput Screening, Hplc, Design Of Experiments, Quality By Design, Gmp, Laboratory Automation, Akta, Downstream Processing, Cgmp Manufacturing.

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