Michael Adamo Email & Phone Number

Flemington, NJ, US

New Brunswick, NJ

*Managing a group of analysts performing biologics separation assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.*Responsible for delegating and monitoring.

Hopewell, New Jersey, United States

- As part of a team, responsible for implementing a platform size exclusion chromatography method and phase appropriate validation template for monoclonal antibodies.- Analytical subject matter expert for size exclusion chromatography.- Responsible for developing or managing the development of analytical methods for analysis of combination biotherapies..

Hopewell, New Jersey, United States

- Acted as the Analytical Team Lead for an Early Candidate Nomination (ECN) and a marketed product. Duties included reviewing of analytical sections in an IND filing and reviewing of analytical data to be included in document submissions to worldwide Regulatory Agencies.- Responsible for developing challenging chromatographic analytical methods for.

Bloomsbury, NJ

*Responsible for managing method remediation activities of marketed products. Duties include determining the impact of critical method parameters on the final result and finding solutions for managing those impacts, developing and managing timelines and providing updates to upper management. Responsibilities include managing one employee’s day to day.

*Develop and /or improve analytical methods for characterization of protein drugs and impurities using appropriate analytical technologies such as SEC, peptide map, reverse-phase, hydrophobic interaction and ion exchange chromatography*Responsible for writing technical documents such as method development reports, technical reports, test reports, standard.

*As an individual contributor or as a team member, develop and /or improve analytical methods for characterization of protein drugs, impurities, and raw material using appropriate analytical technologies* Recently developed new analytical methods which include assays for the determination of polysorbate 80 and mannitol/sucrose in multiple monoclonal.

* Lead person for the setup and execution of a multi-million dollar study to produce reformulated clinical grade material under cGMP requirements using a Pall Life Sciences ADAM TFF workstation * Protein purification utilizing ultrafiltration/diafiltration techniques* Purification of recombinant proteins by ion-exchange, hydrophobic interaction, size.