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 electrophoretic and chromatography-based testing of biologics to support Research & Development (e.g. clinical release and stability, reference material qualification, and product development).*Practical knowledge of analytical techniques which enables development of phase-appropriate, robust and reproducible analytical methods for use in the GxP clinical laboratory.*Oversee analytical method qualifications/validations (as applicable) and transfers of methods to internal and external QC laboratories.*Ensure group is in full compliance of relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures.*Review technical documents, reports and protocols to assure technical merit, accuracy and completeness.*Proactively provide clear, timely communication of potential issues to management.

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.- Developed and successfully implemented a new strategy for performing phase appropriate method validations for combination biotherapies, which decreased the overall timeline by 6 weeks per method.- Analytical single point of contact for multiple Immuno-Oncology programs which includes attending meetings, driving analytical decisions, managing timelines, interacting with CROs and cross functional groups and updating management and team as needed.- Developed a novel method for the analysis of the drug to antibody ratio (DAR) in antibody drug conjugate (ADC) products that was subsequently published in a peer-reviewed journal.- Acting as the Analytical Team Lead for a phase 3 mAb product. Duties include drafting CTA and IND responses to health authority questions. Responsible for drafting and reviewing BLA sections.- Responsible for managing a group of four employees.

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 Antibody-Drug Conjugate (ADC) molecules.- Performed phase appropriate method validations for chromatographic analytical methods.- Subject matter expert for various analytical methods for the authorship and review of registrational dossiers.- Responsible for managing one permanent and two contract employees.

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 activities*Responsible for managing the extinction coefficient testing of all new molecules.*Oversee the external development and qualification of phase-appropriate analytical methods*Responsible for the development and qualification of characterization methods*Write/review/approve protocols and technical reports*Subject matter expert for the authorship and review of registrational dossiers*Ensure that plat forming technologies are utilized where feasible when developing characterization methods for new molecules to reduce development time and lower costs.*Review and approve analytical data from development partners*Work with cross-functional groups to drive project goals to timely completion

*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 test methods, and standard operating procedures*Present seminars related to technical and method development to other departments or collaborating organizations*Responsible for cross-training personnel on developed analytical methods*Acted as lead analytical technical expert for investigation of an out of specification result in a manufacturing process justification run*Authored analytical section and coordinated initial draft response to a deficiency letter from a Health Authority*Ion exchange chromatography analytical subject matter expert for numerous outsourced projects*Developed a new method for the analysis of polysorbate 80 in antibody drug products which was then published in a peer reviewed journal

*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 antibody products and an assay for B vitamins in cell culture media*Responsible for writing technical documents such as method development reports, technical reports, test reports, standard test methods, and standard operating procedures*Duties include performing routine analysis of monoclonal antibody products for release under cGMP requirements*Performing antibody characterization methods including oligosaccharide structure/population by CE-LIF/HPAEC-PAD, monosaccharide structure/population by HPAEC-PAD and amino acid analysis by post column derivatization*Experimentally determine the extinction coefficient of new drug products by HPAEC-PAD*Responsible for writing/performing the validation of a polysorbate 80 analytical method * Present seminars related to technical and method development to other departments or collaborating organizations*Published articles in peer reviewed journals

* 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 exclusion and reversed-phase column chromatography * Protein analysis by analytical HPLC* Analyzed endotoxin levels of water for buffer preparation using LAL (gel clot) procedure* Quantitation of protein using Bradford dye assay* Maintained cell bank area following cGMP guidelines* Develop quantitative assay to measure chlorine residual level ~ 2ppb* SDS-PAGE and IEF Gel electrophoresis.* Western Blot analysis* Utilized GPC to analyze aggregate formation of protein