Joseph Connolly Email & Phone Number

Boston, MA, US

Cambridge, MA, US

Cambridge, MA, US

• Oversight of all analytical CMC activities at external vendors for biologics (mAb, bispecifics, Fc-fusion proteins), including both drug substance (DS) and drug product (DP).
• Leads development of a phase appropriate, analytical control strategy for biologics (mAb, bispecifics, Fc-fusion proteins) including identification of the quality target product profile and critical quality attributes.
• Manage selection, method development, assay transfer, qualification and work carried out by contract research and manufacture organizations.
• Oversee all QC activities at CDMOs producing cGMP DS and DP including development, verification, qualification, and validation of analytical methods.
• Authors and reviews CMC sections of regulatory submissions e.g., IND, BLA and supportive source documents.
• Leads and participates in cross-functional CMC program teams for biologics. Represents CMC in company-wide program teams.

Lexington, Massachusetts, US

• Led the Analytical and Process Development team of eight scientists to meet and exceed corporate goals in Neoantigen Cancer Vaccine program while mentoring and advocating individual team members to achieve their.
• Developed and implemented scientific strategies for Analytical Development using state-of-art methods to support accelerated biologic product development, characterization, CQA assessment, comparability following.
• Managed resources and progress of Process Development activities, with both internal and external teams, ensuring the CMC group anticipates and meets challenging clinical demands.
• Oversaw the selection, resource management, and technical supervision of CROs and CMOs. Maintains a balanced use of internal and external resources to ensure maximal efficiency and prioritization of programs all while.
• Authored, reviewed, and approved CMC sections in IND filings for several cancer vaccine programs.
• Interacted effectively and transparently with the Manufacturing and Quality Control teams, in supporting tech-transfer activities, process improvements and implementation, investigating out-of-specifications.

Lexington, Massachusetts, US

• Prepared CMC section in successful Phase 1 IND submissions for several therapeutic checkpoint mAb programs (CTLA-4, GITR, OX40, PD-1) as well as therapeutic cancer vaccines.
• Collaborated with Process Development to ensure strong cross-functional collaborations and integrated product development and characterization.
• Assessed mAb developability and manufacturability through the identification and quantification of Critical Quality Attributes (CQA) such as deamidation, oxidation, and isomerization levels of mAb candidates. Led.

Lexington, Massachusetts, US

• Provided analytical oversight and guidance to external partners (CMO/CRO) during mAb GMP manufacture. Coordinated with internal and external teams to generate Certificate of Testing (CoT) for pre-clinical and clinical.
• Supervised scientists in the characterization of mAb and other biologics by UPLC, SEC, CGE-SDS, mass spectrometry, Octet, and cIEF.
• Developed and implemented mass spectrometry methods to generate characterization data used in CMC IND submissions of multiple therapeutic mAb-based products (IgG1, IgG2, and IgG4). Biophysical characterization included.
• Demonstrated cross-team collaborative capacity with Research, Manufacturing, CMC Management, Program Management, and Quality (QC and QA) groups.
• Developed and executed, in a cGMP environment, analytical QC release test methods for peptide and protein drug products in support of Phase 1 and 2 clinical studies.
• Prepared and reviewed technical reports, research methods, standard test methods, and standard operating procedures.

US

• Supported CMC activities involving areas of mass spectrometry, peptide mapping, and advanced analytical characterization.
• Analyzed peptide drug substances (API) and peptide drug products by LC-MS following ICH guidelines to assess lot-to-lot reproducibility of manufacture.
• Provided technical and analytical support involving cGMP mass spectrometry analysis with CROs as well as reviewed and approved reports from CROs.
• Interacted directly with CMO to optimize ion exchange in downstream processing of peptide drug substances.
• LC-MS method development, method validation, and method transfer in compliance with regulatory agency (FDA, ICH, USP) guidelines for improved structural confirmation of peptide drug substance.
• Method development of in-process intermediates and final peptide drug substances using MALDI-TOF mass spectrometer.

• Developed analytical LC-MS/MS MRM methods to quantify antigen protein levels in vaccine.
• Using MALDI-TOF and 2D gel electrophoresis, identified antigens from bioterrorism agents, (e.g., Bacillus anthracis, Francisella tularensis) which were incorporated into vaccine formulations.
• De novo sequenced proteins and peptides by LC-MS/MS.
• Identified proteins in complex mixtures by LC-MS/MS and Mascot database searching.
• Oversaw the operation of the Proteomics Laboratory including scheduling/prioritizing of experiments, development of procedural guidelines, analysis of MALDI-TOF MS and LC-MS/MS data, and presentation of data to.
• Purified recombinant proteins by affinity chromatography.

Burlington, Vermont, US

• Developed a high-throughput screen using differential X-ray crystallography to identify pharmacological lead compounds.
• Purified highly pure recombinant non-tagged protein by ion-exchange chromatography.
• Solved X-ray structures to high resolution using molecular replacement.

Ph.D., Biochemistry

B.S., Biochemistry