-In this strategic, director-level role, I collaborate across functional CMC teams to lead Cell Therapy CMC programs from pre-clinical to clinical stage-Coordinate in close concert with stakeholders from Process Development, Analytical Development, Quality, Regulatory Affairs, and MSAT and Manufacturing to ensure strategic and operational alignment-Partner with CMC Project Managers to map project timeline, budget, resources, and risks/mitigations to ensure timely progression of the program and its deliverables-Align individual stakeholder projects with overarching program goals and strategic objectives of the organization-Ensure all CMC program activities comply with health agency regulations

-Provide strategic, technical, and scientific leadership to Cell Therapy analytical development team, fostering innovation and operational efficiency. -Accountable for analytical team’s operations and implementing strategies to enhance operational efficiency. -Lead CMC management with a focus on stability, comparability, and compatibility from conception through execution. -Oversee the platform testing team, drive analytical testing support for process development, product characterization and stability/comparability programs. -Oversee analytical data management, integration, and archiving. Develop and implement strategies for data visualization. -Build robust processes to guide analytical leads for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings.-Function as an analytical lead for selected program(s), providing strategy and driving pipeline development as part of the product team. -Review/approve study protocols and reports, manage internal and QA review and incorporate regulatory documents. -Collaborate closely with other key line functions and communicate complex data/decisions within department and cross functionally.-Responsible for integrating scientific/technical efforts around cross-functional issues.-Mentor and develop team members, fostering a culture of excellence and continuous improvement.

-Manage in-house operational activities including method development, method pre-qualification, and routine testing across multiple assay platforms (multicolor flow cytometry, cell-based potency/viability assays, ELISA, U/HPLC, Western Blot); manage analytical/QC testing for process development and research teams.-Drive analytical activities at third party CRO/CMO labs including method development and qualification, stability studies and release/characterization testing; collaborate with third party CMO labs to execute GMP manufacturing and stability campaigns for raw starting materials; collaborate with Quality Assurance to set appropriate specifications for drug product and raw material APIs.-Author/co-author internal protocols, reports, and sections for pre-IND and IND dossiers to support regulatory filings in US; support draft responses to information requests (IRs) from the agency; collaborate with regulatory team to support ex-US filings.-Actively manage 3 direct reports and extensively coordinate activities across multiple team members in a matrix-based environment; foster career development for all direct reports.

-Lead analytical development, process development and related activities for clinical phase programs in order to advance company product portfolio.-Manage and execute hands-on laboratory analytical work including development of product-specific ELISA, HPLC, host-cell protein, binding potency and cell potency assays. Support cell line development, upstream and downstream process development activities.-Manage analytical activities conducted at third party CRO/CMO labs including method development and qualification/validation, stability studies and release testing.-Provide data and input for regulatory filings and participate in the design of specifications.-Actively collaborate and support analytical needs across diverse company projects in a matrix environment.

-Developed clinical PK and biomarker assays in a GLP-compliant lab to support clinical phase and post-market studies across multiple therapeutic programs; supported phase-appropriate assay qualification and validation efforts-Developed and qualified a diverse repertoire of critical reagents in support of PK, immunogenicity and biomarker ligand-binding assays.-Purified MAbs, polyclonal antibodies and other therapeutic proteins using chromatographic techniques including Protein A/G, affinity, SEC, IEC and desalting; produced antibody and protein conjugates to dyes and other biological tags.-Characterized purified molecules using a variety of analytical platforms including HPLC, SDS-PAGE, Native PAGE, IEF and SPR.-Managed relationships with CROs and lead multiple outsourced reagent development projects including mouse hybridoma, rabbit/primate polyclonal and phage display platforms.-Managed laboratory activities for research associate level staff members (two direct reports).-Wrote and reviewed technical reports and SOPs; interfaced with QA/QS and Validation teams to ensure adherence to quality standards.

Drive optimal product portfolio development through a variety of approaches, including market analysis, portfolio strategy development, opportunity identification, product lifecycle management and new product introductions.

Lead a team of scientists who develop and produce antibody and molecular assay products for detection of cell signaling and cytokine proteins.-Managed production and QC activities across a portfolio of >1000 antibody and assay products for the interrogation of molecules involved in diverse cell and disease processes.-Product range included standalone antibodies, solid phase sandwich ELISA, competitive ELISA, planar antibody arrays, cell proliferation/cell viability and apoptosis assays.-Directed scale-up efforts resulting in efficient production of >300 antibody/kit lots per year.-Researched and implemented an in-house process for lyophilization of antibodies across a major product line, improving product stability.-Formulated and executed strategic planning initiatives in consultation with senior management, improving efficiency and operations.

Independently managed production and validation efforts for over 200 antibody products sold for detection of total and activation state-specific proteins across numerous cell signaling pathways.-Purified polyclonal and monoclonal antibody materials using protein A/G and peptide affinity methods.-Assesed antibody activity using western blot, immunoprecipitation and ELISA assays. Interfaced with core technology groups to test products in flow cytometry, IF, IHC and chromatin IP assays.-Cultured > 20 adherent and suspension cell lines on a routine basis. Performed cytokine and growth factor treatments for target specific activation; performed transient transfection of mammalian cell lines. Generated cell extracts under native and denaturing conditions for use in antibody validation assays.-Provided detailed technical support to hundreds of customers in academia, biotechnology and pharmaceutical industries.