Senior GxP Program Manager, PMP, Agile

Robin Caputo MA, LATg, PMP

Milford, Massachusetts 01757 ************@*****.***

LinkedIN: https://www.linkedin.com/in/robincaputo2

Summary

Creative and adaptable Senior Program Manager with 17 years of experience in the Pharmaceutical and Life Sciences industries, who is known for implementing and promoting streamlined procedures and process improvements for efficiency and consistency within GxP environments. Demonstrated accomplishments in managing complex, high visibility projects in drug and medical device arenas, bringing them to completion on time and within budget; balancing relationships diplomatically while negotiating deadline conflicts. Superb scientific and interpersonal writing and communication skills. Skilled in creating and maintaining complete project plans, schedules, and budgets for lab build out projects. Expertise includes, Program and Change Management, Manufacturing transfer, Practical process Improvements, Agile, Lean, and working under ISO 13485 and ISO 9001 Quality Control regulations. Computer program proficiencies include Teams, PD Ware, MS Project Pro, SharePoint use and design, MS Office, Smartsheets, and Power BI.

Work Experience

10BITS – CONTRACTED WITH PFIZER, Remote December 2024 – February 2025

Project Manager

Managed the integration and transition of a legacy database to a new, internal cyberspace

Managed the training of employees on the new database so that they are ready to use it on day 1 of the transfer

Oversaw the change management required to prepare the team for efficient launch of the project.

ASSAYQUANT TECHNOLOGIES, Marlboro, MA April 2023 – December 2023

Senior Program Manager

Established project management best practices and PMO support for multiple departments.

Managed the development, validation, and implementation of a new data and inventory management system; interfacing with internal resources and an IT CRO.

Developed Smartsheets to track KPI’s across the company, allowing for data-driven continuous improvement; including R&D, Quality Control, Marketing, and Sales departments.

PERKIN ELMER, Hopkinton, MA 2021 – 2023

Senior Program Manager – New Product Introduction

Led a team of internal resources and CRO IT contractors to launch PK Eye, an automated workflow monitoring system for the Janus, Sciclone and Zephyr liquid handling systems.

Managed the development of two new Cannabis Reagents kits for the detection and measurement of pesticides for Cannabis testing labs.

Coordinated cross functional design reviews and risk analysis sessions for multiple projects to identify possible risks and opportunities and put in place plans to avoid issues and take advantage of acceleration opportunities.

Customized Perkin Elmer’s standard Global Product Development process for each project to balance project complexity with required documentation to assure high quality Design History File creation while maintaining focus on speed and efficiency.

Created and maintained project plans, schedules, and budgets utilizing project management software, including PD Ware, MS Project, Smartsheets and JIRA.

Experience working with procurement teams and procurement strategic initiatives in new product development and introductions.

Communicated across multiple teams and global stakeholders in the development of project plans.

THERMO FISHER SCIENTIFIC, Bedford, MA 2017 – 2021

Senior Program Manager – BPD, New Product Development (Purification)

Led an international team to accelerate the development of POROS Capture Select AAVX resin NPI to launch four months ahead of schedule, resulting in significant company savings and timely fulfillment of acute customer demand.

Brought POROS Ethyl, POROS Benzyl, and POROS Benzyl Ultra NPI’s back on schedule to launch on time, in full, with full compliance to company procedures and industry best practices, resulting in a zero non-conformity resolution of the corporate project audit.

Oversaw the manufacturing transfer of 6 resin lines, including CMC and manufacturing process development.

Utilized PPI principles and methods to develop and implement a new QC task tracking system to reduce the average backlog of QC testing fulfillment at the Bedford, MA site.

Provided Program Management expertise for Thermofisher Scientific’s Purification Customs program, launching three custom resins for diverse pharmaceutical companies.

Designed new iConnect Sharepoint sites and performed training for end users to facilitate enthusiastic user acceptance; increasing cross functional communication and efficient collaboration within multiple project teams.

Selected to become a Certified Engaged Process Manager; leading Practical Process Improvement Kaizens to drive continuous improvement in multiple work centers across the company.

Instructed team members in the theory and execution of Thermo Fisher’s Product Commercialization Process (PCP)

Managed a change in the NPI team to reduce paperwork and enhance the Stage Gate procedure.

Provided Project Management training and mentoring to Operations and R&D colleagues to assist in their professional development within Thermo Fisher Scientific and promote best-in-class project management standards.

Experienced in working under ISO 13485:2016 and ISO 9001 Quality Control regulations.

QIAGEN, Waltham, MA 2015 – 2017

Senior Project Manager – NGS GeneReader Platform

Managed an international, 20-30 person team of Project Managers, Scientists, Research Associates, and Business Professionals to develop consumables supporting the Next Generation Sequencing GeneReader System, and seamlessly integrate consumables, software and hardware projects into a marketable product.

Coordinated Software, Hardware, and Wetware research & development activities, resource allocation, WBS and budget development, project management documentation and personnel assignments.

Designed and rolled out new collaborative Sharepoint site, as well as creating a full training program for end users to facilitate enthusiastic user acceptance; increasing interdepartmental communication and efficient cooperation.

Assisted in the management of several R&D taskforces, exploring root causing of experimental and manufacturing deviations, identifying corrective and mitigating responses, and implementing change control procedures, utilizing Agile methodology.

BIOGEN, Cambridge, MA 2007 – 2015

Senior Associate Scientist - Drug Metabolism and Preclinical Safety

Managed high visibility project to update Biogen’s DMPS capabilities with the installation of a new suite of DiLab Accusampler automated sampling units, from defining requirements through project closure; leading a team including management, co-workers, finance, vendors, facilities design and construction experts, vivarium personnel, and IT support technicians.

Coordinated DMPS resources to support eight to ten drug development programs per week, assigning personnel and CRO’s to workflows, acquiring test articles, monitoring and facilitating the transfer of samples and data between internal departments, and maintaining supplies and animal resources through computerized ordering and tracking systems.

Managed the development and adoption of new technical capabilities including brain tissue microdialysis, small volume serial mouse blood collection protocols, terminal mouse CSF collection protocols, and serial rat CSF sampling techniques in awake rats, increasing the quality and precision of data while reducing the departmental in vivo budget by 50%.

Selected to join a Project Team with IT department personnel to develop and implement DMPS Workflows within an Electronic Laboratory Notebook format to enhance productivity and information sharing across multiple work groups.

Comprehensive understanding of the drug development and launch process, including experience with oncologic, autoimmune, infectious, and neurodegenerative disease research.

Expert knowledge of vivarium operations, functions, and governing USDA regulations.

Wrote and maintained over 15 IACUC Protocols and SOPs for in-house use and CRO export, according to company guidelines and industry best practices.

Provided supervision and training in basic and advanced in vivo skills for all new DMPS hires.

Honored by IACUC for superb advances in the implementation of the three R’s (Replace reduce refine) in the DMPS program, which resulted in a 65% reduction in overall animal use.

Supported the Drug Metabolism and Preclinical Safety group by performing in vivo PK/PD/ADME experiments, including rodent tissue, CSF, bile and blood sampling, IV, SQ, IP, IM, intrathecal and oral dosing of experimental compounds, performing metabolic studies, survival surgeries, implanting cranial cannulas and microdialysis probes, and operation of Culex and Accusampler automated sampling units.

CHARLES RIVER LABORATORIES, Wilmington, MA 2006 – 2007

Contracted Associate Scientist II, Biogen Idec

Supported the Preclinical Drug Safety department by performing in vivo oncology and PK/ADME experiments, including: xenograft implantation, manual rodent tissue and blood sampling, IV, SQ, IP, IM and oral dosing of experimental compounds, and operation of Culex automated sampling units.bn

Wrote IACUC Protocols, Protocol amendments, and SOPs.

Maintained accurate laboratory notebooks and records.

Maintained animal resources through computerized ordering and tracking systems

Publications

1. MARS: bringing the automation of small-molecule bioanalytical sample preparations to a new frontier. Li M,

Chou J, Jing J, Xu H, Costa A, Caputo R, Mikkilineni R, Flannelly-King S, Rohde E, Gan L, Klunk L, Yang L. Bioanalysis. 2012 Jun; 4(11):1311-26.

2. Cerebrospinal fluid can be used as a surrogate to assess brain exposures of breast cancer resistance protein

and P-glycoprotein substrates. Xiao G, Black C, Hetu G, Sands E, Wang J, Caputo R, Rohde E, Gan LS. Drug Metab Dispos. 2012 Apr; 40(4):779-87.

3. Monoclonal antibody exposure in rat and cynomolgus monkey cerebral spinal fluid following systemic

administration. Wang Q, Delva L, Weinreb P, Pepinsky R, Graham D, Veizaj E, Cheung A, Chen W, Nestorov I, Rohde E, Caputo R, Kuesters G, Bohnert T, Gan L. Fluids and Barriers of the CNS 2018 Mar; 15(1):1.

Education

Master of Arts, Microbiology, Boston University School of Medicine, Boston, MA

Bachelor of Science, Veterinary Technology, Mount Ida College, Newton, MA

Bachelor of Science, Animal Science, Cornell University, Ithaca, NY

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