
"Together we are greater,
because great things are rarely the work of one."
JOSEPH m. Valanzuolo
Executive Director of Manufacturing & Operations | Aseptic Manufacturing of Sterile Injectables
Human & Animal Health Products | Small Molecule | Master’s Degree


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Vice President of Pharmaceutical Manufacturing Operations
(Joseph was a direct report of Antonio and later were peers while at Baxter / hikma.)
Companies Joesph has worked for while making a positive impact:
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Professional Roles and Responsibilities
American Regent, Shirley, NY
4/2019 to 7/2024
Executive Director of Manufacturing & Operations, Sterile Injectables
Promoted in April 2019 from Director of Plant Operations.
American Regent, Shirley, NY
10/2015-4/2019
Director of plant Operations, Sterile Injectables
Hikma, Cherry Hill, NY
1/2014 - 9/2015
Senior Manager Prefilled Syringes, Manufacturing
Promoted to provide leadership and technical guidance to project team of 20.
Hikma, Cherry Hill, NY
1/2006 - 1/2014
Senior Manufacturing Manager: Aseptic Filling, Inspection & Packaging
Baxter Healthcare, Cherry Hill, NJ
4/2002 - 1/2006
Process Supervisor of Manufacturing: AsepticFilling & Lyophilization / Inspection & Packaging
Education and Certifications
Center of Creative Leadership
San Diego
5-day immersive Leadership Development Program (2023)
Master of Arts
Strategic Communication & Leadership
SetonHall University, South Orange, NJ
Bachelor of Science
Business Management
Albertus Magnus College, New Haven, CT
yellow Belt
Baxter Six Sigma / Lean Boot Camp


Felix worked with Joseph M. but on different teams
(Felix was Joseph's quality counterpart and worked together as peers at American Regent.)

Accomplishment History
Process Improvement & Efficiency
Implemented and championed Six Sigma program across multiple sites, leading diverse project teams to improve fill-to-release metric by focusing on yield, accountability, right-first-time practices, and ≤30-day lot release & distribution. Successfully reduced fill-to-release metric from 54 days to 26 days, achieving a 50% reduction in time and generating hard savings of $1.7 million over 12 months.


Business Continuity and Strategic Planning
Identified and implemented a plan to qualify alternate suppliers for glass components, transitioning from Gerresheimer in Chicago Heights to Gerresheimer in India, as well as introducing a new glass supplier Bormioli located in Italy over a 12-monthperiod. This strategic plan reduced component variability and improved filling yields by ~15%, resulting in a hard cost savings of $500,000 over the following 12 months.
Innovation
Directed the successful execution of a multi-million-dollar CAPEX project, expanding isolator filling lines and relocating inspection and packaging departments, ensuring zero interruptions to critical manufacturing processes. Spearheaded the transition of the project from concept to approval, securing executive management endorsement in 2020 and overseeing key milestones from 2021 to 2024. Collaborated with the Director of Facilities Management and the Director of Maintenance to manage construction and engineering aspects, resulting in the on-time completion of construction phases.


Quality & Compliance
Directed department heads to collaboratively establish internal compliance expectations to ensure on-time investigation closures, supporting on-time product release and meeting customer demand. Implemented a weekly compliance tracker for managers to monitor employee workloads and compliance adherence. Achieved an improvement in investigations closing within≤ 30 days from 72% to 94% over a 12-month period.
Manufacturing Depth & Flexibility
Enhanced inspection and packaging depth by revising job descriptions and implementing a training qualification plan, ensuring 100% of packers, inspectors, machine operators, and leads obtain manual inspection qualification. This initiative addressed the initial 50% skill gap and established consistent inspection rates aligned with qualifications, improving technical competency and operational efficiency in the inspection department.


Operational Excellence
Established right-sized product lot batches to optimize filling operations, allowing for the completion of filling within the two-shift, 16-hour required run time. This resulted in an 11% reduction in bulk discards and a 10% increase in filling yields for 187 product lots over a 12-month period.
Workplace Culture and Recognition
Fostered a robust partnership mutual respect and alignment with quality management by scheduling regular meetings, maintaining open communication channels, and aligning goals to ensure seamless operations. Facilitated joint training sessions and workshops to enhance mutual understanding and expertise. Promoted joint problem-solving and continuous improvement initiatives through cross-functional teams. Recognized and celebrated the contributions of quality management to reinforce their importance.


Operational, Capital and CAPEX Budgets
Spearheaded the integration of finance for all capital expenditure request (CAR) processes to ensure comprehensive stakeholder collaboration and informed decision-making.Established internal protocols for early involvement of finance in planning both scheduled and unplanned capital projects, resulting in streamlined approvals and enhanced budget management. Achieved a 20% reduction in CARapproval time and improved financial forecasting accuracy by 15%.
Leadership, Technical Acumen Development, Succession Planning
Developed and implemented the 21 Irrefutable Laws of Leadership Development Series for managers as well as hourly workforce over a 10-month period, designed to explore how we can enhance our leadership qualities at all levels in the organization. Although the employees who participated had a robust understanding of essential leadership principles and practical skills to apply these laws, the development of relationships was remarkable.


Personal Development
Attended the annual Parenteral Drug Association (PDA) conference, a leading global provider of science, technology, and regulatory information, to stay current with industry advancements. Participated in sessions designed to create awareness and understanding of critical issues facing the pharmaceutical and biopharmaceutical community. Engaged in high-quality, relevant educational opportunities to enhance knowledge in pharmaceutical/biopharmaceutical manufacturing science and regulation, supporting the mission to better serve patients.