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Joseph M. Valanzuolo

"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

Profile Image of Antonio Di Nicola
“I had the pleasure to work with Joe for a few years and witnessed his growth from a technical and leadership standpoint. Joe is very result oriented, with great focus on process and process improvement. He is a hands-on leader that deeply cares for his folks. I have witnessed how he can shape great, cohesive and well functioning cross-functional teams that can achieve outstanding results. I deem the organization that has Joe on board to be fortunate!”
Logo image of Hikma.
Antonio Di Nicola
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:

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.

Site head for multiple-site campus responsible for planning, direction and the coordination of all manufacturing and operational critical activities.  Managed and led critical support departments including validation, maintenance, operational excellence, manufacturing quality engineering, facilities, custodial, and security. Directed aseptic manufacturing processes, including equipment preparation, compounding, aseptic filling, terminal sterilization, inspection, and packaging. Managed operational budget responsibilities including capital and CAPEX for the ARI-NY campus, including a 18,000 ft² addition and 37,500 ft² of interior renovation.
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American Regent, Shirley, NY
10/2015-4/2019
Director of plant Operations, Sterile Injectables
In October 2015, I transitioned to Long Island, NY to assume the position of Director of Plant Operations to provide strategic leadership and technical guidance for the aseptic manufacturing department.
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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.

In January 2014, I was promoted to the position of Senior Manufacturing Manager Syringes/ Medical Devices to provide leadership and technical guidance to a project team to install a new filling suite for pre-filled syringes; and coordinated development, validation and start up efforts.
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Hikma, Cherry Hill, NY
1/2006 - 1/2014
Senior Manufacturing Manager: Aseptic Filling, Inspection & Packaging
In January 2006, I was promoted to the position of Shift Senior Manufacturing Manager to provide leadership and technical guidance to the Manufacturing Department.
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Baxter Healthcare, Cherry Hill, NJ
4/2002 - 1/2006
Process Supervisor of Manufacturing: AsepticFilling & Lyophilization / Inspection & Packaging
I was hired by Baxter to provide key leadership, communication, direction, and organization management for 40-50 non-exempt group leaders, equipment preparation operators, filling, packaging, and support personnel.
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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

CLICK HERE TO VIEW FULL RESUME
Image of Felix Martinson
“I had the pleasure of working with Joe at American Regent as his counterpart in Quality. During our tenure together, we learned from one another and strove for continuing advancement of our organization. Joe was great to partner with, regardless of whether working through a tough technical challenge or a culture initiative. I found that Joe was always willing to listen to different perspectives and ultimately supported decisions based on data  and the patient perspective. If a future opportunity presented itself, I would not hesitate to be on the same team with Joe again.”
Felix Martinson
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.

Testimonials

Quotation marks

"For the past 8 years I've had the honor of working for Joe as a Filling Operator Lead. Joe has been crucial in helping to build a positive, healthy working environment for myself and others. No matter how busy, he always made time to lend an ear whether it was work or personal. Joe always showed that he cared, offering support and guidance when I needed it the most. I am truly thankful to Joe for giving me the voice I did not always realize I had, and for allowing me to be my authentic self. He proved time and time again that always wanted the the best for his team, and those around him."

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Edna Zuluagang
Quotation marks

"Having worked closely with Joe as the Manufacturing Executive Director at American Regent Inc. (ARI), I have witnessed firsthand exceptional leadership and unwavering dedication to excellence. As Jim Rohn said, "The challenge of leadership is to be strong, but not rude; be kind, but not weak; be bold, but not a bully; be thoughtful, but not lazy; ve humble, but not timid; be proud, but not arrogant; have humor, but without folly." Joe embodies these principles fully, making him an outstanding Executive Director and a highly respected leader. During his tenture at ARi, Joe has demonstrated remarkable strength in leadership, always approaching challenges with a bold yet thoughtful mindset. His ability to inspire and motivate his team is unparalleled, fostering a collaborative an inclusive environment where every team member feels valued and empowered to contribute their best."

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Sevika Sataur
Quotation marks

"For the past 6 years I have had the opportunity and pleasure to work closely under Joe. His tireless leadership and unwavering drive for excellence has had an incredible impact on the improvements and growth that have been achieved. His dedication is nothing short of inspiring and his ability to coach others is a rare attribute. Joe has a tremendous ability to judge talent and get the best out of his workers while empowering them to strive for greatness. A natural leader, he has never hesitated to go above and beyond expectations. I am grateful for the opportunities he provided me and know that any organization he is a part of will benefit greatly from his leadership."

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David Hammer
Quotation marks

"Over the course of my 8 years working for American Regent, Joe established himself as a true leader amongst the team. He continously demonstrated that he cared about doing what was best for the company and the people around him. He worked feveishly to build a postivie, team-centric culture that strove for continuous improvement. Joe provided me with invaluable mentorship. He always supported me in my growth within the company , and as an individual in my personal life. I can not thank Joe enough for giving me the opportunity that he did, and believing in me throughout these 8 years. I would not be where I am today had it not been for Joe."

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Richard Perazzo
Quotation marks

"Joe was my manager for over 2 years. I was fairly new to pharmaceutical industry and had scientific background but not much knowledge of manufacturing, felt very fortunate to land on his team. I very much enjoyed working with him on prefilled syringe project which included IQ/OQ and PQ of newly constructed filling rooms and newly installed equipment. Joe always thought every possible scenario of problems and found solutions. Joe led the team to consistently exceed quote month over month. He sets realistic goals and gives clear instructions and feedback. Joe instills pride, confidence, and positive energy in everyone on his team."

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Archana Rathod
Quotation marks

"Over the course of my time at American Regent I had the pleasure of learning from Joe. As Executive Director, Joe used his leadership abilities to not only achieve the goals of the organization but to promote a positive work place culture. Joe has been exceptional mentor to me, someone who challenged me and provided me with opportunities to grow professionally. I am grateful for all of the guidance he provided me with. "

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Marcus Alvarez, MBA
Quotation marks

I have had the privilege of working for and with Joseph Valanzuolo for 10 years in the pharmaceutical industry. As a mentee to Joseph, I have had the pleasure of learning and applying strategies in leadership, strategic thinking, accountability, technical analysis, and innovation principles. Working alongside Joe, we spearheaded a range of projects that spanned diverse areas such as clean room applications and principles, particle monitoring systems, Six Sigma waste reduction projects, Kanban principles, process engineering, and compliance principles. Joe's ability to seamlessly integrate these complex areas into our work is a testament to his deep expertise and innovative mindset. Some of Joe's strongest qualities include, but are not limited to, his exceptional leadership skills and his ability to bring out the best in people."

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Harry Obamije, CLSSGB

If you have any question,

feel free to call 856-577-2868

or send us an email to josephValanzuolo@gmail.com