Head of Manufacturing, Sterile Injectables

Kelly® Science & Clinical is seeking a Head of Sterile Manufacturing for a direct hire opportunity with a leading specialty pharmaceutical company in Sacramento, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Position Title: Head of Sterile Manufacturing

Position Type: Direct hire

Overview

Join an innovative global pharmaceutical organization dedicated to transforming healthcare through high-quality, affordable prescription and over-the-counter medications for North America. With over a decade of proven success, we combine advanced technology, integrated supply chains, and a commitment to operational excellence—all to improve patient access and outcomes. Our workplace is collaborative and growth-oriented, offering competitive pay, comprehensive benefits, and robust professional development. Here, your talent will drive both business innovation and tangible improvements in patient care.

Our client's Sacramento manufacturing site is a center of excellence for sterile product production, specializing in vials, pre-filled syringes (PFS), and IV bags. As a leader in the field, they are known for setting industry standards in safety, quality, and efficiency—all with the mission to elevate healthcare for the communities they serve.

We are seeking an accomplished and strategic Manufacturing Head to oversee our sterile manufacturing operations for vials, pre-filled syringes, and IV bags. In this pivotal leadership role, you will steer a dynamic team, shaping the future of sterile manufacturing in a highly regulated environment. Your impact will ensure our facility not only meets but surpasses industry and regulatory standards for quality and safety, driving operational excellence and efficiency while supporting product innovation.

Responsibilities

• Direct all aspects of sterile manufacturing for vials, PFS, and IV bags—ensuring consistent achievement of production targets and uncompromising compliance with global regulatory standards (cGMP, FDA, EMA, etc.).
• Collaborate with Quality Assurance and Regulatory Affairs to implement and maintain the highest aseptic processes and product quality, minimizing risk and maximizing batch consistency.
• Drive continuous improvement programs to optimize resources, enhance production output, and sustain best-in-class manufacturing practices.
• Cultivate, mentor, and elevate a high-performing team, reinforcing stringent aseptic and cleanroom standards while championing ongoing training and development.
• Lead equipment and process validation for new technologies and sterile fill lines, delivering seamless transfer from development to production.
• Oversee the manufacturing budget, identify opportunities for cost efficiency, and maintain safety and product quality as top priorities.
• Work cross-functionally with R&D, Engineering, and Supply Chain teams to support new product launches, resolve production challenges, and streamline workflow.

Qualifications

• Bachelor’s degree (Engineering, Pharmaceutical Sciences, or related discipline required; Master’s preferred).
• 15+ years’ experience in sterile manufacturing leadership, ideally with vials, PFS, or IV bags in a highly regulated setting.
• Deep expertise in cGMP, FDA, EMA guidelines, and sterile manufacturing best practices.
• Advanced knowledge of aseptic technique, environmental monitoring, and cleanroommanagement.
• Inspiring leader, adept in team development and fostering a culture of excellence.
• Analytical thinker skilled in data-driven decision-making and risk management.

Total Rewards

• Annual performance bonus
• Comprehensive health, dental, and vision coverage
• Paid time off
• 401(k) with company match
• Strong culture of learning, inclusion, and career growth

Our Commitment

We’re committed to building a diverse, inclusive, and accessible workplace. All qualified candidates are encouraged to apply—including those who may not meet every requirement. We prohibit harassment and discrimination of any kind and are proud to be an equal opportunity employer.