Associate Director of Manufacturing

Associate Director of Manufacturing

Permanent role, fully onsite in Orange County

Relocators are welcome

No visa sponsorship

Our client is a fast-growing pharmaceutical manufacturing organization specializing in sterile drug product and aseptic fill/finish operations within a highly regulated GMP environment. Due to significant growth and an expanding portfolio of new client projects, the company is adding key leadership talent to support increasing manufacturing demands and operational scalability. The organization is known for its collaborative, close-knit culture where employees work together in a supportive, team-oriented environment focused on continuous improvement and operational excellence. Leadership is highly invested in employee development, creating strong opportunities for career growth, internal advancement, and long-term professional success. This is an opportunity to join a company experiencing rapid momentum while playing a critical role in shaping manufacturing operations and team performance.

The Associate Director of Manufacturing will provide both strategic leadership and hands-on operational oversight for aseptic fill/finish manufacturing activities in a GMP-regulated pharmaceutical environment. This role will lead manufacturing supervisors and support a growing team responsible for sterile drug product operations. The position requires a highly technical leader with deep expertise in aseptic processing, fill/finish manufacturing technologies, and human performance best practices within sterile manufacturing environments. This individual will play a critical role in strengthening operational execution, supporting team development, improving aseptic behaviors, and driving manufacturing efficiency as the organization scales. The ideal candidate is a collaborative and dedicated leader who thrives in a fast-paced environment and is passionate about building strong teams while remaining actively engaged on the manufacturing floor.

Job Duties

• Lead daily GMP-compliant aseptic fill/finish manufacturing operations while ensuring safety, quality, compliance, and production schedule adherence.
• Provide technical leadership and hands-on support for drug product manufacturing processes including vial lines, syringe lines within RABS, cartridge lines, and manual filling equipment.
• Guide and reinforce best practices in aseptic processing, cleanroom behaviors, airflow principles, contamination control, and operator human performance.
• Supervise and mentor manufacturing leadership staff, including two manufacturing supervisors and their associated production teams, while supporting employee development and workload management.
• Oversee manufacturing documentation and quality systems activities including batch records, SOPs, deviations, CAPAs, change controls, and validation support.
• Partner cross-functionally with Operations, Quality, Engineering, and Validation teams to support new client projects, process improvements, equipment implementation, and operational scalability.

Job Requirements

• Bachelor’s degree in Chemical Engineering, Biology, Life Sciences, or a related scientific discipline required; Master’s degree preferred or equivalent relevant experience.
• 10–12 years of experience in pharmaceutical drug product manufacturing, including a minimum of 5 years in a manufacturing leadership or people management role.
• Strong technical expertise in aseptic fill/finish operations and sterile manufacturing processes within GMP-regulated environments.
• Proven experience with manufacturing technologies including vial lines, syringe lines within RABS, cartridge lines, and manual filling equipment.
• Deep understanding of aseptic practices, contamination control, cleanroom operations, cGMP regulations, FDA requirements, and DEA compliance standards.
• Strong leadership, communication, coaching, and team-building skills with the ability to thrive in a collaborative, fast-paced, growth-oriented culture.

Contact

If you're interested, apply to this job post and reach out to Amit at [email protected] to contact us directly.