Senior Manager, Manufacturing Process Support

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY:

The Senior Manager, Manufacturing Process Support is responsible for product technology transfer, compliance, process, systems, training, and process optimization oversight while supporting the site’s manufacturing deliverables and batch success goals. The Senior Manager, Manufacturing Process Support will lead a team of supervisors and managers, ensuring that manufacturing operations are enabled to deliver batches on time and in full (OTIF) while maintaining the highest standards of quality and compliance.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

Supporting Manufacturing & Site Deliverables

• Drive batch success by ensuring technical readiness, process reliability, and operational efficiency.
• Partner with Manufacturing, Quality, and MSAT to proactively remove roadblocks, troubleshoot issues, and streamline workflows.
• Ensure manufacturing operations are fully enabled to execute batches on time and in full (OTIF) by optimizing scheduling, resources, and technical support.
• Implement strategies to reduce deviations, improve cycle times, and enhance process reliability.

Technology Transfer & System Ownership

• Act as System Owner for technology transfers, ensuring seamless integration of new processes and equipment into manufacturing.
• Lead cross-functional collaboration between MSAT, Engineering, and Manufacturing to ensure successful transfer, validation, and scale-up of new products.
• Own and optimize process control strategies to ensure efficient and compliant execution of manufacturing processes.

CAPA, Change Control & Compliance Oversight

• Initiate, track, and own Manufacturing-related CAPAs and Change Requests (CRs) to support continuous improvement and regulatory compliance.
• Conduct risk assessments and deviation investigations, ensuring corrective actions are effective, sustainable, and prevent recurrence.
• Ensure GMP compliance and regulatory alignment, proactively addressing quality risks before they impact batch execution.

Training & Team Development

• Lead and develop a team of supervisors and managers, fostering a culture of technical excellence, accountability, and continuous improvement.
• Oversee training programs, ensuring Manufacturing teams are proficient in SOPs, best practices, and regulatory requirements.
• Ensure training effectiveness through ongoing assessments, upskilling programs, and hands-on coaching for the operations team.

 Manufacturing Floor Support & Troubleshooting

• Provide real-time, hands-on support to Manufacturing teams during production runs, troubleshooting technical issues and deviations.
• Ensure proper performer-verifier alignment, confirming only trained and qualified personnel are executing critical process steps.
• Serve as a technical escalation point, ensuring rapid issue resolution to minimize batch disruptions.

Cross-Functional Collaboration & Continuous Improvement

• Work closely with Engineering, Quality, Supply Chain, and MSAT to drive operational excellence and process optimization.
• Develop and implement continuous improvement initiatives to increase throughput, reduce waste, and enhance process efficiency.
• Lead efforts to improve facility fit, process monitoring, and manufacturing control strategies to support long-term operational success.

SKILLS

• Communicates complex ideas, anticipates potential objections and guides/persuades others, often at senior levels, to adopt a different point of view.
• Assimilates feedback from other teams to achieve successful work processes within the function/group.

QUALIFICATIONS

Required:

• BS/BA degree with 10 years of industry experience, or Master’s degree with 8 years of industry experience. Equivalent education and experience may substitute for stated requirements.
• 3 years’ experience in a leadership role
• Proven expertise in technology transfer, compliance management, process troubleshooting, and team leadership.
• Strong understanding of GMP regulations, batch execution requirements, and process control strategies.
• Ability to drive batch success and manufacturing excellence through cross-functional collaboration and proactive issue resolution.
• Excellent leadership skills, with experience mentoring and developing supervisors and managers.
• Strong project management skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.

COMPENSATION:

$124,320 - $170,940

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Salary : $124,320 - $170,940