Manager, Upstream Manufacturing

JOB SUMMARY

The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment. This role ensures equipment and material readiness, media preparation, cell culture, infection processes, and execution oversight while maintaining strict compliance with regulatory requirements. The incumbent will lead a team of manufacturing professionals, drive operational excellence, collaborate with other SMEs, ensure inspection readiness, and deliver safe, compliant, and reliable production in alignment with site objectives.

• Provide direct leadership and oversight of upstream manufacturing operations including media preparation/transfer, cell culture, infection, harvest, and associated process steps.
• Ensure full readiness of equipment, materials, and personnel to support production schedules and batch execution.
• Lead and oversee all aspects of execution on the manufacturing floor, ensuring adherence to batch records, SOPs, and CGMP requirements.
• Own and manage Quality Management System (QMS) elements including deviations, CAPAs, change controls, and investigations.
• Ensure all documentation (batch records, logbooks, and supporting records) is accurate, complete, and inspection-ready.
• Drive compliance with global regulatory requirements (FDA, MFDS, TGA, and other applicable agencies). Lead people management responsibilities including hiring, coaching, performance management, and development of direct reports.
• Establish a culture of safety, quality, and continuous improvement across upstream operations.
• Oversee cleaning, decontamination, sterilization, and aseptic practices to maintain a compliant manufacturing environment.
• Partner cross-functionally with MSAT, Quality, Supply Chain, Engineering, and QA to ensure successful execution and continuous improvement.
• Drive operational excellence initiatives including cycle time reduction, right-first-time performance, and capacity optimization.
• Support regulatory inspections and audits, ensuring sustained inspection readiness.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

• Bachelor's degree in Life Sciences, Engineering, or a related discipline required (advanced degree preferred).
• Minimum of 7+ years of experience in biopharmaceutical or vaccine manufacturing, with at least 3 years in a leadership role.
• Strong experience in upstream processing including cell culture and viral systems preferred.
• Deep knowledge of CGMP regulations, FDA guidelines, and global regulatory expectations.
• Proven experience managing teams in a regulated manufacturing environment.
• Demonstrated ability to lead investigations, implement CAPAs, and manage complex Quality Systems.
• Strong communication, leadership, and stakeholder management skills.

• Operational leadership and execution focus
• Strategic thinking with strong tactical delivery
• Quality and compliance mindset
• People leadership and team development
• Problem-solving and decision-making under pressure

The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be…