Senior / Manufacturing Manager

OBJECTIVES: The Senior Manufacturing Manager is a key leadership position responsible for overseeing and optimizing the manufacturing operations of drug substance within ACES manufacturing facility. This role demands extensive experience in biopharmaceutical manufacturing, strategic oversight, and a deep understanding of the complexities involved in vaccine production. The incumbent will lead a team associates, ensuring the successful delivery of high-quality vaccine products while driving operational excellence and continuous improvement. RESPONSIBILITIES: Strategic Leadership and Team Development: Lead and manage manufacturing teams within drug substance operations, ensuring alignment with the company’s strategic objectives. Develop and implement a comprehensive talent management strategy, including succession planning, performance management, and staff development in partnership with HR. Provide mentorship and guidance to manufacturing team, fostering a high-performance culture that emphasizes collaboration, innovation, and accountability. Operational Excellence and Process Management: Oversee the entire manufacturing lifecycle, from upstream ( cell culture, fermentation) to downstream processing (purification, BDS filtration)), ensuring seamless integration across functions. Lead initiatives to optimize manufacturing processes, reduce cycle times, and increase production efficiency while maintaining the highest standards of quality and compliance. Drive the implementation of lean manufacturing principles and continuous improvement methodologies across the production environment. Cross-Functional Collaboration and Project Leadership: Serve as a key liaison between DP manufacturing, R&D, Technical Services, Quality, Regulatory Affairs, and Supply Chain teams to facilitate the successful transfer of new products and processes from development to CTM production. Lead cross-functional teams in the execution of complex projects, including process validation, technology transfer, and the scaling up of manufacturing operations. Provide strategic input on manufacturing capabilities during the early stages of product development, ensuring alignment with long-term program goals. Compliance, Quality Assurance, and Risk Management: Ensure all manufacturing operations comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and company policies. Participate in the development and implementation of quality systems and procedures to monitor and improve product quality, including the management of deviations, CAPAs, and change controls. Lead the preparation and execution of regulatory inspections, audits, and quality assessments, ensuring readiness and adherence to industry standards. Develop and implement risk management strategies to identify, assess, and mitigate potential risks associated with manufacturing operations, including supply chain disruptions and process variability. Capacity Planning and Resource Management: Oversee capacity planning and resource allocation to meet production demands and ensure timely delivery of vaccine drug products. Partner Supply Chain and Procurement teams to ensure the availability and quality of raw materials, components, and consumables required for production. Lead efforts to enhance manufacturing flexibility and scalability, including the adoption of new technologies and the expansion of manufacturing capabilities. Facility and Equipment Oversight: Collaborate with Facility and Engineering teams to oversee the maintenance, calibration, and qualification of manufacturing equipment and infrastructure. Lead the commissioning, validation, and integration of new manufacturing equipment and technologies, ensuring they meet operational and regulatory requirements. Ensure the facility is compliant with all environmental, health, and safety regulations, fostering a safe and sustainable work environment. Data-Driven Decision Making and Performance Metrics: Utilize data analytics to monitor and optimize manufacturing performance, including yield, throughput, and quality metrics. Develop and report on key performance indicators (KPIs) that measure operational efficiency, product quality, and compliance. Lead initiatives to incorporate advanced data management systems and manufacturing intelligence tools to drive decision-making and operational improvements. Innovation and Future Trends: Stay abreast of industry trends, emerging technologies, and regulatory changes that may impact vaccine manufacturing. Provide thought leadership on the future direction of vaccine manufacturing, including the potential adoption of advanced manufacturing technologies such as continuous processing, automation, and single-use systems. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor Degree in Life Science or Engineering with more than 10 years of experience in manufacture of vaccines and therapeutic proteins (recombinant experience preferably) with 5 years in leadership role. Extensive knowledge of drug substance t manufacturing processes, with a strong focus on vaccine production or biologics production Proven track record in process optimization, technology transfer, and scale-up of biopharmaceutical products. Deep understanding of GMP regulations, quality systems, and regulatory compliance systems. Exceptional leadership, communication, and problem-solving skills. Experience in managing regulatory inspections, audits, and cross-functional project teams. Highly motivated to lead by example and passionate about Hilleman Laboratories Mission and Vision Demonstrated the ability to lead and to function in a collaborative/team-oriented production environment Ability to communicate effectively and connect with all levels of the organization Strong leadership and people management skills Require excellent written/oral communication Develop and nurture an organizational culture encompassing agility, innovation, trust, integrity, respect and collaborative spirit. Impressive executive presence and engaging personality, with ability to interface professionally with key stakeholders, Board of Directors. Team builder with a highly collaborative leadership style; ability to build / lead cohesive, high performing program teams. Self-starter with a passion to achieve results with proven ability to generate high quality, on-time results. Creative with strategic problem-solving skills. Strong multi-tasking and prioritization skills.