Senior Manager, Manufacturing

As a Senior Manager of Manufacturing, your primary responsibilities will include overseeing both upstream and downstream biologics manufacturing, managing a team of scientists and manufacturing personnel, driving process optimization initiatives, and ensuring compliance with industry standards. You will also develop Standard Operating Procedures for GMP manufacturing, collaborate with various departments, and maintain project timelines.

Candidates for the Senior Manager of Manufacturing role should have a Bachelor’s, Master’s, or Ph.D. in Biochemistry or related fields, with at least 10 years of experience in biologics manufacturing and 5 years in a leadership capacity. Extensive knowledge of monoclonal antibody production and cGMP guidelines is also essential.

The most critical skills for a Senior Manager of Manufacturing include strong leadership abilities, excellent problem-solving capabilities, and robust organizational skills. Additionally, interpersonal communication skills are vital for engaging with stakeholders at all levels, along with a deep understanding of GMP processes and regulatory requirements.

The Senior Manager of Manufacturing contributes to continuous improvement by driving initiatives aimed at optimizing existing and new GMP processes. This includes overseeing technology transfers, batch execution, leading investigations, and ensuring timely resolution of deviations and process improvements throughout the manufacturing lifecycle.

The work environment for a Senior Manager of Manufacturing is dynamic and collaborative, often involving interaction with cross-functional teams such as Quality Assurance, Process Development, and Regulatory affairs. The role demands a clear focus on compliance, operational efficiency, and leading a motivated team in a fast-paced and regulated industry.

Be prepared to discuss your specific roles in monoclonal antibody production, highlighting your experience with cell culture and purification techniques. Mention any particular achievements or improvements you spearheaded in these areas.

Discuss your methods for maintaining cGMP compliance, such as conducting regular audits, training team members, and implementing stringent SOPs to ensure all processes meet industry standards.

Share examples of successful process optimization initiatives you have led, emphasizing the data-driven methods and technologies you employed to achieve measurable improvements in efficiency.

Explain your approach to conflict resolution, focusing on communication, active listening, and your ability to mediate discussions to find mutually beneficial solutions.

Prepare a specific example illustrating the challenge, your approach to resolving it, and the outcome. Use the STAR (Situation, Task, Action, Result) method to structure your response.

Discuss your hands-on experience with technology transfer, highlighting any successful projects where you led the transfer of technology from development through to production.

Describe the communication strategies you employ to keep cross-functional teams aligned and informed, such as regular meetings, status reports, and collaborative tools.

Highlight how you use data analytics to drive decisions, track performance metrics, and identify areas for improvement within the manufacturing process.

Share specific resources or methodologies you use, such as industry journals, conferences, or networking with professionals, to stay informed about changes and advancements in biologics manufacturing.

Articulate your relevant experience, skills, leadership style, and passion for biologics manufacturing. Emphasize how these elements align with the company’s goals and values for the role.