Director MSAT

Director MSAT

Work Location: Wake County, NC

Summary:

The Director of Manufacturing Science and Technology is responsible for leading and organizing technical and logistical aspects of product development and manufacturing, including pilot-scale operations, to support biopharmaceutical manufacturing needs. This leadership role ensures robust processes, technology transfer, and continuous improvement in a regulated environment.

Responsibilities:

• Lead and coordinate pilot-scale and clinical manufacturing operations, ensuring all materials, equipment, and documentation are in place for reliable production.
• Identify and mitigate technical and logistical risks, proactively resolving issues and implementing corrective actions to optimize manufacturing processes.
• Oversee technology transfer and process validation activities, ensuring comparability between internal and external manufacturing efforts.
• Compile and analyze batch processing data to monitor quality, identify trends, and drive process improvements.
• Direct production planning for formulation development and GLP batches, collaborating with internal and external cross-functional teams to resolve process-related challenges.
• Guide the establishment of robust batch records and manufacturing processes, supporting process development and transfer from R&D to clinical production.
• Drive continuous improvement initiatives across manufacturing workflows, equipment utilization, and operational efficiency to enhance productivity and reduce costs.
• Serve as a key technical representative for manufacturing process activities, providing scientific support, leading root-cause analysis, and ensuring compliance with cGMP regulations.

Qualifications:

• M.S. degree in biochemistry, chemical engineering, bioengineering, or a related technical field with at least 8 years of experience in pharmaceutical manufacturing; or B.S. degree with 10 years of experience in the same field.
• Experience in senior manufacturing or development operations roles within a biopharmaceutical GMP manufacturing environment, including formulation and aseptic fill/finish.
• Proven track record leading successful manufacturing operations and teams for protein formulations and complex formulations.
• Expertise in aqueous phase chemical formulations and experience with a variety of solvents.
• Demonstrated ability to lead cross-functional teams and manage technology transfer and scale-up from pilot to clinical production.
• Proficiency in cGMP manufacturing environments and familiarity with regulations for aseptic fill/finish products, including validation and qualification requirements.
• Minimum 3 years of supervisory experience and ability to effectively lead complex projects and teams.
• Strong skills in using software tools for documentation and execution management (e.g., Smartsheet, SharePoint).

Published Category: Manufacturing & Technical Operations