Director/Senior Director of Manufacturing Science and Technology (MSAT)

AT ATHERSYS:  Our people make the difference.  We owe our success to the passionate, driven and growth-oriented people who have chosen to align their careers with our mission, “Committed to developing therapies to extend and enhance the quality of human life.”

WE ARE SEEKING:  A Director/Senior Director of Manufacturing Science and Technology (MSAT)  to join our team.  In this role, primary responsibilities will be to define and lead the activities of a team responsible for process transfer (external and internal) and process improvement activities. The individual in this role will work with internal and external partners to establish manufacturing technical transfer by providing tactical and strategic technical support to the organization & our manufacturing partners.
RESPONSIBILITIES

Work closely with the Process Development team to ensure the design and scale up of processes, instruments & equipment from the laboratory, through pilot scale are executable by manufacturing operations when moving into full-scale manufacturing.

• Partner with internal & external stakeholders to ensure projects are executed successfully through the transfer, implementation, validation, filing, and licensing of products/processes.
• Position the MSAT team for success through utilization of technical skills and process knowledge to participate and/or lead investigations through to root cause determination and collaborate within the organization to develop and execute effective CAPAs.
• Ensure that Manufacturing operations are set up for success through the provision of high-quality batch records, robust processes and new technology. Anticipate, respond to and resolve issues that arise during production through use of master data, process & product monitoring.
• Establish strategic goals and objectives that drive MSAT responsibilities, organizational performance, and team development.
• Monitor, analyze, optimize, and ensure validation of processes.
• Plan, develop and implement of new process formulas, establish operating equipment specifications and the improvement of manufacturing techniques and new process equipment introduction.
• Encourage the use of Lean concepts, while fostering and advocating a continuous improvement mindset and culture throughout the organization by encouraging experimentation and learning.

Knowledge, Skills & Abilities

Working technical knowledge of biologics platforms & technologies including cell therapy manufacturing, upstream and downstream process technologies, manufacturing operations and process validation in a regulated (GMP)environment.

• Working technical knowledge of biologics platforms & technologies including cell therapy manufacturing, upstream and downstream process technologies, manufacturing operations and process validation in a regulated (GMP)environment.
• Detailed understanding of CMC and commercial manufacturing and related quality systems (change control, deviations investigations).
• Deep process, equipment, automation, validation and technical knowledge.
• Able to think strategically and translate strategies into actionable plans.
• Proven ability to lead teams that drive results and deliver business outcomes.

Education/Experience

• Bachelor’s Degree required (science or engineering).

• Graduate or higher-level Degree is preferred.
• 10-15 years’ experience in the pharmaceutical, biologics, cell therapy or related industry preferred.
• 5-10 or more years people management experience.
• Significant experience in bringing biotechnology equipment and processes from design through to clinical and GMP operations.
• Experience with start-up and validation of manufacturing equipment, utility, and process systems, including requirements for documentation and testing.

Athersys is an equal opportunity employer. Qualified applicants are considered for all positions without regard to age, race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other status protected by applicable law.