Job Title: Associate Director of MSAT
Job Number: 33336
Location: San Diego, CA
Support CMC operations, focusing on tech transfers, process development, manufacturing operations and regulatory documentation.
• Take on a leadership role in the technical aspects and collaborate across teams to ensure effective communication, serving as an expert to explain and present scientific information and data regarding cell therapy and/or exosome platforms.
• Ensure that all technology transfers into the manufacturing process adhere to regulatory guidelines for Good Manufacturing Practices (GMP).
• Support the Manufacturing group by addressing and resolving production issues to ensure the safe, high-quality, and timely production of biopharmaceutical products for pre-clinical, clinical, and commercial purposes.
• Develop and review manufacturing Standard Operating Procedures (SOPs) and documentation (batch records, SOPs, bills of material, tech transfer documents, risk assessments, and process flow diagrams) to ensure that all clinical products meet the required standards for quality, safety, and effectiveness.
• Investigate manufacturing deviations or conduct experiments to determine the root cause of issues.
• Provide on-site and real-time support during manufacturing production as necessary.
• Contribute to strategic planning for resource allocation and capacity management at the site, taking into account the demand for both cell therapy and/or exosome platforms in clinical and commercial settings.
• Identify and implement opportunities for process improvements and corrective actions to increase yield, optimize capacity, enhance operational efficiency, reduce costs, and maintain regulatory compliance in collaboration with Research & Development (R&D) and manufacturing teams.
• Evaluate new technologies and explore innovative applications of existing technologies that could be implemented to improve the company's products and processes.
• Collaborate closely with the Quality department to ensure compliance with regulatory standards such as current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH), and FDA regulations.
• Act as a catalyst for organizational change, fostering an environment of critical thinking, empowerment, and a commitment to error prevention and continuous improvement.
• A Bachelor's degree is required (a Master's or PhD is preferred).
• Minimum of 8 years of hands-on experience in cGMP cell therapy manufacturing within the pharmaceutical/biotech industry.
• At least 5 years of direct management experience overseeing manufacturing professionals, with a progressive increase in responsibilities.
• Excellent communication and interpersonal skills.
• Proficiency in collecting and analyzing data and information to identify opportunities for process improvement and potential root causes.
• Demonstrates technical expertise, scientific creativity, problem-solving abilities, a strong understanding of Good Manufacturing Practices (GMP), and the ability to collaborate effectively with others.
• Thorough knowledge of cGMP regulations is essential.
• A solid scientific background with extensive knowledge of biologics is required, and experience in cell therapy and nucleic acid (mRNA) is advantageous.
• Strong communication and interpersonal skills.
• Ability to thrive in a dynamic environment, handle multiple tasks, and prioritize work effectively.
• Demonstrated critical thinking and problem-solving skills.
• Full understanding of cGMP regulations.
• Strong scientific background with in-depth knowledge of biologics and cell therapy. Molecular biology experience is a beneficial addition.
Compensation and Benefits:
Salary range: $140,000-160,000/year
Health Insurance (medical, dental, vision)
Short- and Long-Term Disability
Paid Time Off (PTO)
To apply for this job please visit k7y.pl.