Director, MSAT

Physical Demands

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

Responsibilities

• Lead a team of scientists, engineers and technical experts to support the launch, scale up and maintenance of late stage and commercial manufacturing processes 
• Establish and maintain performance metrics to measure manufacturing operations. 
• Develop strategies to enhance manufacturing processes, including optimizing processes for investigation, corrective actions and change management for MSAT Projects 
• Implement process improvements based on data analysis and scientific principles including focus on technology, alternate materials, shipping and labeling, and data from continuous process verification 
• Drive the execution of various studies, qualifications and design of experiments related to deviations, process performance, and regulatory needs for commercial products. 
• Develop and drive practices for the transfer of processes from development into commercial manufacturing facilities 
• Coordinate with the operations team to ensure successful implementation of new processes in commercial GMP environments 
• Collaborate with cross functional teams to trouble shoot and resolve technical issues 
• Lead and drive the preparation and review of data to support regulatory submissions 
• Build and mentor the MSAT team ensure the team is equipped with the skills and tools to meet current and future manufacturing needs 

Education & Experience Requirements

• B.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required 
• PhD in Chemical Engineering, Biochemistry or Analytical Chemistry is preferred 
• Minimum of 10 years of experience, with demonstrated success in higher-level decision-making roles
• Experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries 
• 4+ years of people leadership experience 
• Prior experience in regulated, GMP manufacturing operations 
• Strong communication and problem-solving skills 
• Experience in Cell therapy manufacturing preferred 
• Knowledge of automation, continuous process verification, investigation processes, process optimization 

Personal Qualities & Physical Demands

• Highly detail oriented with special attention to quality, compliance and safety 
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize  
• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment 
• Strong interpersonal skills and ability to communicate effectively 
• Ability to work in a collegial and collaborative manner, independently and part of a team 
• Ability to work in a fast-paced start-up environment while following SOPs 
• Highly tolerant and respectful of all team members 
• Strong problem-solving skills with desire to improve upon established processes 
• Ability to work in cleanroom environments and, at times, across various shifts 
• Ability to follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition 
• Occasional need to ascend/descend stairs within workspace; job requires standing/walking