Sr. Manager, MSAT Downstream

Avid Bioservices•Tustin, CA

1d•Onsite

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: Elevate your career by joining us as a Sr. Manager, MSAT Downstream, where innovation meets expertise in a dynamic and fast-paced environment. In this pivotal role, you'll lead a team of dedicated specialists, harnessing your technical prowess to revolutionize our manufacturing processes. Be the catalyst for change, driving continuous improvement and implementing cutting-edge practices to ensure the highest standards of robustness in our manufacturing operations. Your leadership will not only enhance our capabilities but also inspire your team to tackle complex challenges and excel in routine operations. Join us and play a crucial role in shaping the future of manufacturing sciences and technology.

Requirements

Bachelor’s degree in life sciences or production management
8+ years in manufacturing operations or manufacturing sciences within a pharmaceutical or biotech manufacturing organization.
Mandatory experience in biologics
Proven experience working with current Good Manufacturing Practices (cGMP) and ICH Q7A guidelines
In-depth knowledge and understanding of manufacturing processes
Experience with equipment commissioning and validation requirements
Familiarity with executing process transfer into a manufacturing setting
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Responsibilities

Spearhead a team of technical specialists, fostering their growth and expertise to excel in supporting manufacturing processes.
Drive the team’s success in complex task management and enhance routine operational efficiency
Manage resource-plan and schedule of work for technology transfer and Manufacturing support.
Act as the primary liaison with clients, delivering updates and resolving process-related issues, ensuring seamless manufacturing outcomes.
Oversee the creation and critical review of GMP production reports and documents, ensuring compliance with CMC requirements.
Lead the development and assessment of Manufacturing Batch Production Records for new processes.
Conduct thorough evaluations of processes and equipment, recommending advancements for improved efficiency and robustness.
Manage the transfer of new Purification processes from Product Development to Manufacturing, overseeing Process Validation Studies and Monitoring Programs.
Lead Risk Assessments and devise strategic Risk Mitigation plans, ensuring a safe and compliant manufacturing environment.
Assess and determine staffing needs to optimally support manufacturing demands, making strategic recommendations to align with production goals.
Build a collaborative network, influencing cross-functional teams effectively, even without direct authority.
Engage actively in departmental and company-wide initiatives, contributing to overarching goals through teamwork and leadership.
Maintain and update knowledge of technologies integral to downstream manufacturing operations.
Undertake and successfully execute additional projects and assignments to refine and improve manufacturing systems.
Perform other duties as assigned.