Supervisor, Manufacturing Downstream

Avid Bioservices • Tustin, CA

2d • $75,000 - $95,000

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: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation. Schedule, plan and coordinate production activities. Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required. cGMP documentation. Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs). Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance. Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies. Coordinate manufacturing, validation, and maintenance activities with supporting departments. Oversee the setup of new manufacturing processes and critical equipment. Identify the technical, procedural and equipment issues that hinder production and compliance. Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems. Assist in the transfer of technology from Process Development to GMP Manufacturing. Assist with technical and compliance investigations, inspections and audits. Report all unsafe activities to department manager, EHS and/or Human Resources. Participate in proactive team efforts to achieve departmental and company goals. Manage direct reports and escalate issues to manager as needed. Perform other duties as assigned

Requirements

• Bachelor’s degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years’ cGMP purification experience or equivalent combination of experience and education
• A minimum of 3 years of supervisory experience specifically in downstream processing is required
• The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations
• 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.

Nice To Haves

• Bachelor's degree in life sciences or related field

Responsibilities

• Supervision of Downstream manufacturing staff and operations
• Hands-on operational activities
• Ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation
• Schedule, plan and coordinate production activities
• Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required
• cGMP documentation
• Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs)
• Identify, escalate, and write deviation reports (IRs/DRs/CAPAs)
• Follow through on corrective and preventative actions to ensure cGMP compliance
• Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies
• Coordinate manufacturing, validation, and maintenance activities with supporting departments
• Oversee the setup of new manufacturing processes and critical equipment
• Identify the technical, procedural and equipment issues that hinder production and compliance
• Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems
• Assist in the transfer of technology from Process Development to GMP Manufacturing
• Assist with technical and compliance investigations, inspections and audits
• Report all unsafe activities to department manager, EHS and/or Human Resources
• Participate in proactive team efforts to achieve departmental and company goals
• Manage direct reports and escalate issues to manager as needed
• Perform other duties as assigned

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees