Supervisor, Manufacturing Downstream (M-F)
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.
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.
Nice To Haves
- Bachelor's degree in life sciences or related field.
- 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
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
