Supervisor, Manufacturing Downstream

Avid Bioservices•Tustin, CA

7d•Onsite

About The Position

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. 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.
Exceptional multitasking skills and an unparalleled attention to detail.
Master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Visual acuity, including close, distance, and color vision, will be essential.

Nice To Haves

Bachelor's degree in life sciences or related field.

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.