Sr. Supervisor, Manufacturing Formulation

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. The Sr. Supervisor, Manufacturing Formulation is responsible for the supervision of 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

Related Bachelor’s degree (i.e. Biology, Biotechnology, Chemical Engineering) plus 3 - 5 years cGMP support and formulation experience plus 1 - 3 years leadership experience or equivalent combination of experience.
Exceptional multitasking skills and an unparalleled attention to detail.
Mastery 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.

Nice To Haves

A "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Written and verbal skills are out of this world, and you communicate with clarity and confidence.

Responsibilities

Schedule, plan and coordinate production activities.
Operate and maintain Manufacturing production support equipment including but not limited to autoclave, depyrogenation oven, Cozzolli vial/bottle washer, Sartocheck filter integrity testers, pH/conductivity meters, Laminar Flow Hoods and Biosafety Cabinets.
Support cell culture and bioreactor operations from thaw through TFF 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.
Performing daily monitoring of equipment and equipment cleaning – manual cleaning.
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.
Directs activities of functional areas through associate level employees.
Perform other duties as assigned.