Manufacturing Associate Support and Formulation

Avid Bioservices•Tustin, CA

4d•$23 - $27

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 Manufacturing Associate Support provides support for: Production Operations and multiple aspects of cGMP contract cell culture manufacturing in strict compliance with cGMP, under Standard Operating Procedures in a multi-product manufacturing facility, including, but not limited to production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products. The Manufacturing Associate will conduct themselves in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients’ lives by consistently delivering high-quality biopharmaceutical products.

Requirements

1+ years' experience in the life sciences industry experience.
Experience working in a GMP production environment with aseptic technique.

Nice To Haves

Bachelor’s or associate degree (A.A.) degree with an emphasis in biology or chemistry highly preferred.

Responsibilities

Maintains operational areas by ensuring that manufacturing clean rooms are neat and orderly in accordance with cGMPs.
Follows Good Manufacturing Practices and maintains a current GMP document-training log.
Ensures that equipment used in the GMP facility are in working order and are properly maintained.
Makes sure that there is a minimum inventory level of standard stock materials including gowning supplies.
Formulates buffers and media in accordance to established procedures for use in GMP operations.
Manually cleans small parts and equipment, performs daily monitoring of equipment and aseptic technique, and prepares glassware and equipment for production.
Filters integrity testing utilizing Sartocheck 3 Filter Integrity Tester.
Operates and maintains Autoclave (19 cu ft), Gruenberg Oven (15 cu ft), and Cozzoli vial washer.
Revises batch production records, SOP’s, and forms.
Measures raw materials, pH reading/adjustment, sampling, and filtering of buffer and media formulations for the Upstream team.
Works in conjunction with the Process Development team to assist in the transferring of technology to perform buffer and media formulations in a GMP setting.
Assists Manufacturing Associates with production processes.
Complies with all safety policies, practices and procedures and reports all unsafe activities to supervisor and/or Human Resources.
Participates in proactive team efforts to achieve departmental and company goals.
Trains new technicians on required processes and procedures as necessary.
Supports operation and maintenance of cell culture bioreactors (100L – 2000L stainless steel and disposable STR/SUB) in batch, fed-batch, and perfusion modes.
Performs equipment cleaning and sterilization – manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP).
Supports cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC).
Assists with operating and maintaining equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid.
Supports Harvest operations - pod filtration and TFF system.
Other tasks may be assigned as needed.