Manufacturing Associate Downstream (Flex)

Avid Bioservices, Inc.; Tustin (CA); On-site; USD 30,000 - 37,000; Full time

Job summary

Avid Bioservices, a leading biopharmaceutical CDMO in California, is hiring a Manufacturing Associate, Downstream. You will support multi-product manufacture, operate chromatography skids, and ensure strict aseptic, GMP-compliant procedures in a fast-paced cleanroom environment.

This full-time onsite role runs Monday–Friday with evening hours and provides competitive benefits and career growth within our integrated bioprocessing facility.

Qualifications

• 2+ years of experience with large-scale liquid chromatography columns or similar equipment.
• 1+ years of related experience in the life sciences industry.
• GMP production environment experience with aseptic techniques.
• Ability to gown for a class 10,000 cleanroom environment and work aseptically in a class 100 environment.

Responsibilities

• Ensuring the timely setup of equipment and materials for each production run.
• Planning and preparing all necessary resources for various processes and activities.
• Operating and diligently maintaining BioProcess chromatography skids.
• Proficiently handling packing/unpacking and cleaning of production-scale chromatography columns.
• Executing antibody and enzyme purification techniques using multiple chromatography methods.
• Conducting pH and conductivity meter calibration and testing.
• Managing product filtration processes, including sterile filtration and ultrafiltration.
• Demonstrating aseptic techniques with precise movements.
• Participating in product filling, including aseptic processing and media fill qualifications.
• Upholding cleanliness and maintenance of cleanroom facilities and equipment.
• Monitoring and controlling raw material inventory levels.
• Ensuring GMP documentation standards are followed.
• Revising and initiating Batch Production Records, SOPs, study protocols, and reports.
• Leading and managing independent projects as assigned.

Skills

Aseptic techniques

GMP experience

Documentation

Attention to detail

Education

Bachelor’s or associate degree in biology or chemistry

Tools

Large-scale chromatography

Job description

Description

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

Join our dynamic team as a Manufacturing Associate, Downstream! In this role, you’ll be a crucial part of our multi-product manufacturing facility, working in strict compliance with cGMP and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous documentation, report writing, materials procurement, and equipment scheduling. You’ll be instrumental in ensuring the timely production and release of top-quality products. At our company, we value core principles such as Integrity, Adaptability, Innovation, Teamwork, and Passion, all united by a shared mission to enhance patients’ lives through the consistent delivery of high-quality biopharmaceuticals. If you’re ready to make a meaningful impact.

Key Responsibilities

• Ensuring the timely setup of equipment and materials for each production run.


• Planning and preparing all necessary resources for various processes and activities.


• Operating and diligently maintaining BioProcess chromatography skids.


• Proficiently handling the packing, unpacking, and cleaning of production-scale chromatography columns.


• Executing antibody and enzyme purification techniques using Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction, and Tangential Flow Filtration (TFF).


• Conducting pH and conductivity meter calibration and testing.


• Managing product filtration processes, including sterile filtration, ultrafiltration, and viral filtration.


• Demonstrating exceptional aseptic techniques with precise, deliberate movements.


• Participating in product filling, including aseptic processing and media fill qualifications.


• Upholding the cleanliness and maintenance of cleanroom facilities and equipment.


• Monitoring and controlling raw material inventory levels.


• Ensuring compliance with Good Manufacturing Practices (GMP) documentation standards.


• Taking the initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.


• Leading and managing independent projects as assigned, contributing to the overall success of the manufacturing team.


• Skillfully preparing media and buffer solutions critical for production processes.


• Conducting manual cleaning of small parts and equipment to maintain hygiene and efficiency.


• Performing thorough filter integrity testing using specialized equipment like the Sartocheck 3/4 Filter Integrity Tester.


• Operating and ensuring the proper maintenance of the ARS Frontier Autoclave.

Minimum Qualifications

• 2+ years of experience with large-scale liquid chromatography columns or similar equipment.


• 1+ years of related experience in the life sciences industry.


• Proficiency in working within a GMP production environment with aseptic techniques.


• Capability to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment.

Preferred Qualifications

• Bachelor’s or associate degree (A.A.) with a preference for biology or chemistry emphasis.

Position Type/Expected Hours of Work

This role is a full-time onsite position with a Monday through Friday schedule, working 5 days and 8 hours each day (5 days x 8 hours), with operating hours from 5:00pm to 2:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.

Compensation

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits as follows:

• health


• dental


• vision insurance


• 401(k) matching


• paid time off

The compensation range for this role is $21.53 - $26.92 hourly depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are

• 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.

Physical Demands & Work Environment

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.