Manufacturing Associate Downstream

Avid Bioservices; Tustin (CA); On-site; USD 30,000 - 36,000; Full time

Job summary

Avid Bioservices in California is seeking a Manufacturing Associate, Downstream, to support multi-product production in a CGMP environment. You will be involved in production, documentation, materials procurement, and equipment scheduling to ensure timely release of high-quality biologics.

Role requires cleanroom gowning ability and experience with chromatography and GMP documentation. This full-time onsite position offers a collaborative team, growth opportunities, and a strong patient-impact

Qualifications

• 2+ years of related manufacturing experience in biopharma.
• Experience with large-scale liquid chromatography columns or similar equipment.
• GMP and aseptic technique proficiency.
• Ability to gown for cleanroom environments (class 10,000 to 100) and work aseptically.
• Strong documentation and batch-record skills.

Responsibilities

• Set up equipment and materials for production runs.
• Plan resources for various processes and activities.
• Operate and maintain chromatography skids.
• Handle packing, unpacking, and cleaning of production-scale chromatography columns.
• Perform antibody and enzyme purification using multiple chromatography methods.
• Calibrate pH and conductivity meters.
• Manage filtration processes including sterile and viral filtration.
• Maintain aseptic techniques during operations and fills.
• Keep cleanroom facilities and equipment in good condition.
• Document GMP-compliant records and batch production records.

Skills

Attention to detail

Team player

Communication

Multitasking

GMP awareness

Education

BSc Biology

AS Chemistry

Tools

Chromatography

Sartocheck

Autoclave

Job 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 related experience and/or training; or equivalent combination of education and experience.

Preferred Qualifications:

• Bachelor's or Associate degree (A.A.) with a preference for Biology or Chemistry emphasis.
• 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.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

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.