Manufacturing Associate Downstream

Posted 10 Days Ago
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Tustin, CA, USA
In-Office
22-27 Hourly
Junior
Healthtech • Pharmaceutical
Transforming the CDMO experience: Unrivaled expertise. Worldclass facilities. Exceptional quality. Personalized process.
The Role
Manufacturing Associate supporting downstream biopharmaceutical production in a GMP, aseptic cleanroom environment. Responsibilities include operating chromatography equipment, purifying antibodies and enzymes, filtration, buffer and media preparation, equipment setup and maintenance, batch documentation, inventory management, cleaning, calibration, and autoclave operation. The role also supports filling, media fills, SOP and batch record revisions, filter integrity testing, and independent manufacturing projects.
Summary Generated by Built In
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, apply now and be part of our journey!
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.  

Skills Required

  • 2+ years of related experience and/or training, or an equivalent combination of education and experience
  • Bachelor's or Associate degree, preferably with a 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 working in a GMP production environment with aseptic techniques
  • Ability to gown for a Class 10,000 cleanroom and work under aseptic conditions in a Class 100 environment
  • Ability to work full-time onsite, with overtime and weekends when necessary

Avid Bioservices Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Avid Bioservices and has not been reviewed or approved by Avid Bioservices.

  • Healthcare Strength Health coverage includes medical, dental, and vision alongside life and disability insurance. Plan breadth is presented as solid, with health benefits frequently highlighted as a strong element of the package.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discounted purchase feature and the availability of stock grants provide accessible ownership opportunities. These components add long-term value beyond base pay.
  • Fair & Transparent Compensation Pay ranges are posted for some roles, offering upfront clarity on expected compensation. This transparency supports clearer expectations during hiring.

Avid Bioservices Insights

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The Company
HQ: Tustin, California
343 Employees
Year Founded: 2002

What We Do

Avid Bioservices is transforming the CDMO experience, with more than 30 years of unrivaled experience manufacturing biologics, and world-class mammalian protein facilities. We’ve produced more than 250 commercial batches, and 5 commercial products marketed in 90+ countries. For more than 10 years, we’ve maintained a flawless quality track record which we’re committed to uphold. We do it right the first time, which saves money and time. From early-stage to late-stage, concept to market, every part of our process is personalized. We’re your advocates, your trusted experts, your true partners.

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