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Transforming the CDMO experience: Unrivaled expertise. Worldclass facilities. Exceptional quality. Personalized process.
The Role
Executes downstream biologics manufacturing activities, including viral vector harvest, clarification, TFF, chromatography, filtration, filling, buffer preparation, and analytical testing. Troubleshoots equipment and processes, maintains cleanrooms and inventories, ensures GMP-compliant documentation, supports production scheduling, and contributes to continuous improvement. Trains junior associates, prepares manufacturing records and procedures, communicates deviations and quality issues, and maintains aseptic practices and audit readiness.
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:
Your Role:
Join our team as a Sr. Manufacturing Associate - Downstream and be at the forefront of biopharmaceutical innovation. In this pivotal role, you'll drive the production of life-changing therapies in our state-of-the-art viral vector facility, utilizing your expertise in GMP and biologics manufacturing. With a focus on executing complex virus purification and filtration, you'll not only ensure the delivery of high-quality products but also mentor the next generation of scientists. Embrace this opportunity to grow your career, make a tangible impact on patients' lives, and contribute to a culture of Integrity, Adaptability, Innovation, Teamwork, and Passion. Your dedication and expertise will be the cornerstone of our success as we continue to revolutionize patient care.
Key Responsibilities:
Key Responsibilities:
- Support in prioritizing manufacturing schedule requirements and responsible for executing the daily manufacturing schedule within a fast-paced manufacturing operation with primary activities of virus purification techniques virus purification techniques virus purification techniques virus purification techniques including but not limited to Harvest, Clarification, Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.
- Troubleshoot equipment and processes in partnership with Manufacturing Science and Technology department.
- Conduct analytical tests such as osmolality, pH and conductivity in addition to filter integrity testing.
- Clearly communicate problems and observations with management from manufacturing and other departments.
- Possess the ability to train junior level manufacturing associates.
- Ensure the timely setup of equipment and materials for each production run.
- Plan and prepare all necessary resources for various processes and activities.
- Assist in other production areas as needed.
- Demonstrate exceptional aseptic techniques with precise, deliberate movements.
- Ensure cleanrooms are cleaned, organized, maintained and audit ready at all times. Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.
- Plan, organize and maintain material inventory for manufacturing processes.
- Comply with Good Manufacturing Practices (GMP) documentation standards.
- Demonstrate initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.
- Attend meetings, participate in continuous improvement projects. Demonstrate strong technical writing abilities (Deviation initiations, Sops, Logbooks, Working Instructions, Forms creation, etc.).
- Prepare media and buffer solutions critical for production processes.
- Adhere to cGMPs (and/or ISO standards) is always required during the manufacture of Bulk Drug products, Final Drug substances and research products. Own the quality of what they deliver and is responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Minimum Qualifications:
- BS in Biotechnology, Biology, Chemistry, or equivalent preferred. Preferred area of study: biochemistry or biology.
- 2+ years of experience in GMP manufacturing of biologics, previous experience in downstream process is essential.
- Proven logic and decision-making abilities, critical thinking skills. Aseptic practices and clean room operations:
- Advanced knowledge of GMP, FDA and EMA regulatory requirements applicable to Biologics including Gene/Viral therapy products focusing on Downstream Operations.
- Advanced knowledge of the manufacturing process and possesses the understanding of or ability to use the latest technologies.
Position Type/Expected Hours of Work:
This role is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m. unless otherwise stated by Supervisor. Must have the ability to be flexible working overtime, weekends and/or holidays when necessary.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $23.46 - $29.32 hourly annually 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
- Bachelor’s degree in Biotechnology, Biology, Chemistry, Biochemistry, or an equivalent field
- At least 2 years of GMP manufacturing experience in biologics
- Previous downstream processing experience
- Advanced knowledge of GMP, FDA, and EMA regulatory requirements applicable to biologics and gene or viral therapy products
- Knowledge of aseptic practices and cleanroom operations
- Advanced knowledge of biologics manufacturing processes and the ability to use current manufacturing technologies
- Logic, decision-making, and critical-thinking abilities
- Strong written and verbal communication skills
- Ability to train junior manufacturing associates
- Ability to work overtime, weekends, and holidays 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.
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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.
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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.
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Fair & Transparent Compensation — Pay ranges are posted for some roles, offering upfront clarity on expected compensation. This transparency supports clearer expectations during hiring.
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The Company
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.
