Sr. Manufacturing Associate, Downstream (Early Phase)

Avid Bioservices•Costa Mesa, CA

3d•Onsite

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. 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.

Requirements

BS in Biotechnology, Biology, Chemistry, or equivalent.
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.
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.

Nice To Haves

Preferred area of study: biochemistry or biology.
1+ years of virus production experience is preferred.
Previous upstream experience is a plus.

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 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.