Sr. Manufacturing Associate, Downstream (Early Phase)

Avid Bioservices; Costa Mesa (CA); On-site; USD 66,000 - 88,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices in Costa Mesa, CA seeks a Sr. Manufacturing Associate - Downstream to lead virus purification and filtration in a state-of-the-art facility.

You will work under GMP standards, perform analytical tests, and help ensure timely production of biologics with a focus on aseptic techniques and accurate documentation. The role requires 2+ years in GMP biologics downstream, a BS degree, and a readiness to mentor junior staff while complying with regulatory standards.

Qualifications

• BS in Biotechnology, Biology, Chemistry or equivalent, preferred biochemistry/biology focus.
• 2+ years of GMP biologics downstream experience.
• Aseptic practices and clean room operations.
• Knowledge of GMP, FDA and EMA requirements for biologics.
• Familiarity with downstream processes and latest technologies.

Responsibilities

• Prioritize and execute daily manufacturing schedules for downstream operations.
• Troubleshoot equipment and processes in collaboration with MS&T.
• Conduct osmolality, pH, conductivity and filter integrity tests.
• Train junior manufacturing associates.
• Ensure setup and readiness of equipment for production runs.
• Maintain cleanrooms, inventory, and GMP documentation.

Skills

GMP manufacturing

Aseptic techniques

Process troubleshooting

Analytical testing

Strong communication

Education

Bachelor's degree in Biotechnology or related

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 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:

• 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 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.

Preferred Qualifications:

• 1+ years of virus production experience is preferred.
• Previous upstream experience is a plus.

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, equity grants, 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 depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

we understand the importance of attracting and retaining top talent. The expected base pay range for this position is ($66,100-$88,100) plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being.

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.