Lead Manufacturing Associate, Downstream

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:

Step into a leadership role as a Lead Manufacturing Associate, Downstream. where you'll spearhead operations in our cutting-edge viral vector facility. This position goes beyond the typical manufacturing role; it's about leading in the absence of the area manager, setting the standard for excellence, and guiding a team towards the successful production of vital gene therapies. With your deep understanding of GMP and hands-on experience with virus production, you'll not only play a critical role in the timely release of top-quality biopharmaceuticals but also nurture a team's development and operational success. Join us and be a part of a mission-driven team committed to enhancing patient lives through innovation, integrity, and teamwork, all while advancing your career in a dynamic and supportive environment.

• Maintain individual training plan and ensure the training profile remains up to date at all times in addition to train and mentor junior manufacturing associates.

• Lead the department in the absence of the area manager. Clearly communicate problem, challenges and observations with manufacturing management and management from other departments.

• Lead the operations and act as a main point of contact within the cleanroom.

• Ensure the timely setup of equipment and materials for each production run.

• Plan and prepare all necessary resources for various processes and activities.

• Responsible for setting the priority of manufacturing schedule and executing the daily manufacturing plan communicated by the Manufacturing Management.

• Possess advanced operational skills, troubleshooting skills and process an advanced knowledge within an aseptic environment, biological safety cabinet, isolator and to execute various processes including but not limited to Harvest, Clarification, Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.

• Conduct analytical tests such as osmolality, pH, conductivity, and filter integrity testing.

• Assist in other production areas as needed and Support discrepancies root cause investigation and CAPA implementation.

• Demonstrate exceptional aseptic techniques with precise, deliberate movements.

• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company.

• Ensure cleanrooms are cleaned, organized, maintained and audit ready at all times. Maintain department inventory and ensure all materials are kitted for next operations.

• Adherence to cGMPs (and/or ISO standards) is always required during the manufacture of Bulk Drug products, Final Drug substances and research/development products. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Demonstrate initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.

• Lead independent projects as assigned, contributing to the overall success of the manufacturing team.

• Prepare media and buffer solutions critical for production processes.

• Perform other duties as assigned.

Minimum Qualifications:

• Bachelor of Science degree in a relevant field, such as biochemistry or biology.

• 4+ years of experience in GMP manufacturing of biologics.

• 1+ years of leadership experience with ability to motivate and develop a high performing team.

• Proven logic and decision-making abilities and 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.

• Excellent problem-solving skills and attention to detail.

• Effective communication and interpersonal skills with the ability to collaborate cross functional teams.

• Flexibility to adapt to changing priorities.

• Commitment to quality, safety, and compliance in all aspects of Manufacturing operations.

Preferred Qualifications:

• 1+ years of virus production experience.

• Previous downstream experience is essential.

• Previous upstream experience is preferred.

Position Type/Expected Hours of Work:

This role is a full-time position operating Monday through Friday. The employee must also, if instructed, be able to work overtime and/or weekends when needed.

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 $31.77-$42.35 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 (include range) 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.