Engineer, MSAT Upstream

Avid Bioservices; Tustin (CA); On-site; USD 95,000 - 119,000; Full time

Job summary

Avid Bioservices is seeking an Engineer, MSAT Upstream to serve as the main client and internal liaison, ensuring successful transfer and execution of upstream processes in manufacturing. You will collaborate with clients on process status, troubleshoot floor issues, and drive improvements to efficiency and risk reduction.

The role requires 2+ years in biologic upstream manufacturing, strong cGMP knowledge, and hands-on cell culture experience.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline required.
• 2+ years of biologic upstream manufacturing experience.
• Strong understanding of cGMPs and ability to resolve deviations on the floor.
• Team player with potential to lead projects.
• Hands-on cell culture and aseptic technique experience.

Responsibilities

• Develop and maintain positive client and internal partnerships.
• Communicate process status with clients and troubleshoot on the floor.
• Lead process tech transfers, troubleshoot issues, and drive process improvements.
• Author Batch Production Records, technical reports, and validation protocols.
• Scale-up assessments to translate PD-scale to Manufacturing-scale and assess equipment fit.
• Monitor process health and perform risk assessments identifying gaps and improvements.
• Provide training to Upstream Operators and assist CAPA investigations.
• Investigate root causes and assess impact of process/material/equipment changes.

Skills

Biologic upstream manufacturing

cGMPs

Cell culture

Process transfer

Leadership

Team collaboration

Education

Bachelor’s degree in science/engineering

Master’s degree in science/engineering

Tools

DeltaV software

Upstream bioreactors 100L+

Wave technology

Centrifuge

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:

As an Engineer, MSAT Upstreamat Avid Bio, you will be the main point of contact for clients and internal departments, providing technical support and ensuring successful transfer and execution of new upstream processes in manufacturing. You will work closely with our clients to collaborate on upstream process status and troubleshoot issues on the floor. You will also play a critical role in driving process improvement to increase efficiency and decrease risk.

Key Responsibilities:

• Develop and cultivate positive client and internal Avid group partnerships.
• Communicate with clients on process status and collaborate to resolve issues on the floor.
• Provide technical expertise to lead process tech transfers, troubleshoot process issues, and implement process improvements.
• Author Manufacturing Batch Production Records, technical reports, and Process Validation Protocols.
• Perform proper scale-up assessments to translate executed PD-scale process into Manufacturing scale and perform proper equipment and facility fit assessment for new processes or process changes to ensure proper execution.
• Monitor process health through process monitoring and author technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.
• Provide technical training to Upstream Manufacturing Operators and assist in CAPA investigations and recommend dispositions.
• Conduct systematic investigations of root causes or problems or identified risks and evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.
• Other tasks as assigned.

Minimum Qualifications:

• Bachelor’s degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
• 2 + years of biologic upstream manufacturing experience.
• Strong understanding of cGMPs or equivalent standards and be able to make sound decisions to resolve or escalating deviations and/or issues on the production floor.
• A team player who can oversee a project from start to finish with little to no supervision.
• Track record of strong leadership.
• Hands-on experience with cell culture process and aseptic techniques.

Preferred Qualifications:

• Masters’ degree in a scientific or engineering discipline (chemical, mechanical, or biomedical).
• Hands-on experience with Upstream process equipment (is a plus) including, but not limited to:
  • Large scale single use bioreactors (100L and up)
  • Wave technology
  • Harvest technology (3M, Millistak, and/or centrifuge)
  • DeltaV software (preferred)

Position Type/Expected Hours of Work:

This role is a full-time position. Days of work are Monday through Friday. The employee must also, if instructed, have the ability to work 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 $95,200 - $119,000 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 25 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.