Associate Engineer, Msat (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:

The Associate Engineer, MSAT (Downstream)'s primary responsibilities are to support the successful transfer and execution of new downstream processes into manufacturing. This requires an understanding of manufacturing downstream equipment and techniques to set up the manufacturing downstream operations for success. The Associate Engineer, MSAT (Downstream) should be capable of contributing to technical discussions on MSAT projects. The Associate Engineer, MSAT (Downstream) will drive process improvement to increase efficiency and decrease risk.

• Develop and cultivate positive client and internal Avid group (PD, MFG, QA, Validations, IT, Computerized Systems/Automation, etc.) partnerships.

• Capable of contributing to a project from start to finish with supervision in support of the MSAT technical Subject Matter Expert (SME).

• Ability to communicate with client on process status and collaborate to resolve issues on the floor.

• Provide technical expertise to support process tech transfers, troubleshoot process issues, and implement process improvements.

• Author Manufacturing Batch Production Records, Technical Reports, Standard Operating Procedures, User Requirement Specifications, Design Specifications, and Process Validation Protocols.

• Contribute to proper scale-up assessments to translate executed PD-scale process into manufacturing scale.

• Assist in proper equipment/facility fit and gap assessments for new processes or process changes to ensure proper execution.

• Author new product introduction protocols.

• Monitor process health through process monitoring.

• Assist in authoring technical risk assessments to identify gaps, incorporate new materials, and/or identify areas of improvement.

• Provide technical training to Manufacturing Downstream Operators.

• Assist in CAPA (Corrective Action Preventive Action) investigations and recommend dispositions. Conduct systematic investigations of root causes, problems, or identified risks.

• Research and identify new material and/or equipment for continuous improvement.

• Evaluate and assess the impacts of process, material, and equipment changes to product quality attributes.

• Prepare analysis and reports of proposed changes that are based on sound scientific and engineering principles.

• Ability to perform statistical analysis of data to form conclusions and recommendations.

• Performs other duties as assigned.

Minimum Qualifications:

• Bachelor's degree in scientific or engineering (chemical or biomedical) discipline

• Minimum of 1 year of downstream biologic manufacturing or process downstream development.

• Quality assurance knowledge.

• Hands-on experience with depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.

• Hands-on experience with downstream process equipment including, but not limited to AKTA ready column chromatography skids, large-scale filtration skids, Unicorn software.

• Track record for analyzing and resolving complex manufacturing and production issues using sound scientific principles.

• Batch production record, technical risk assessment, and/or technical protocol/study generation and review.

Preferred Qualifications:

• Master's degree in scientific or engineering (chemical or biomedical) discipline.

• Technical transfer, scale-up, and mass transfer of downstream processes.

• JMP statistical software.

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, holidays 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 $65,00-$87,700 annually 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 ($65,800-$87,700) 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.