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Description

ob Overview

At ARK Diagnostics, Inc., we develop high-performance immunoassays that enable clinicians to make critical treatment decisions. As we expand our manufacturing capabilities, we are seeking an Senior Bioprocess Engineer (IVD) to support the development, scale-up, and commercialization of our assay technologies.

In this role, you will work at the interface of R&D and Manufacturing, translating lab-scale products into robust, scalable production processes. You will collaborate with cross-functional teams to support new product introductions, optimize reagent manufacturing, and ensure processes meet the performance, quality, and regulatory standards required in clinical diagnostics.

This position is well suited for an engineer or scientist who enjoys solving complex process challenges and improving manufacturing performance in a regulated IVD environment.

Key responsibilities:

• Design and optimize manufacturing processes for IVD reagents, including antibodies, enzymes, and specialized assay components, ensuring robust performance and reproducibility.
• Lead scale-up activities, transferring lab-scale products into high-volume commercial production while maintaining analytical sensitivity, specificity, and quality standards.
• Support sustaining engineering efforts by troubleshooting process deviations, investigating non-conformances, and implementing continuous improvement and cost-reduction initiatives.
• Drive New Product Introduction (NPI), by partnering with R&D and Quality to transfer new and existing products and technologies into validated manufacturing environments.
• Author and execute validation protocols (IQ/OQ/PQ) for equipment and processes to ensure compliance with regulatory and clinical requirements.

Requirements

• Bachelor’s or Master’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related field.
• 5+ years of relevant industry experience; IVD or medical device sector preferred.
• Strong knowledge of IVD regulatory frameworks, including IVDD/IVDR, FDA QSR, and ISO 13485 standards.
• Hands-on experience with bioprocessing systems, diafiltration/ultrafiltration, and protein purification. Experience with Design of Experiments (DoE) methodologies preferred.
• Strong analytical, troubleshooting, and cross-functional collaboration skills in regulated manufacturing environments.
• Experience with or understanding of Six Sigma methodologies preferred.

Benefits

ARK anticipates that the annual base salary for the Senior Bioprocess Engineer could range between $128,000- $155,000. Compensation will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal position salary ranges, and market data. Annual base salary is just one piece of the total rewards program offered by ARK. Eligible roles come with a comprehensive benefits package and may also qualify for a variable annual bonus, contingent on company and/or individual performance in accordance with company policy.

Benefits

• 401(k) and 401(k) matching
• Health, dental, and vision insurance
• Health Savings Account (HSA) and Flexible Spending Account (FSA)
• Life insurance
• Paid time off
• Employee Assistance Program (EAP)
• Tuition reimbursement
• Referral program

Onsite Work Requirements

This position is fully onsite at our Fremont, CA facility.