Curve Biosciences™ is creating AI-driven insights into biology for the approximately 130 million patients living with chronic disease.
We've created the first molecular blueprint of the human body by manually curating the world's largest collection of comprehensively characterized tissue samples into our Whole-Body Atlas. Our Whole Body Intelligence platform uniquely positions us to deliver precise biological insights that complement existing clinical tools.
Led by a team with decades of biotechnology experience and multiple successful exits, our mission is to equip physicians with better tools to alleviate the burden of chronic disease by anchoring medicine in biological truth.
About the Role
We are seeking an exceptional, hands‑on Process Engineering Manager to lead the development, optimization, and scale‑up of our molecular diagnostic laboratory processes.
This is a unique opportunity to build and own the Process Engineering function at a rapidly growing molecular diagnostics company. You will be responsible for translating complex biochemical assays from research and development into robust, reproducible, efficient, and scalable clinical laboratory workflows.
The ideal candidate combines deep expertise in biochemistry and molecular assay development with strong process engineering fundamentals, analytical problem‑solving abilities, and a systems‑level understanding of laboratory operations.
You will work at the intersection of assay development, laboratory automation, software engineering, and clinical laboratory operations to ensure that our production processes meet demanding requirements for quality, reliability, throughput, and cost efficiency.
This is a highly hands‑on role. Initially, you will serve as an individual contributor while independently owning the Process Engineering function, including its technical roadmap, project prioritization, execution, and cross‑functional coordination. As the organization grows, you will be responsible for recruiting, mentoring, and managing a team of process engineers.
We are looking for someone who enjoys solving difficult technical problems, thrives in an early‑stage environment, and is excited to build both the processes and the organization required to support a production‑scale molecular diagnostics laboratory.
Key Responsibilities
Assay Industrialization & Process Development
- Lead the transfer of molecular assays from R&D into robust, reproducible, and scalable clinical laboratory workflows.
- Design, develop, characterize, and optimize laboratory processes with an emphasis on assay performance, reproducibility, throughput, operational simplicity, and cost efficiency.
- Apply principles of experimental design, statistical analysis, and process characterization to identify critical process parameters, understand sources of variability, and establish stable operating ranges.
- Partner with Assay Development, Automation Engineering, and Laboratory Operations to translate complex biochemical protocols into production‑ready processes.
- Independently troubleshoot complex biochemical and molecular assay failures in production, applying a deep understanding of underlying assay chemistry to identify root causes and implement sustainable solutions.
Reagent Manufacturing & Process Scale‑Up
- Design and optimize scalable processes for reagent preparation, formulation, batching, aliquoting, and quality control
- Establish robust manufacturing workflows that ensure reagent consistency, traceability, stability, and reliable assay performance
- Develop strategies to improve reagent manufacturing efficiency, reduce waste, and support increasing clinical testing volumes.
- Partner with relevant teams to support reagent inventory management, lot qualification, and supply continuity.
Laboratory Systems & Digital Workflow Design
- Own the operational design and functional requirements for laboratory workflows and supporting digital systems, including sample and plate tracking, sample and plate storage and retrieval, sample and reagent plate barcoding, and process monitoring
- Define laboratory key performance indicators and design analytical dashboards to monitor assay performance, process variability, throughput, failure rates, and operational efficiency.
- Translate laboratory requirements into clear, actionable development requests and collaborate with relevant teams (Software Engineering, Automation Engineering, R&D) to implement and validate solutions.
- Use data analysis and statistical methods to identify process trends, detect performance drift, and prioritize continuous improvement opportunities.
Process Validation, Quality & Documentation
- Develop and maintain process documentation, standard operating procedures, work instructions, and technical specifications.
- Support analytical validation, process verification, and technology transfer activities associated with clinical laboratory readiness and ongoing operations.
- Establish appropriate process controls, monitoring strategies, and acceptance criteria to ensure consistent performance.
- Collaborate with Laboratory Operations and Quality to ensure processes are implemented and maintained in accordance with applicable CLIA requirements and internal quality standards.
Required Qualifications
- Bachelor’s or advanced degree in Biochemistry, Molecular Biology, Chemical Engineering, Bioengineering, Biotechnology, or related field.
- 7+ years of relevant industry experience in molecular diagnostics or related laboratory-intensive environments.
- Demonstrated experience developing, optimizing, troubleshooting, and scaling complex molecular biology assays.
- Strong working knowledge of biochemistry and molecular assay principles, with the ability to independently investigate complex assay failures and identify underlying causes.
- Hands‑on experience with translating research-stage laboratory protocols into robust, reproducible production workflows.
- Demonstrated ability to independently lead complex technical projects, coordinate cross‑functional stakeholders, and drive initiatives through to completion.
- Excellent written and verbal communication skills, including the ability to translate complex technical problems into clear requirements, recommendations, and action plans
- Willingness and enthusiasm to work hands‑on in the laboratory while assuming broad ownership of a growing engineering function.
- A low‑ego, collaborative engineering mindset, with a willingness to give and receive candid technical feedback and align around shared decisions.
Preferred Qualifications
- Experience developing or scaling nucleic acid extraction, next‑generation sequencing, PCR or other high complexity molecular diagnostic workflows.
- Experience working in a CLIA‑regulated clinical laboratory or other quality‑controlled diagnostic production environment.
- Familiarity with laboratory automation platforms and liquid handling equipment.
- Experience designing laboratory sample tracking and reagent‑traceability workflows.
- Proficiency with Python, SQL, R, or similar programming tools for experimental data analysis and troubleshooting activities
- Experience applying statistical process control, design of experiments, or other structured process improvement methodologies.
- Experience with reagent manufacturing scale‑up, lot qualification, stability studies, and manufacturing process controls.
Work Location
This is a full‑time, onsite position based in San Mateo, California. The role requires regular hands‑on laboratory work and close in‑person collaboration with scientific, engineering, and laboratory operations teams.
Compensation
The anticipated annual base salary range for this position is $165,000–$180,000 excluding potential annual cash bonuses and equity compensation.
Final compensation will depend on the candidate's experience, qualifications, and scope of responsibilities.
Employee Benefits
Curve Biosciences is dedicated to improving patients' lives while supporting the professional and personal growth of our employees.
Our benefits include:
- Early‑stage equity participation
- Flexible paid time off
- Comprehensive medical, dental, and vision coverage
- 401(k) plan
- Professional development and mentorship from experienced biotechnology and technology leaders
- Modern, top‑floor laboratory and office facilities in San Mateo
- Daily lunches, snacks, and beverages
- On‑site gym
Equal Opportunity Employer
Curve Biosciences is an equal opportunity employer. We value diversity and are committed to providing equal employment opportunities without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, age, marital status, veteran status, disability, or any other status protected by applicable law.