Principal Scientist, Lyophilization Development

Position Summary

We are seeking a highly motivated and accomplished Principal Scientist to join our Product Development team. This individual will serve as a senior technical leader responsible for the development, optimization, and transfer of lyophilization processes from R&D into manufacturing. The ideal candidate will bring deep technical expertise in all aspects of lyophilization and freeze-drying including development, QC, and process transfer. This role requires the ability to operate with significant autonomy, influence technical direction across programs, and mentor scientists while driving high-impact outcomes for the organization. 

Duties and Responsibilities

• Provide technical leadership across multiple product development programs, influencing strategy, experimental design, and execution. 
• Drive product and process transfer from R&D to Manufacturing, including the development of robust, scalable, and cost-effective lyophilization based production processes. 
• Design and execute experiments to characterize product performance, stability, manufacturability, and lifecycle robustness. 
• Technical owner of lyophilization equipment including lyophilizers, DSC, and cryo-microscopy instruments. 
• Define, develop, and validate QC methods, specifications, and control strategies to ensure product quality and consistency. 
• Author, review, and approve technical documentation including SOPs, batch records, product specifications, validation reports, and technology transfer packages. 
• Collaborate closely with R&D, Manufacturing, Quality, Operations, and external partners to support design transfer, risk assessments, and process validations. 
• Lead complex troubleshooting efforts, root cause investigations, and continuous improvement initiatives for product or process deviations. 
• Mentor junior scientists, contributing to scientific rigor, capability building, and succession planning. 

Qualifications

• Ph.D. in Biochemistry, Molecular Biology, Chemistry, Pharmaceutical Sciences, or a related field with 11+ years of relevant industry experience with progressively increasing responsibility. 
• Demonstrated technical authority in lyophilization and product and process transfer within a regulated and/or ISO-compliant environment. 
• Strong system level problem solving skills, including root cause analysis, DOE, statistical analysis, and process validation using JMP or similar tools. 
• Demonstrated ability to influence cross-functional teams and stakeholders. 
• Exceptional organizational, communication, and technical documentation skills with strong attention to detail. 
• Ability to thrive in a fast-paced, collaborative, and mission-driven environment. 

Preferred Qualifications 

• Expertise in running and optimizing immunoassays 
• Experience with automated liquid handling systems, high-throughput assays, and/or scaled manufacturing processes. 
• Data analysis capabilities using languages such as Python or R. 
• Knowledge of regulatory requirements for RUO and IVD products. 

The base salary range for this full-time position is $180,000 - $200,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.