Process Scientist II

Position Overview

The Process Scientist II collaborates on a variety of clinical projects associated with some or all of the following areas: study design, assay development, manufacturing, quality or various clinical laboratory projects. They work closely with CLDs, QA, and RA to assess risk to products upon validation of new processes and optimization of current processes. The Process Scientist II utilizes their expertise to identify, lead, and manage process improvements in the clinical laboratory. Working knowledge of clinical regulations (FDA, CLIA/CAP, and NYS CLEP), validation experience, and technical writing is required for this role.

Author and/or review written laboratory protocols, standard operating procedures, and LIMS workflows.  Provide technical functions and support for FDA and CLIA/CAP regulated high complexity clinical laboratory performing molecular testing using NGS. Assist with maintenance of laboratory compliance.

This position is associated with the Molecular Laboratory Scaling and Sustaining team and is responsible for leading projects related to operational improvements and product/instrument upgrades for our regulated laboratory.

Key Responsibilities and Essential Functions

• Lead high complexity and cross-functional laboratory scaling, validation, and process improvement projects.
• Collaborate regularly across teams and within the ML S&S team to design, develop, and execute: Performance Qualifications, Comparability studies, End-to-End Testing, and Method Validations.
• Participate in assay validations, comparability studies, and process improvement projects using in-house data management software (LIMS), with minimal instruction on new assignments.
• Timely completion of documentation and online entries into document control
• Adhere to CLIA/CAP/GCP systems and processes in the laboratory; maintain a high quality and accuracy of work.
• Provide support and recommendations for FDA-level analytical method development and method validations.
• Maintain the operational status of equipment in support of laboratory processes, including troubleshooting.
• Promote a culture of professionalism where every patient result matters and alignment with company goals and values.
• All other duties as assigned

Position Requirements (Education, Experience, Other)

Required

• Earned a Ph.D, MS, or BS degree in a Biological Chemical, or Physical science from an accredited institution, and at least 2, 4, or 6 years, respectively, of laboratory training or experience in high complexity clinical testing under the direct or indirect supervision of a board-certified clinical laboratory director.
• At least two years of cross-functional validation and/or regulatory experience in a high complexity clinical laboratory.

PLUS

• Specialized knowledge, experience and skills: Molecular biology techniques (DNA extraction, PCR, Next-generation sequencing [NGS]), laboratory automation, Laboratory information management systems, reagent and instrument qualification, NGS data analysis, CAP/CLIA regulations.
• Understanding of laboratory regulations and clinical validation requirements (CLIA/CAP, CLEP, FDA).
• Strong interpersonal and communication skills (both written and spoken), ability to collaborate across teams and disciplines.

Preferred

• Advanced critical thinking and problem-solving skills and results-oriented balancing initiative
• Six Sigma experience
• Strong analytical and planning skills with keen attention to details and deadlines.
• Ability to work in a team environment
• Promotes a positive work environment while supporting management and business goals
• Ability to collaborate across teams and disciplines
• Creates a productive and professional culture
• Upholds clinical laboratory best practices and complies with applicable regulations

Working Conditions

There will be occasional work in a laboratory handling human biological specimens, flexibility and willingness to work more than standard hours when necessary, including nights & weekends

Physical Requirements

Prolonged periods of working at a computer. May include some time shadowing laboratory staff or working in the laboratory.

Compensation

Salary Range: $90,000 - $135,000

Other compensation elements include:

• equity grant
• bonus eligible