Position Summary:

The Principal Scientist supervises laboratory staff to support bioanalytical activities. Lead Bioanalysis and Biomarker projects through assay design and development, validation, and execution in a timely manner.  Perform assays according to SOPs and support technology development in Ligand Binding platform.

Essential functions of the job include but are not limited to:

• Design and perform experiments, independently and accurately analyze and present data
• Provide high quality output with the ability to build efficiency into improving productivity metrics
• Serve as Technical Lead in Ligand Binding Platform
• Assist in establishing and improving all procedures and required SOP documentation
• Responsible for assay trouble shooting and correcting routine scientific issues/problems
• Identify, update and implement emerging laboratory techniques
• Maintain and support lab safety practices and environment
• Work collaboratively with other technical teams in resource sharing and providing technical expertise
• Support new equipment operational qualifications and performance checks
• Monitor Lab Service/R&D related project expenses
• Act as a scientific resource externally to clients and internally
• Assists with writing, reviewing and editing contract and grant applications/proposals as appropriate
• Assist with writing and publishing papers, abstracts, techniques/or chapters to maintain the scientific standard and image of the company.
• May present completed work at appropriate scientific meetings and in publications
• Supervision of assigned laboratory staff to ensure efficient organization, development and execution of project(s)
• Other duties as assigned

Qualifications:

Minimum Required:

• Must have a Ph.D. in life sciences or relevant field in life sciences
• At least 8 years of full-time post-doctoral laboratory experience

Other Required:

• Strong background in various technology platforms such as Mesoscale Discovery, Quanterix, Luminex, ELISA.
• Ability to troubleshoot and refine bioanalysis and biomarkers assays such as ADA, PK, Potency Assay, Cytokine and PD biomarker measurement
• Experience in handling various sample matrix such as whole blood, plasma/serum, cell pellets/supernatant, urine and CSF
• Excellent communication, interpersonal, and organizational skills required.
• Must have the ability to organize and analyze data, as well as prepare technical reports.
• Must possess strong computational skills, preferably experienced with Softmax, MSD BenchWork, Word, Excel, Power Point, GraphPad Prism
• Excellent use of judgment and discretion required
• Extended work hours may be occasionally necessary in order to meet business demands
• Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
• Must be able to read, write, speak fluently and comprehend the English language

Preferred:

• A solid understanding of current bioanalytical method validation standards
• Experience supervising or mentoring scientists or technical personnel
• Previous work experience in GLP or GCLP or CLIA regulatory compliance

Job Summary:

The Senior Process Expert for PFM Labs will play a critical role in driving operational excellence across laboratory workflows. This role focuses on improving efficiency, standardization, quality, and cross functional alignment within PFM lab operations. The ideal candidate brings hands on laboratory experience (minimum 5+ years) and a strong understanding of end-to-end lab processes, enabling them to partner effectively with scientific, operational, and quality stakeholders.

Reporting directly to the VP of Business & Operational Excellence, the Process Expert will support the evaluation, design, implementation, and continuous improvement of lab workflows, ensuring seamless execution, clear responsibilities, and consistent delivery to internal and external partners.

Main Duties & Responsibilities:

Process Mapping & Optimization

• Map current and future‑state laboratory processes, including roles, handoffs, and decision points.
• Participate in root-cause problem-solving techniques with stakeholders to identify core process challenges.
• Identify bottlenecks, inefficiencies, and pain points in lab workflows (aligned with ongoing PFM BOE initiatives in labs).
• Propose and implement process improvements that enhance efficiency, turnaround times, and overall performance.
• Support development and maintenance of process narratives, RACIs, SOP linkages, and training materials.

Operational Excellence & Governance

• Partner with lab managers, scientists, QA, and cross‑functional SMEs to drive consistent execution across labs.
• Support organizational design discussions where processes intersect with roles and responsibilities.
• Participate in lab maturity assessments and optimization projects.

Change Management & Stakeholder Engagement

• Facilitate adoption of new or revised processes by preparing communication materials, training, and documentation.
• Support teams during transitions, ensuring clarity and accountability.
• Work collaboratively with process owners and SMEs to embed a “Precision Way” of running lab operations.

Performance Monitoring

• Assist in designing or refining process‑related KPIs and operational dashboards.
• Monitor performance against key metrics and identify areas for further improvement.
• Identify operational risks and develop mitigation plans.
• Enable data-driven decision making.

Minimum Education & Experience: 

• A bachelor’s degree in a related field, and 5+ years of hands-on laboratory experience in a clinical, central, research, specialty, or biomarker driven lab environment.
• Strong understanding of end-to-end sample lifecycle processes, from receipt and accessioning to analysis and reporting.
• Experience in process mapping, workflow analysis, or operational improvement.
• Six Sigma certifications preferred
• Familiarity with regulated lab environments (e.g., GxP, CAP/CLIA, ISO) preferred.
• Familiarity with continuous improvement tools eg. SIPOC, value stream mapping, dynamic workflow redesign

Preferred Education & Experience (optional):

• Background in Operational Excellence, Lean/Six Sigma, or continuous improvement.
• Experience contributing to the development of SOPs, work instructions, or training content.
• Demonstrated ability to manage multiple priorities and drive initiatives to completion.