Sr. Scientist

About Akoya Biosciences, Inc.

As The Spatial Biology Company®, Akoya Biosciences’ mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow researchers to phenotype cells with spatial context and visualize how they organize and interact to influence disease progression and response to therapy. Akoya offers a full continuum of spatial phenotyping solutions to serve the diverse needs of researchers across discovery, translational and clinical research: PhenoCode™ Panels and PhenoCycler®, PhenoImager® Fusion, and PhenoImager HT Instruments.

Job Description Summary

Akoya is seeking a Senior Scientist at their Marlborough MA location (onsite) who will have direct responsibility for the technical assessment and development of In-Vitro Diagnostic (IVD) and Companion assays (CDx) using our PhenoImager HT platform, the industry standard for multiplex immunofluorescence (mIF), for precise and efficient cancer screening and diagnosis.

The Senior Scientist will have a solid understanding of using immunohistochemistry (IHC) to assess tissue biomarkers for CDx diagnostic products. A track record of IHC/IF assay development and validation in a GCLP or related regulated product development environment is necessary.

Requirements for the role include detailed understanding of the evaluation of IHC assays and assay controls through feasibility, development/optimization, verification and validation (V&V), as well as design transfer for manufacturing in compliance with quality system requirements. Candidates must have experience in producing design and development documentation for CDx products under design controls.

Incumbent will have a “building the right product, right” mentality, leveraging strong analytical and problem-solving skills, who can communicate cross-functionally and/or directly address needs, problems, or issues as they arise, e.g., technical, regulatory, business, and operational.

Responsibilities may grow to include leading a small team with expertise in histology, IHC and mIF techniques, and greater accountability for workflow strategies (study design, project documentation, data generation, conclusions) to support Akoya’s IVD pipeline.

Duties and Responsibilities

• Apply technical expertise in IHC/mIF to support efforts in system design, implementation, integration, test method development and V&V of medical devices and diagnostic products.
• Independently designs and executes experiments.
• Creates product documentation under design control including V&V plans, protocols, and reports in support of CDx product regulatory submissions.
• Supports CDx development activities as an assay subject matter expert including risk assessments and requirements generation/management.
• Produces product design documentation including assay and reagent specifications for inclusion in the product design history file.
• Presents technical findings to both internal and external stakeholders.
• Leads the assay development content creation and presentation for formal design reviews.
• Participates or leads in efforts to define new components, products, or processes.
• Apply working knowledge of design of experiment (DOE) for analysis and interpretation of test results, including risk assessments, failure investigation and root cause analysis.

• Communicate with project team members (Core Team and extended), functional managers, senior leaders, stakeholders, and partners.
• Collaborate with Core Team members and functional area leads (including product management, program management, clinical, quality assurance, regulatory affairs, assay development, software development, and operations) to ensure alignment with the overall product development strategy.

• Support generation of appropriate Standard Operating Procedures (SOPs) for laboratory equipment and ensure proper usage of record keeping (LIMS and ELN) systems for all activities performed in the laboratory.
• Comply with Akoya’s Quality Management System policies, industry standards and national & international regulations (e.g., ISO, FDA QSR).
Other duties as assigned

Qualifications/Skills

• Requires a PhD with 3+ years of experience in a Life Sciences related area in an academic or bio/pharma environment. Candidates may be considered with a BS and 8-10 years of relevant experience, or a MS and 5-10 years of relevant experience depending on work history.
• Experience with IHC/IF staining and imaging, if possible, with the Phenoptics workflow.
• Direct experience in a histopathology laboratory focusing on clinical IHC workflows, for professionals with commercial laboratory experience, diagnostics and/or biopharma experience, or having roles within a medical device or IVD company developing diagnostic tests, reagent kits or diagnostic systems.

• Understanding of ISO 13485:2016 standard and Code of Federal Regulations (CFR) 21§820.30 Design Controls and knowledge of, or previous experience of, developing products under design control as well as risk management standards (e.g., ISO 14971).
• Excellent oral, written and presentation-based communication and influencing skills, able to prioritize and manage multiple concurrent projects and drive to results with a high emphasis on quality.
• Able to maintain open communication with internal employees, managers, and external customers as needed, to integrate and apply feedback in a professional manner.

The hiring range for this position is $125,000 - $165,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Akoya’s excellent benefits program includes a selection of Medical and Dental plans, and Life, AD&D and Short-Term Disability insurance, Tuition Reimbursement, 401(k) with immediate Company match vesting, Company paid holidays and more!

Akoya values bringing together individuals with diverse backgrounds. We are proud to be an Equal Opportunity/Affirmative Action Employer. We do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.