Senior Scientist, IVD Assay Development
- Employer
- Akoya Biosciences
- Location
- Marlborough, MA
- Closing date
- Oct 4, 2022
You need to sign in or create an account to save a job.
Job DescriptionSalary:
About Akoya Biosciences: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 via its key platforms: PhenoCycler™, PhenoImager™ Fusion and PhenoImager HT.
Position 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 the use for immunohistochemistry (IHC) to assess tissue biomarkers in biomarker-driven clinical trials. A track record of IHC/IF assay development and validation in a GCLP or related regulated 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) procedures, as well as design transfer for manufacturing in compliance with quality system requirements.
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 & Responsibilities:
Skills & Requirements:
Akoya Biosciences, Inc. proudly affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.
About Akoya Biosciences: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 via its key platforms: PhenoCycler™, PhenoImager™ Fusion and PhenoImager HT.
Position 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 the use for immunohistochemistry (IHC) to assess tissue biomarkers in biomarker-driven clinical trials. A track record of IHC/IF assay development and validation in a GCLP or related regulated 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) procedures, as well as design transfer for manufacturing in compliance with quality system requirements.
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 & 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 products.
- Independently designs and executes experiments.
- 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).
Skills & Requirements:
- Requires a PhD with 3-5 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 experience, or a MS and 5-10 years of experience depending on work history.
- Preference for 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.
- Experience with IHC/IF staining and imaging, if possible, with the Phenoptics workflow.
- 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.
Akoya Biosciences, Inc. proudly affords equal employment opportunity to all qualified persons regardless of race, color, religious creed, national origin, age, military status, sexual orientation, disability, genetic information, gender identity, gender expression or gender unless based upon a bona fide occupational qualification.
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert