Project Manager, New Products

Title: Project Manager, New Products (Marlborough, MA location)

About Akoya Biosciences, Inc.

Akoya Biosciences, Inc., The Spatial Biology Company™, with offices in Menlo Park, CA and
Marlborough, MA is a well-funded and emerging growth company that is developing powerful imaging tools to enable scientists and clinical researchers to gain a better understanding of complex diseases such as cancer and autoimmune disorders. Our CODEX® platform, spun out of the lab of Dr. Garry
Nolan at Stanford University, enables the assessment of more than 40 protein markers in a sample and is ideally suited for biomarker discovery. Our Phenoptics platform, the industry standard for multiplex
IF/IHC provides the assay robustness and throughput necessary for translational and clinical research required in clinical trials. Our partnerships with the academic community and our customers have resulted in a robust pipeline of future products.

Summary

Akoya Biosciences is looking for a Project Manager, New Products to join the Research & Development team. The individual will manage and lead product development projects across the Akoya Biosciences portfolio, with a special emphasis on reagent development and design transfer.

The Marlborough site recently built and is using a quality system and development process that is compliant with ISO-13485 and plans for ISO-13485 certification in mid-2020.

The role will partner with R&D, Quality, Operations, and Technical Support managers to drive new product development projects from product definition through design transfer and commercialization.

Key Responsibilities

 Holistically manage the design, development, and commercialization of new reagent, platform, and/or software products used in fluorescent multiplex tissue pathology.

 Leverage Akoya’s design and development process to lead multi-disciplinary, cross-functional teams to develop new products, with a focus on reagent development projects.

 Create and execute program plans with key program stakeholders that include timelines, resources, and budgets.

 Manage product design transfer to key contract manufacturing partners.
 Partner with Quality to ensure adherence to Akoya’s Quality System and identify and mitigate risks throughout the project lifecycle.
 Provide periodic updates to upper management on project status, risk, and risk management strategies.

1505 O’Brien Drive. Suite A1, Menlo Park, CA 94025 | 855.896.8401 | http://www.akoyabio.com | 100 Campus Drive, 6th Floor, Marlborough, MA 01752

Required

• 2-5 years of project/program management developing new products preferably related to the life sciences or medical device industries

• Bachelor’s degree or master’s degree in Science (Biology, Chemistry) or Engineering

(Biomedical) or related fields

Skills and Qualifications

 Excellent communication skills (enjoys working with diverse team members)
 Effectively manage experts from multiple technical disciplines
 Must be proficient in Microsoft Office (Microsoft Project a plus, but not required).
 Ability to multi-task and manage priorities
 Strong organizational skills and attention to detail
 Flourishes in a highly dynamic and small company environment
 Familiarity with ISO 13485 compliant Quality Systems
 Familiarity with 21 CFR Part 820 compliant Quality Systems
 Prior experience using IS0-13485 design and development processes
 PMP Certification (a plus, but not required)
 Knowledge of fluorescent reagents or imaging (a plus, but not required)

1505 O’Brien Drive. Suite A1, Menlo Park, CA 94025 | 855.896.8401 | http://www.akoyabio.com | 100 Campus Drive, 6th Floor, Marlborough, MA 01752

Job Type: Full-time

Experience:

• project management: 2 years (Required)

Education:

• Bachelor’s (Required)

License:

• Project Management Professional (PMP) (Preferred)

Work authorization:

• United States (Required)