Manufacturing Engineer II Job at Akoya Biosciences in Marlborough

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  

This position is responsible for providing technical support to the reagent manufacturing processes in a Life Sciences Research manufacturing company with a highly complex technology, extensive product portfolio and several strategic collaborations. Functional responsibilities include developing and improving manufacturing processes, performing process verifications/validations, creating bill of material and routings and supporting new product transfer. 

Duties and Responsibilities 

• Develop and maintain specifications, work instructions, process travelers and Device History Records (DHR) for compliance within Akoya ISO13485/21 CFR 620 environment using Arena Product Lifecycle Management (PLM) 

• Provide technical support and failure analysis for on market product 

• Develop manufacturing processes based on product requirements 

• Develop / Improve testing and quality control measures for reagents 

• Create process control and method to monitor and improve processes for quality and efficiency 

• Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout 

• Establish and perform process verification and process validations 

• Support new product introduction activities 

• Train technicians on new processes as needed to support manufacturing 

• Support quality system compliance including material dispositions, change order implementation, and nonconforming evaluations 

• Other duties as assigned 

Qualifications/Skills  

• Bachelor’s Degree in Biochemistry, Chemistry, Chemical/Biomedical Engineering or the equivalent combination of education, experience and/or training 

• 2-5 years’ experience in Manufacturing operations environment; Biologic and/or chemical conjugations preferred 

• Experience with HPLC, FPLC, and/or Mass Spec preferred 

• Experience with GMP- or ISO-certified operations preferred 

• Experience with Lean Manufacturing and Continuous Improvement preferred 

• Excellent communication skills 

• Ability to work well under pressure 

• Strong working knowledge of MS office 

• Strong technical problem-solving skills 

The hiring range for this position is $84,000 - $105,000 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.