Associate Engineer/Scientist, Process & Product Transfer
Job description
About the role
You will spearhead the execution of design transfer activities for novel immunoassay products moving from development into commercial manufacturing. This position requires you to own the end-to-end documentation and validation strategy that ensures seamless technology transfer. You will be responsible for scaling reagent production and defining clear acceptance criteria for every critical material. Your work will directly influence the robustness and reproducibility of assays that impact clinical decision-making. You will partner closely with quality and regulatory teams to ensure all deliverables meet strict regulatory standards. In this role, you will drive continuous improvement initiatives that optimize yield, reduce cost of goods, and enhance process control.
Key facts
What you'll do
-Own the end-to-end product transfer strategy for new introductions, aligning design transfer deliverables with the internal Product Development Process.
-Define and establish raw material and in-process material specifications alongside acceptance criteria to guarantee consistent product quality.
-Translate complex assay designs into detailed manufacturing work instructions and in-process test protocols that are intuitive for production staff.
-Execute scaled reagent builds during feasibility studies, maintaining rigorous batch record compliance with current Good Manufacturing Practice (cGMP) standards.
-Plan and conduct process verification campaigns to prove assay robustness, reproducibility, and performance consistency at manufacturing scale.
-Manage material consumption and inventory transactions to prevent shortages and ensure traceability throughout the transfer lifecycle.
-Drive lean manufacturing projects that target cost reduction, efficiency gains, and improved yield across the production workflow.
-Lead root cause investigations for deviations encountered during transfer, coordinating with cross-functional teams to implement effective resolutions.
-Create and maintain electronic records for work instructions, and develop data analysis templates that minimize human error and streamline reporting.
-Perform detailed reviews of batch records, working with Quality Assurance to resolve deviations, non-conformances, and corrective actions before release.
-Ensure all process documentation remains accurate, complete, and compliant with FDA, ISO, and other applicable regulatory requirements.
-Provide active support during regulatory audits, inspections, and regulatory submission activities as required by the business.
Requirements
-You hold a Bachelor's or Master's degree in Bioengineering, Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a closely related technical field.
-If your qualification is a Bachelor's degree, you must bring a minimum of 3 years of relevant industry experience to this role.
-If your qualification is a Master's degree, you must have at least 1 year of relevant industry experience in a regulated environment.
-Your background must include product or technology transfer experience within the diagnostics sector, IVD, or RUO assay manufacturing.
-You must have direct experience working under cGMP regulations and understand the associated quality systems.
-You should be familiar with process validation principles, statistical analysis techniques, and continuous improvement frameworks such as Lean or Six Sigma.
-Strong project management skills are essential to coordinate timelines, dependencies, and cross-team interactions.
-You must have a solid grasp of design controls and how they apply to the product development lifecycle in regulated industries.
-Familiarity with Good Documentation Practices (GDP), cGMP, FDA, and ISO quality standards for medical devices and IVD products is mandatory.
-Exceptional attention to detail is required to maintain accuracy and consistency in documentation and batch record execution.
-You must possess strong analytical and problem-solving abilities to troubleshoot technical challenges and implement corrective actions.
-Excellent verbal and written communication skills are necessary to collaborate effectively with multi-functional teams.
-You must be proficient in Microsoft Excel for building manufacturing records, data analysis templates, and performing basic statistical calculations.
-Experience with AI tools to support process automation is preferred, provided there is appropriate human oversight and validation.
Nice to have
-Practical experience with Successive Proximity Extension Amplification Reaction (SPEAR) technology is a strong advantage.
-Knowledge of wash-free immunoassay formats and their manufacturing implications.
-Familiarity with CLSI guidelines and clinical laboratory standards.
-Experience supporting regulatory submissions, audits, and inspections for IVD products.
Practical notes
This is a full-time position based at our headquarters in Woburn, Massachusetts. The role does not involve travel requirements or visa sponsorship at this time. There are no published deadlines for application submission, and interested candidates are encouraged to contact the hiring team directly through company channels.