Sr. Technology Transfer Lead - Quality Control

Position Overview

The Technical Transfer Senior Lead for Quality Control plays a pivotal role in facilitating the seamless transition of RUO and Clinical products from development to the QC group. This role is a laboratory position that ensures that all transfers meet quality, cost, and timeline objectives while complying with GMP, ISO 13485 and regulatory standards. Responsibilities include planning and managing technology transfers, preparing and maintaining documentation, and supporting validation activities. This individual will serve as the subject matter expert to ensure a robust test method is transferred to QC.  The specialist responds to cross-functional teams—including R&D, Quality, Regulatory, and Operations—to align requirements, troubleshoot technical issues, and driving corrective actions. Additionally, the role involves supporting continuous improvement initiatives to optimize processes and reduce costs.

Core Responsibilities 

• Execute technology transfer initiatives, ensuring timely commercialization of new products and efficient scale-up of existing products.
• Contribute to project oversite, managing all technical components to meet key deliverables and deadlines.
• Design and execute V&V testing, write reports and develop robust product acceptance criteria.
• Serve as the subject matter expert in cross-functional meetings, representing QC interests and providing expert guidance to aid in investigation and nonconformance resolution on QC testing failures.
• Initiate and drive change control for test method and process revision.
• Collaborate with Product Development to design and execute experiments to establish robust acceptance criteria and validation methods for the process transfer. Requires data analysis and monitoring product performance.
• Prepare, review and maintain technical documentation such as protocols, reports, and change management requests.
• Utilize FMEA/Risk Assessment tools to address critical QC test method requirements
• Train QC analysts on NPI test method
• Assist/Create/Perform equipment validation
• Identify improvement areas and gaps in QC to increase/maintain reliability and efficiency

Required Qualifications

• Bachelor’s or Master’s degree in molecular biology, biochemistry, chemistry or related field.
• 7-10 years’ experience of relevant industry experience in Quality Control transfer activities.
• Demonstrated experience in technology transfer and QC resulting in successful product transfer completion.

Preferred Skills and Attributes

• Hands-on experience with molecular biology techniques (e.g. PCR, ELISA) and the handling of oligonucleotides and proteins.
• Proficiency in V&V testing and process monitoring systems.
• Experience in ISO 13485 and GMP environments.
• Familiarity with lab automation and analytical equipment.
• Innovative, self-starter, highly process oriented, organized, and efficient.
• Strong team player with experience leading cross-functional teams with high level of data analysis, problem-solving ability and sound judgement in recommending solutions.
• Excellent verbal and written communication skills with the ability to present complex data to diverse audience. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
• Proven ability to manage multiple projects, prioritize tasks and meet tight deadlines
• Physical capability to move within office and lab environments and occasionally lift up to 25 lbs.

The base salary range for this full-time position is $140,000 - $160,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.