Technical Transfer Specialist - Manufacturing Operations

Avispa Technology•Tucson, AZ

2d•Onsite

About The Position

A leading biotechnology company is seeking a Technical Transfer Specialist - Manufacturing Operations to support the introduction of new assays, reagents, and bulk materials for tissue diagnostics into the company's manufacturing processes. This role ensures the seamless integration of new products from Development into Operations, focusing on manufacturability, quality, cost, and schedule, and leveraging technical knowledge, project management skills, and lean manufacturing principles to support efficient, scalable, and compliant manufacturing practices.

Requirements

1+ year of relevant experience in pharmaceutical, biotechnology, or medical device environments.
Bachelor’s or Master’s degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry) or Engineering (Biomedical, Chemical).
Experience operating within GMP or other regulated manufacturing environments.
Knowledge of Lean principles; familiarity with Six Sigma methodologies is preferred.
Foundational understanding of process transfer, design for manufacturability, and end-to-end production processes (e.g., formulation, filling, packaging).
Experience following SOPs, quality protocols, and regulatory requirements to ensure compliance and data integrity.
Experience with technical documentation and report writing.

Responsibilities

Execute product design transfer activities from late-stage development through commercial launch, coordinating process transfers from R&D to manufacturing sites and tracking project milestones.
Collaborate cross-functionally with Operations, Development, Regulatory, and Project teams to align on manufacturability, quality, cost objectives, and end-to-end manufacturing requirements, including scalability considerations.
Apply project management methodologies to execute transfer activities, troubleshoot issues, and support the evaluation and implementation of new tools and technologies.
Support process validation readiness and audit compliance by gathering documentation, assisting with non-conformance investigations (NCRs), and ensuring adherence to cGMP, local/international regulations, and internal standards.
Analyze process data using statistical tools (e.g., Minitab) and apply Lean methodologies (e.g., Five Whys, Fishbone) to identify inefficiencies, minimize risk, and drive continuous improvement.
Develop, maintain, and standardize process documentation and procedures while contributing to team knowledge through training and mentorship initiatives.