Tech Transfer Lead

Tech Transfer Role

The tech transfer role includes the management and coordination of activities for products transferred into large scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification / commercial). This involves managing between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.

Job Description

What You'll Do

Leads and supports technology transfer (TT) across multiple unit operation

Coordinates and leads regular meetings for TT programs with key stakeholders

Develops process performance qualification (PPQ) strategies specific for each program in collaboration with internal stakeholders and customers

Develops project plans that integrates with other scheduling functions within the organization and in alignment with program scope

Escalates risks and tracks milestone progress and ensure cross functional communication to key stakeholders

Supports Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, as required

Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques

Reviews and documents process performance and product health through process trending, monitoring, and supporting annual product reviews

Serves as point of contact to customer and internal regulatory team for technical aspects of the program

Identifies continuous improvements opportunities

Supports best practices for TT and PPQ strategies globally, as required

Coordinates, plans, and supports manufacturing process validation runs

Facilitates technical risk assessments for new manufacturing processes

Contributes to the management of manufacturing data (e.g., databasing) and the statistical analysis aimed at both process monitoring and continued process verification

Writes documentation for internal and external use, such as manufacturing campaigns summary reports, PPQMP (Process Performance Qualification Master Protocol and reports, impact assessments etc.

Interprets and utilizes new knowledge to promptly drive data-based decisions

Collaborates with manufacturing department to support commercial and clinical manufacturing campaigns

Other duties, as assigned

Minimum Requirements

Bachelor's degree in engineering, Life Science or Chemical Engineering with 5 years of relevant experience (e.g., manufacturing); or Master's degree with 3 years of experience; or PhD with no prior experience

Preferred Requirements

Experience working in a Good Manufacturing Practices (GMP) environment

Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting

Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

Experience with root cause analysis (RCA) and risk management tools

Working & Physical Conditions

Ability to discern audible cues.

Ability to conduct activities using repetitive motions that include writs, hands and / or fingers.