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Employment Requirements
This opportunity is not open to C2C relationships or visa sponsorship.
This opportunity is for local candidates only.
Job Description
Our partner ranks among the world’s prominent corporations in the biotechnology industry. Working on their team means you’ll impact the lives of millions of patients and be a part of a culture of innovation, curiosity, and diversity.
Our partner is seeking a Technical Transfer Specialist - RTD to support coordination between Manufacturing Operations and Development, Regulatory, and Project teams. This role plays a critical part in launching new assays, reagents, and bulk materials used in tissue diagnostics by ensuring that manufacturing requirements are met in terms of quality, cost, and timelines. While not performing hands-on testing, the Specialist will serve as a key interface, managing process validations and driving cross-functional collaboration. Success in this role requires a strong foundation in process validation, Good Documentation Practices (GDP), Good Handling Practices (GHP), Agile methodology, and excellent communication and project coordination skills.
Responsibilities
• Understand and communicate manufacturing best practices and site requirements to ensure manufacturability and scalability.
• Serve as the Global Operations focal point to represent stakeholders such as Manufacturing, Process Engineering, Quality, Procurement, and Planning throughout the transfer process.
• Learn and apply Technology Transfer standard work to enhance and streamline project execution.
• Support project management efforts to plan, track, and deliver transfer projects on schedule.
• Develop expertise in site manufacturing processes to promote and train on GMP principles and ensure cost-effective, high-quality outcomes.
• Provide input during the design phase of development projects to ensure design for manufacturing considerations are incorporated.
• Execute validation protocols in alignment with GMP standards and support from fellow Technical Transfer Specialists.
• Participate in cross-functional teams to ensure technology transfer project needs are met and collaborate with lifecycle, regulatory, and other business units.
• Troubleshoot transfer-related issues, support process updates, and deliver project status presentations to diverse stakeholders.
• Assist leadership with project coordination tasks including scheduling, resource tracking, assignment monitoring, and conflict resolution.
• Support workflow standardization, implement efficiency improvements, and promote best practices across projects.
• Explore and apply appropriate project management tools.
Qualifications
• Bachelor’s degree in Engineering, Engineering Technology, or Life Science with 1–3 years of experience, or Master’s degree in the same disciplines with 0–2 years of experience.
• Demonstrated potential for technical proficiency, scientific creativity, and independent problem-solving.
• Basic understanding of assay, bulk, and reagent manufacturing processes and design, and ability to apply scientific method to production environments.
• Advanced technical writing skills to create accurate and detailed reports and documentation.
• Understanding of 6 Sigma and Lean Manufacturing methods, with ability to apply these during development phases.
• Experience using systems such as SAP and ETQ.
• Background in science or manufacturing is preferred over engineering.
• Experience with Agile methodology is highly desired.
• Familiarity with Process Validation, GHP, and GDP is required.
• Strong soft skills and the ability to communicate effectively across teams is essential.
This opportunity is not open to C2C relationships or visa sponsorship.
This opportunity is for local candidates only.
Job Description
Our partner ranks among the world’s prominent corporations in the biotechnology industry. Working on their team means you’ll impact the lives of millions of patients and be a part of a culture of innovation, curiosity, and diversity.
Our partner is seeking a Technical Transfer Specialist - RTD to support coordination between Manufacturing Operations and Development, Regulatory, and Project teams. This role plays a critical part in launching new assays, reagents, and bulk materials used in tissue diagnostics by ensuring that manufacturing requirements are met in terms of quality, cost, and timelines. While not performing hands-on testing, the Specialist will serve as a key interface, managing process validations and driving cross-functional collaboration. Success in this role requires a strong foundation in process validation, Good Documentation Practices (GDP), Good Handling Practices (GHP), Agile methodology, and excellent communication and project coordination skills.
Responsibilities
• Understand and communicate manufacturing best practices and site requirements to ensure manufacturability and scalability.
• Serve as the Global Operations focal point to represent stakeholders such as Manufacturing, Process Engineering, Quality, Procurement, and Planning throughout the transfer process.
• Learn and apply Technology Transfer standard work to enhance and streamline project execution.
• Support project management efforts to plan, track, and deliver transfer projects on schedule.
• Develop expertise in site manufacturing processes to promote and train on GMP principles and ensure cost-effective, high-quality outcomes.
• Provide input during the design phase of development projects to ensure design for manufacturing considerations are incorporated.
• Execute validation protocols in alignment with GMP standards and support from fellow Technical Transfer Specialists.
• Participate in cross-functional teams to ensure technology transfer project needs are met and collaborate with lifecycle, regulatory, and other business units.
• Troubleshoot transfer-related issues, support process updates, and deliver project status presentations to diverse stakeholders.
• Assist leadership with project coordination tasks including scheduling, resource tracking, assignment monitoring, and conflict resolution.
• Support workflow standardization, implement efficiency improvements, and promote best practices across projects.
• Explore and apply appropriate project management tools.
Qualifications
• Bachelor’s degree in Engineering, Engineering Technology, or Life Science with 1–3 years of experience, or Master’s degree in the same disciplines with 0–2 years of experience.
• Demonstrated potential for technical proficiency, scientific creativity, and independent problem-solving.
• Basic understanding of assay, bulk, and reagent manufacturing processes and design, and ability to apply scientific method to production environments.
• Advanced technical writing skills to create accurate and detailed reports and documentation.
• Understanding of 6 Sigma and Lean Manufacturing methods, with ability to apply these during development phases.
• Experience using systems such as SAP and ETQ.
• Background in science or manufacturing is preferred over engineering.
• Experience with Agile methodology is highly desired.
• Familiarity with Process Validation, GHP, and GDP is required.
• Strong soft skills and the ability to communicate effectively across teams is essential.