Process and Analytical Technology Transfer Lead

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Job Title: Process and Analytical Technology Transfer Lead

Location: Boston, MA

Job Description:

The Process and Analytical Technology Transfer Lead will lead and support the transfer of drug substance, drug product, and/or medical device processes and QC analytical methods into commercial manufacturing facilities.  Customers may be internal or external partners, and the transfer may exist from clinical production through process performance qualification and commercial operations.   

Key Responsibilities:

• Site representation in global technology transfer process.
• Subject matter expert (SME) for Technology Transfer and Analytical Method Validation
• Implement programs for smooth transition of analytical methods into full production readiness, representing MS&T in Tech Transfer projects.
• Collaborate with the team to ensure that method transfer optimizes the process in terms of efficiency, cycle time, reliability, and serviceability.
• Process Technical Transfer: Lead and support cross-functional tech transfer for upstream and downstream processes.  Generate and review tech transfer documentation, such as tech transfer plan, gap/risk assessments and validation plans/protocols.  Serve as subject matter expert on process and provide technical oversight at receiving manufacturing site. 
• Analytical Method Transfer Management: Lead and coordinate the end-to-end process of transferring analytical methods from either internal production or across external sites. Develop and support analytical method tech transfer and execution, including method verification, transfer and validation.  Identify analytical needs and perform risk and gap assessments.  Collaborate cross functionally with product sciences, quality control, and quality teams to ensure the robustness of new technologies. Ensures all deliverables are in place prior to each project milestone.
• Project Management: Create detailed project plans and timelines for tech transfer activities and communicate progress to stakeholders. Track project deliverables, identify and address roadblocks, and ensure all actions are completed on time.
• Documentation & Compliance: Serve as SME to review, author and deliver SOPs, transfer plans, protocols, reports and transfer summary reports.  Ensure compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA). Support regulatory requests and inspections.
• Cross-Functional Collaboration: Coordinating subject matter experts within Product Sciences, Quality Control, MS&T, Quality and Regulatory Affairs and other site related functions or experts, to ensure that requirements are met.  Support best practices for tech transfer and method validation as required.
• Troubleshooting & Problem Solving: Identify potential risks in the method transfer process and develop mitigation strategies. Support the QC team to investigate any project challenges with appropriate risk assessment tools. 
• Training & Support: Ensure that receiving sites are adequately trained on new methods or technologies.  Provide technical expertise and leadership to teams throughout the transfer phases.
• Continuous Improvement: Lead efforts to continuously improve technology transfer processes, ensuring the implementation of best practices. Evaluate and implement process improvements to reduce transfer time and enhance product quality.

Skills and Qualifications:

• Bachelor’s or Master’s degree or PhD in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Biological Sciences, Chemical Engineering, or a related discipline with approx. 6-10 years of experience in a pharmaceutical, biopharmaceutical, medical device or manufacturing environment.
• Experience including method validation, process validation, transfer, commercialization and manufacturing support and troubleshooting
• Knowledge of regulatory standards and GMP guidelines
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Excellent problem-solving skills and attention to detail.
• Strong leadership, organizational, and communication skills.
• Ability to work effecti