Bioprocess Scientist - Advanced Therapies Manufacturing

Role Summary

Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture. The successful candidate will build deep technical expertise in their area of responsibility, possess strong working skills on the manufacturing equipment set and control systems, and apply data-driven decision-making and problem-solving. They may ensure the process is in-control, capable, compliant, and maintained in a validated state, and contribute to implementing new technologies and process improvements in the manufacturing environment.

Responsibilities

• Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products
• Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement)
• Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes
• Work as part of cross-functional teams, and establish partnerships with applicable functions, operations, and development to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team
• Be able to assess whether the process is in control and capable of meeting its stated purpose and is in a constant state of validation
• Identify process improvements and participate in implementation of Lean manufacturing initiatives
• Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents and annual reports
• Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
• Serve as technical interface external to the Lebanon site
• Provide audit support, as needed
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Qualifications

• Required: Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field
• Required: 3+ years of experience in cGMP manufacturing, specifically within Operations, Validation, TS/MS, or Engineering
• Preferred: In-depth knowledge of the science behind the molecule and the processes on mRNA/LNP drug substance manufacturing; understanding of the process control strategy for mRNA/LNP mediated gene therapy products
• Preferred: Experience and understanding of technical challenges with mRNA as a therapeutic modality
• Preferred: Experience with mRNA/LNP formulation
• Preferred: Experience with QC assays in line with product CQAs including variability
• Preferred: Strong interpersonal and teamwork skills
• Preferred: Strong self-management and organizational skills
• Preferred: Strong oral and written communication skills; ability to communicate clearly at all levels
• Preferred: Experience with data trending and analysis; ability to analyze complex data and solve problems
• Preferred: Demonstrated successful membership/leadership of cross-functional teams

Education

• Bachelor's in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or related quantitative field

Skills

• Data-driven decision making and problem solving
• Cross-functional collaboration and technical leadership
• Process validation, tech transfer, and deviation investigations
• Strong communication and documentation skills
• Lean manufacturing mindset and continuous improvement