Senior Principal Scientist, Tech Ops (CMC Science) - Recombinant

S enior Principal Scientist, TechOps (CMC Science) – Recombinant

Job Purpose

The Senior Principal Scientist is a recognized technical expert within the Recombinant Integrated Product Team (IPT), providing advanced scientific expertise and leading complex technical activities to support product lifecycle management.

The role contributes to the execution of product strategies by delivering high-quality scientific input, leading defined technical initiatives, and supporting cross-functional decision-making to ensure robust product performance and continuous improvement.

Main Responsibilities & Accountabilities

1. Technical Expertise and Workstream Leadership

• Acts as a subject matter expert in recombinant process science, providing advanced technical knowledge to support complex product-related activities.
• Leads defined technical workstreams or projects within broader product initiatives.
• Delivers high-quality scientific outcomes in line with project objectives, timelines, and performance expectations.

2. Contribution to Product Strategy and Planning

• Contributes technical input to the development and refinement of the product technical roadmap.
• Identifies and evaluates improvement opportunities (e.g., process robustness, yield, compliance) and supports their assessment and implementation.
• Provides scientific input into business cases and supports data-driven decision-making processes.

3. Cross-Functional Collaboration

• Works within a global, matrixed IPT environment, collaborating with Manufacturing, MS&T, Quality, and Regulatory functions.
• Supports alignment of technical activities across sites and functions.
• Engages with stakeholders to ensure effective execution of product-related initiatives.

4. Scientific Oversight and Technical Support

• Ensures application of sound scientific principles and compliance in product lifecycle activities, including process changes and technology transfers.
• Provides input to technical decision-making processes, including change controls, validation strategies, and lifecycle management activities.
• Supports data analysis, process understanding, and technical risk assessments.

5. Continuous Improvement and Innovation

• Contributes to the identification and implementation of process improvements and efficiency gains.
• Applies scientific methodologies and data analysis to improve process consistency and product quality.
• Supports implementation of best practices and innovative approaches within the IPT.

6. Stakeholder Interaction and Communication

• Communicates complex technical information clearly to cross-functional stakeholders.
• Contributes to technical discussions and governance forums as required.
• Builds effective working relationships to support delivery of product objectives.

7. Coaching and Knowledge Sharing

• Provides guidance and informal mentoring to junior scientists and team members.
• Contributes to knowledge sharing and continuous development of technical capabilities within the organization.

Qualifications & Experience Requirements

• PhD in Biochemistry, Biotechnology, Chemical Engineering, or related Life Sciences discipline.
• Typically 8–12 years of relevant experience in biopharmaceutical development and/or manufacturing within a GMP environment.
• Strong expertise in recombinant product process development, manufacturing, and lifecycle management.
• Experience contributing to complex technical projects in a matrix environment.
• Solid understanding of process validation, technology transfer, and regulatory requirements.
• Demonstrates strong project management skills, including planning, coordination, and execution of multiple projects to ensure timely delivery of objectives.

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