Biologics Process Development Scientific Lead

Biologics Process Development Scientific Lead

The Biologics Process Development Scientific Lead provides technical leadership across biologics process development programs, with responsibility for driving functional alignment, leveraging established technology platforms, and ensuring knowledge is effectively shared and applied across projects.

This role is expected to help teams build on prior learnings, apply standardized and science-based approaches, and avoid duplicative work or reinvention of established solutions. It is important for this role to drive mechanistic understanding, innovate as needed to support a broad pipeline, evolve the platform to meet evolving needs.

The Scientific Lead partners closely with upstream and downstream process development to support integrated development strategies. The role provides subject matter expertise, influences technical decision-making across the portfolio, and helps ensure processes are robust, scalable, and suitable for clinical and commercial manufacturing.

Key Responsibilities:

• Provide scientific and technical leadership across biologics process development activities, spanning upstream and/or downstream unit operations as applicable.
• Champion platform-based development strategies to promote consistency, efficiency, and application of prior knowledge across programs.
• Drive knowledge sharing and functional alignment across projects to ensure teams are leveraging technology platforms, standardized methodologies, and prior knowledge in order to promote speed, consistency, and efficiency in process development.
• Facilitate knowledge capture, sharing, and transfer across development programs, ensuring lessons learned are incorporated into future work.
• Partner with cross-functional stakeholders to define and align technical strategy, development plans, and portfolio priorities.
• Design, execute, and/or oversee process development studies to improve productivity, product quality, robustness, and scalability.
• Support process optimization, characterization, scale-up, scale-down model development.
• Troubleshoot process challenges, evaluate root causes, and recommend data-driven solutions to improve performance.
• Interpret process, analytical, and manufacturing data to support decisions and communicate recommendations to project teams and leadership.
• Review and approve technical reports, protocols, development summaries, and documentation supporting regulatory filings and manufacturing readiness.
• Support a culture of scientific rigor, collaboration, and continuous improvement across the biologics development organization.

Education:

• PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or a related discipline.
• 15+ years of relevant experience for PhD candidates, or 20+ years for MS/BS candidates, depending on scope and organizational needs.

Required

Experience and Skills:

• Strong experience in biologics process development, with expertise in upstream cell culture/fermentation and/or downstream purification, depending on role focus.
• Demonstrated success in process development and process optimization, scale-up, technology transfer, and platform process development.
• Proven ability to lead across functions, influence without direct authority, and drive alignment across multiple projects.
• Excellent communication, collaboration, and project coordination skills.

Preferred

Experience and Skills:

• Experience leading platform process strategies across multiple biologics programs.
• Familiarity with DoE, statistical analysis, process characterization, and scale-up/scale-down modeling.
• Experience supporting regulatory submissions and cGMP manufacturing.
• Exposure to integrated drug substance development and process lifecycle management.

Required Skills:

Biologics, Cell Cultures, Cross-Functional Leadership, Downstream Processing, Influence, Process Development (PD), Purification Methods, Scientific Thinking, Scientific Work, Technical Leadership, Technology Transfer, Upstream Processing

Preferred

Skills:

Design of Experiments (DOE), Innovation, Platform Scales, Process Flow, Product Lifecycle