Biologics Process Development Scientific Lead

Job Description

The Biologics Process Development Scientific Lead provides technical leadership across biologics process development programs, ensuring functional alignment, leveraging established technology platforms, and sharing knowledge and expertise across projects. The role drives mechanistic understanding, innovation, and platform evolution to support a broad pipeline, partnering closely with upstream and downstream process development to promote integrated strategies and scalable manufacturing solutions.

• 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 leverage technology platforms, standardized methodologies, and prior knowledge for speed, consistency, and efficiency.
• 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, and 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.

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.

• 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.

• Experience leading platform process strategies across multiple biologics programs.
• Familiarity with Design of Experiments (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.

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

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

We are an Equal Employment Opportunity Employer. We provide equal opportunities for all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements and provide accommodations as needed during the hiring process.

The salary range for this role is $ – $. Successful candidates will also be eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

Visa sponsorship is available for qualified candidates.