Biologics Process Development Scientific Lead

Job Description

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:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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