Sr. Principal Engineer, Tech Transfer

About the Role

Leads the design and execution of formulation and process development activities across the product lifecycle, supporting programs from early development through commercialization and delivering phase-appropriate drug products aligned with target product profiles. Manages end-to-end development activities, including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while supporting external partnerships for clinical and commercial supply. Contributes technical leadership within CMC teams, collaborating cross-functionally to advance programs, support regulatory readiness, and drive continuous improvement, while mentoring junior team members and supporting robust process and product control strategies.

Your Contributions

• Set and drive enterprise-level strategy for drug product formulation and manufacturing across the portfolio, ensuring alignment with corporate objectives, regulatory expectations, and long-term commercial success
• Provide authoritative technical leadership within CMC, guiding program direction from early development through commercialization and lifecycle management, and influencing key decisions at the project and portfolio level
• Define and govern development strategies for formulations and manufacturing processes, applying advanced scientific principles (e.g., QbD, DoE, modeling, and statistical approaches) to establish robust, scalable, and well-controlled processes
• Oversee and ensure successful execution of process development, scale-up, validation, and global technology transfer activities, resolving complex technical and operational challenges to enable reliable clinical and commercial supply
• Lead CMC subteams and influence cross-functional teams, ensuring clear communication of program strategy, risks, timelines, and resource needs to senior leadership and stakeholders
• Serve as a recognized subject matter expert, providing strategic oversight and direction for complex investigations, risk assessments, and issue resolution across development and manufacturing
• Direct external strategy and partnerships, including selection, oversight, and performance management of CDMOs and vendors, ensuring technical excellence, compliance, and alignment with program and portfolio needs
• Provide executive-level oversight and final accountability for CMC regulatory strategy and deliverables (e.g., IND, IMPD, NDA, MAA), ensuring high-quality submissions and successful global regulatory interactions
• Establish and drive lifecycle management strategies, including CPV, CPI, and proactive risk management for critical process parameters and quality attributes, ensuring sustained product performance and compliance
• Champion innovation by identifying, prioritizing, and implementing enabling technologies, advanced manufacturing approaches, and platform capabilities to strengthen organizational effectiveness and competitive advantage
• Lead knowledge management and standard-setting initiatives, fostering best practices, data integrity, and organizational learning across programs and teams
• Mentor and develop scientific staff and emerging leaders, shaping technical capabilities within the organization and serving as a trusted advisor to senior leadership on development strategy, risk, and portfolio prioritization
• Represent the organization externally in regulatory interactions, industry forums, and scientific engagements, influencing technical positioning and enhancing the company’s reputation
• Other duties as assigned

Requirements

• BA/BS degree in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 10+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting
• OR Master's degree in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 8+ years of similar experience noted above
• OR PhD in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 6+ years of similar experience noted above, may include post doc experience

Pay

The annual base salary we reasonably expect to pay is $173,600.00–$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity-based long-term incentive program.

Benefits

• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans