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.

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Your Contributions (include, but are not limited to):

• 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

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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 offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.