Director, Process Chemistry, Chemical Process and Analytical Development

ROLE SUMMARY

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

The Chemical Process and Analytical Development (CPAD) group located in Bothell, WA is responsible for the development of chemical processes and analytical methods for novel Drug-Linkers (Linker-Payloads) used in Antibody-Drug Conjugates (ADCs) within Pfizer’s oncology portfolio. Our process chemists, analytical chemists, and chemical engineers collaborate to develop innovative phase-appropriate synthetic routes and chemical processes to accelerate the delivery of life saving medicines to patients.

The Director of Process Chemistry will mentor and lead a group of process chemists engaged in route ideation, route screening, route selection, process development and process characterization activities for our growing Drug-Linker portfolio. You will guide the implementation of technologies such as flow chemistry, computational chemistry, data-rich experimentation, high-throughput experimentation and process analytical technology to accelerate process development and enhance process understanding to provide viable scale-specific, phase-appropriate and commercializable manufacturing processes. Additionally, you will oversee tech transfer and campaign execution at internal facilities as well as CDMOs.

Principal Responsibilities

• Directly lead, supervise, and provide career development mentoring for a team of process chemists engaged in the design and development of innovative synthetic routes and processes for the manufacture of novel Drug-Linkers from pre-clinical to commercial

• Lead multi-disciplinary project teams (process chemistry, analytical chemistry and engineering) in the development of phase appropriate processes for novel Drug-Linkers

• Ensure the timely delivery of the project portfolio by effectively assigning resources (people and budget), setting priorities and providing a robust framework for decision making and problem solving. Effectively communicate progress against milestones to internal and external stakeholders.

• Demonstrate expertise in modern synthetic organic chemistry concepts, and process chemistry including scale-up.

• Provide leadership in technology transfer of new processes to internal facilities as well as external CDMOs resulting in Right First Time outcomes. Ensure that processes developed and transferred are safe, robust, and sustainable.

• Foster process understanding by applying principles of Quality by Design to drug substance development to deliver robust processes while ensuring business continuity and compliance with quality and global regulatory requirements.

• Possess, develop and leverage a solid understanding of technologies/platforms/concepts (e.g. high throughput experimentation, flow chemistry, process modeling, statistically designed experiments, PAT) as appropriate to aid and accelerate process development, generate process understanding, and ultimately lead to successful scale-up and effective process control.

• Collaborate with internal stakeholders (Discovery Chemistry, Chemical Research and Development in Groton, CT, Conjugation Process Development, Quality, Pfizer Global Supply, Reg CMC) to implement and deliver material and knowledge across different stages of development.

• Demonstrate the ability to craft strategies to address CMC requirements across different phases (FIH to commercial). Possess solid understanding of the global regulatory environment, and possibly influence it through appropriate forums (e.g. IQ Consortia).

• As a member of the CPAD Leadership Team, provide key input into department strategies in a variety of areas (people development, infrastructure, CapEx planning, Lab Safety and Operations).

• Develop and nurture core competencies of CPAD personnel to ensure appropriate technical capabilities are built.

• Partner closely with peers in Legal, Discovery Chemistry and Pharmaceutical Sciences to develop and implement strategies to protect intellectual property.

• Ensure proactive compliance with all regulatory, safety and environmental regulations and expectations.