Associate Research Fellow, Process Chemistry, Chemical Process and Analytical Development

Role Summary

Role Summary: Associate Research Fellow, Process Chemistry, within Pfizer's Chemical Process and Analytical Development (CPAD) group in Bothell, WA. Responsible for leading and mentoring a team of process chemists in route ideation, screening, selection, development, and characterization of drug-linker synthesis for Antibody-Drug Conjugates (ADCs). Collaborates with CPAD leadership to implement data-rich experimentation and process analytics to accelerate development and enable scalable, phase-appropriate manufacturing. Oversees technology transfer and campaign execution at internal facilities and CDMOs.

Responsibilities

• Directly lead and supervise 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 FTEs, 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-Linker development to deliver robust processes while ensuring business continuity and compliance with quality and global regulatory requirements.
• Collaborate with internal stakeholders (Discovery Chemistry, Chemical Research and Development in Groton, CT, Conjugation Process Development, Quality, Pfizer Global Supply, Reg CMC) to 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 good working knowledge 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 (infrastructure, CapEx planning, Lab Safety and Operations).
• 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.

Qualifications

• Required: Ph.D. in Organic Chemistry, or a related field; 10+ years of experience in pharmaceutical process chemistry.
• Preferred: Experience with Drug-Linkers for ADCs, or related high-potent molecules.
• Required: In-depth knowledge of drug development from pre-clinical to commercialization with a sound understanding of modern synthetic organic chemistry and physical organic chemistry principles, process chemistry, engineering, analytical and purification technologies including preparative chromatography, and technology transfer.
• Preferred: Experience in late-phase chemical process development and NDA/BLA submissions.
• Preferred: Experience and proven track record in innovation as evidenced by a strong publication record.
• Required: Experience managing, leading and mentoring scientific staff in an interdisciplinary matrix environment.
• Required: Excellent written and oral communication skills, with experience effectively connecting and collaborating with internal and external stakeholders.
• Preferred: Demonstrated breadth of diverse leadership experiences and capabilities including the ability to influence and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Education

• Ph.D. in Organic Chemistry, or a related field.

Skills

• Process chemistry
• Analytical chemistry
• Engineering collaboration
• Scale-up and technology transfer
• Quality by Design (QbD) principles
• Regulatory and CMC awareness across development phases
• Cross-functional collaboration and stakeholder management