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

Pfizer • Bothell, WA

72d • $156,600 - $261,000

About The Position

Our Bothell, WA based Chemical Process and Analytical Development (CPAD) group 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. As an Associate Research Fellow, Process Chemistry you 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 liaise with the CPAD LT to drive the implementation of 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.

Requirements

• Ph.D. in Organic Chemistry, or a related field with 10+ years of experience in pharmaceutical process chemistry.
• Experience with Drug-Linkers for ADCs, or related high-potent molecules is a plus.
• 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.
• Experience in late phase chemical process development and NDA/BLA submissions is preferred.
• Experience and proven track record in innovation as evidenced by a strong publication record.
• Experience managing, leading and mentoring scientific staff in an interdisciplinary matrix environment.
• Excellent written and oral communication skills, with experience effectively connecting and collaborating with internal and external stakeholders.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees