Director, Process Chemistry, Chemical Process and Analytical Development
- United States - Washington – Bothell
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.
Qualifications
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, technology transfer, as well as global regulatory requirements.
Experience with a risk-based approach to process developmentand product quality control.
Experience in late phase chemical process development and NDA/BLA submissions.
Experience and proven track record in innovation as evidenced by a strong publication record.
Experience managing, leading and mentoring scientific staff, both directly and in an interdisciplinary matrix environment.
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.
Relocation support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.