Job Description

We are seeking a new Senior Manager to help lead Operations & External Development (OED) within Chemical Research and Development (CRD) in Groton, CT, USA. The successful candidate will partner with the Process Chemistry & Technology (PCT) and CRD Management Teams to guide portfolio and operational deliverables, primarily through building and enhancing effective external development partnerships. CRD, as part of Pharmaceutical Sciences Small Molecule (PSSM) within Pfizer Research & Development (PRD), is responsible for the development of process technology for production of Active Pharmaceutical Ingredient (API). CRD leaders engage in all facets of development from small scale synthesis in support of early clinical assessment, to development of robust API processes for commercial scale manufacture. CRD leaders partner with manufacturing specialists in kilo-lab and pilot plant facilities, as well as provide oversight for technology transfer to Pfizer manufacturing sites and third-party facilities. The successful candidate will guide one or more diverse teams of scientists primarily at Chemical Research & Manufacturing Organizations (CDMOs), ensuring clear accountability for, and oversight of, laboratory activities focused on route and process design following the CRD API development workflows. The OED Sr Manager will ensure effective process understanding and transfer of commercial processes to our Pfizer Global Supply (PGS) partners, with accountability for advancement of programs through the API Development Workflows. They will ensure effective resource allocation, portfolio prioritization, development strategy, regulatory documentation, safety, and compliance in the delivery of robust and high-quality processes for APIs through CDMOs. They will ensure effective tracking of, and feedback on, CDMO performance to demonstrate business value and successful progression of projects. They will bring strong knowledge and expertise in Quality by Design and control strategy, including a strong and contemporary working knowledge of ICH guidelines. They will be a proven leader, ensuring effective performance, engagement, and continuous improvement of external development partners. They will be an active member of the PCT Management Team to partner with Engineering, Global External Supply and CRD Manufacturing to ensure smooth operation of the department. They will be accountable for building, communicating and adhering to annual budget targets for externalized API development. The OED Sr Manager serves as a CRD Accountable Manager, assuring overall portfolio progression through effective resource application, with a primary focus on progression of small molecule development assets utilizing a preferred network of CDMOs.

Role Responsibilities

Critical Thinking

• Sets goals, objectives, and priorities for the delivery of our portfolio, ensuring effective route and process design to support clinical development, regulatory submission and new product launch. Serves as CRD Accountable Manager to ensure one or more projects progress to agreed milestones, with a primary focus on supporting external development.
• Provides technical and functional expertise within CRD, ensuring sound process chemistry and Green Chemistry principles are applied to the portfolio, in alignment with ICH guidelines.
• Leverages technical and functional expertise from PSSM, Medicine Design and PGS to ensure effective development of commercial routes and processes.
• Considered a subject matter expert in process chemistry, process engineering or analytical research & development.
• Takes appropriate business risks to achieve desired results, ensuring safety and project delivery at all stages of development. Guides Pfizer and CDMO scientists regarding acceptable levels of risk-taking.
• Develops solutions to optimize the balance of speed, cost, and quality, integrating CRD technology advances such as computational chemistry, robotics & automation, continuous processing, biocatalysis, chemical synthesis innovation and high throughput screening in the advancement of clinical drug candidates.
• Ensures effective technical transfer of commercial processes to PGS, including accountability for regulatory submissions, knowledge management, adherence to regulatory guidance and support of regulatory queries.
• Generates realistic and balanced forecasts for near, mid, and long-term resource needs, and effectively constructs and operationalizes portfolio budgets to ensure efficient, effective advancement of endorsed projects.

Leadership

• Collaborates across PSSM, Medicinal Design and PGS to deliver a cohesive strategy for portfolio delivery through effective use of external resources.
• Is a CRD Accountable Manager for one or more portfolio programs, ensuring effective portfolio delivery and effici