Pfizer, S.A. de C.V
Sr Manager, CRD Operations and External Development
Pfizer, S.A. de C.V, Groton, Connecticut, us, 06349
Sr Manager, CRD Operations and External Development
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.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. 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.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.Develops solutions to optimize the balance of speed, cost, and quality.Ensures effective technical transfer of commercial processes to PGS, including accountability for regulatory submissions.Generates realistic and balanced forecasts for resource needs, and effectively constructs and operationalizes portfolio budgets.Leadership
Collaborates across PSSM, Medicinal Design and PGS to deliver a cohesive strategy for portfolio delivery.Is a CRD Accountable Manager for one or more portfolio programs.Manages scientific resources for one or more external development projects.Uses knowledge of industry and customer requirements to adapt and implement strategic actions for effective portfolio delivery.Develops and exhibits a high level of business knowledge and understanding of CRD Manufacturing and PGS.Demonstrates diverse leadership experiences and capabilities.Communication
Actively shares knowledge across CRD, PSSM, Medicine Design and PGS.Actively engages with industry peers to develop and enhance global best practices.Ensures strategic decisions on projects are supported by the CRD Leadership Team (LT).Contributes to the evolution of workflow and best practice.Contributes to the continuous improvement of external API Development Workflows and processes.Qualifications
Required Education/Experience
PhD Chemist, Analyst or Chemical Engineer with a minimum of 10 years relevant pharmaceutical research & development experience in small molecule API.BSc/MSc Chemist, Analyst or Chemical Engineer with a minimum of 15 years relevant pharmaceutical process research & development experience in small molecule API.Required Technical Skills
Recognized as a strong scientific leader within the API process development community.Contemporary awareness of significant scientific developments and opportunities in chemistry, analytics and/or chemical engineering.A highly credible technical functional expert with experience in mentoring others.Ability to lead in a rapidly changing environment & communicate positive advantages of change.Possesses significant API manufacturing, commercialization, Technology Transfer and Regulatory Dossier authorship and/or review experience.Experience working on large, complex, cross-disciplinary matrix teams.Preferred Technical Skills
Expertise in pharmaceutical process development, continuous process development and manufacturing.Candidate demonstrates a breadth of diverse leadership experiences and capabilities.PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex tasks with appropriate mental agility, including mathematical calculations and complex data analysis.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSWill be required to occasionally travel domestically and internationally (5-10%).
Work Location Assignment: On Premise at an active Pfizer site, with relocation assistance available.
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We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.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. 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.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.Develops solutions to optimize the balance of speed, cost, and quality.Ensures effective technical transfer of commercial processes to PGS, including accountability for regulatory submissions.Generates realistic and balanced forecasts for resource needs, and effectively constructs and operationalizes portfolio budgets.Leadership
Collaborates across PSSM, Medicinal Design and PGS to deliver a cohesive strategy for portfolio delivery.Is a CRD Accountable Manager for one or more portfolio programs.Manages scientific resources for one or more external development projects.Uses knowledge of industry and customer requirements to adapt and implement strategic actions for effective portfolio delivery.Develops and exhibits a high level of business knowledge and understanding of CRD Manufacturing and PGS.Demonstrates diverse leadership experiences and capabilities.Communication
Actively shares knowledge across CRD, PSSM, Medicine Design and PGS.Actively engages with industry peers to develop and enhance global best practices.Ensures strategic decisions on projects are supported by the CRD Leadership Team (LT).Contributes to the evolution of workflow and best practice.Contributes to the continuous improvement of external API Development Workflows and processes.Qualifications
Required Education/Experience
PhD Chemist, Analyst or Chemical Engineer with a minimum of 10 years relevant pharmaceutical research & development experience in small molecule API.BSc/MSc Chemist, Analyst or Chemical Engineer with a minimum of 15 years relevant pharmaceutical process research & development experience in small molecule API.Required Technical Skills
Recognized as a strong scientific leader within the API process development community.Contemporary awareness of significant scientific developments and opportunities in chemistry, analytics and/or chemical engineering.A highly credible technical functional expert with experience in mentoring others.Ability to lead in a rapidly changing environment & communicate positive advantages of change.Possesses significant API manufacturing, commercialization, Technology Transfer and Regulatory Dossier authorship and/or review experience.Experience working on large, complex, cross-disciplinary matrix teams.Preferred Technical Skills
Expertise in pharmaceutical process development, continuous process development and manufacturing.Candidate demonstrates a breadth of diverse leadership experiences and capabilities.PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex tasks with appropriate mental agility, including mathematical calculations and complex data analysis.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSWill be required to occasionally travel domestically and internationally (5-10%).
Work Location Assignment: On Premise at an active Pfizer site, with relocation assistance available.
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