Sr Manager, CRD Operations and External Development

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 efficient execution viaa blend of internal and external (CDMO) staff.
• Manages scientific resources for one or more external development projects, ensuring strong integration of chemistry, analytical and engineering expertise. Adjusts project team size and construct to deliver results while ensuring budgetary targets are met.
• Uses knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions for the effective delivery of the portfolio via external development partnerships.
• Develops and exhibits a high level of business knowledge and understanding of CRD Manufacturing and PGS to meet customer requirements for development and manufacturing of small molecule APIs.
• 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.

Communication

• Actively shares knowledge across CRD, PSSM, Medicine Design and PGS to ensure effective design and execution.
• Actively engages with industry peers in pre-competitive space 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 with strong collaboration across Co-Development and with clear communication of risks and mitigation strategies to the Portfolio Delivery Team (PDT). Contributes to a communication-rich environment to ensure the knowledge and expertise of the entire team is leveraged.
• Contributes to the continuous improvement of external API Development Workflows and processes to enhance Co-Development, and regulatory and technical success.

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. Is acknowledged as an expert in the pharmaceutical development process.
• 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. Able to leverage technical and functional expertise across own and related disciplines. Innovative and creative approach to problem solving (both business & scientific), with ability to impact and influence within the global line and outside of the department.
• Ability to lead in a rapidly changing environment & communicate positive advantages of change. Early adopter of new technologies/ways of working to enhance business productivity.
• 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, computational chemistry, biocatalysis and/or high throughput experimentation.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, oversee and guide the work of others, and create positive business impact.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform complex tasks with appropriate mental agility, including mathematical calculations and complex data analysis. High change agility.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Will be required to occasionally travel domestically and internationally (5-10%) to support establishment and optimization of CDMO relationships, project team objectives and Co-Development business processes, including API manufacturing campaign preparations.

Work Location Assignment: On Premise at an active Pfizer site, with relocation assistance available
Additional Information

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
• Please note there is no relocation support available for this position

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Research and Development