Senior Manager, NP&LCM Portfolio Lead

Pfizer • Sanford, MA

1d • Hybrid

About The Position

At Pfizer, our mission is to cultivate a best-in-class culture of continuous improvement and project management, empowering colleagues and streamlining processes. Whether managing projects or driving strategic initiatives, your role in this team is crucial in simplifying and accelerating our work. This enables us to deliver breakthroughs that transform patients' lives. Your contributions make our operations more efficient and effective, driving us towards our goal of making a significant impact on healthcare.

Requirements

• BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience
• Demonstrated ability to effectively lead matrix teams, ensuring successful completion of major programs / projects as part of a team and/or project leadership role.
• Experience leading highly accelerated or high complexity projects.
• Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations; able to build effective relationships and influence stakeholders at all levels of the organization.
• Able to develop solutions to complex problems using ingenuity, innovation, creativity, and leadership skills.
• Extensive technical and industry-specific expertise in drug development and/or manufacturing.
• Specific experience in large-molecule/biologic products and combination products/devices are required.
• Understanding of process of developing large-molecule drugs and CMC requirements.
• Flexible and adaptable to changing priorities and timelines (acceleration/deceleration), meeting deadlines, and working well under pressure.
• Comfortable working independently on high complexity assignments.
• Adept at developing processes necessary to accomplish goals.
• Simplifies complex processes.
• Skilled at organizing people and activities.
• Demonstrated ability to identify opportunities for synergy and integration.
• See and understand broader trends (organizational, run the business, improve the business) and come up with proactive solutions.
• Effective written and verbal communication skills. Clearly and concisely summarize complex issues, key outcomes, and importance to the audience, including senior leaders; able to work with different cultures.
• 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.
• Permanent work authorization in the United States.

Nice To Haves

• Experience with DS and DP development & scale-up of large-molecule products.
• Experience with technical transfer of large-molecule products.
• Experience with co-development process for new large-molecule products.
• Experience with Pfizer budget processes, including managing project budgets (expense spending and FTEs).
• Understanding of Business Development processes.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• 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

• Serve as the primary PGS representative in developing and leading late-stage large-molecule product development, ensuring PGS considerations are reflected in Co-Development project plans across all technologies (Drug Substance/Analytical/Drug Product/Packaging) in partnership with Pharm Sci & PGS.
• Lead the cross-functional Co-Development Team (CDT), which is product-focused, and is responsible for PGS input into CMC strategy development and execution, as well as the overall CMC budget of the CDT.
• Drive PGS input to product strategy and provide this input across the co-development process, including development, manufacturing and regulatory submission content to deliver the Quality Target Product Profile (QTPP), Validation and Launch strategies, knowledge management (including delivery of Process Understanding Plans (PUPs)), project timelines, key project milestones, and lessons learned.
• Serve as the primary technical PGS representative in managing in-line, or marketed, products, ensuring PGS technical considerations are reflected in Technology Lifecycle plans across all technologies (Drug Substance/Analytical/Drug Product/Packaging) in partnership with other PGS functions.
• Lead a PGS cross-site and cross-functional product-focused team and is responsible for facilitating evaluation & implementation of technical projects related to product supply (including product quality/compliance) and/or cost-savings and understanding & communicating product risks & project milestones.
• Build relationships with business line partners (Business Units, Pfizer Research & Development (PRD), Pfizer Global Supply (PGS) functions and manufacturing sites, and Biotherapeutic Pharmaceutical Sciences (BTxPS) to advocate for the strategies, plans and timelines of Co-Development Team(s) & Technology Team(s).
• Develop and lead complex projects, creating and managing plans to achieve objectives.
• Manage and oversee the operational aspects of ongoing improvement projects, acting as a liaison between project teams and line management.
• Support programs by managing project status reviews, budgets, schedules, and preparing necessary reports.
• Develop mechanisms for monitoring project progress, intervening, and problem-solving with project managers, line managers, and clients.
• Facilitate the development, implementation, and management of business strategies, coordinating project plans with cross-functional teams to deliver on time and within budget.
• Execute communication plans to ensure effective and timely communication among the core team, functional management, senior management, and external partners.
• Promote a continuous improvement culture, streamline processes for maximum efficiency, and provide project information to support portfolio-level decision-making and prioritization.
• Lead the Co-Development Team (CDT) & represent PGS technical on the Product Team (PT).
• As the PGS lead on the cross-functional matrix CDTs, work closely with BTxPS, manufacturing sites, GMTs, and Business Unit, to evaluate technology and processes to transfer, validate, and submit CMC regulatory modules to health authorities, gain marketing approval, and launch new small-molecule products and in some cases support post approval major product enhancements of marketed products (e.g. new devices / formulations, line extensions).
• Provide PGS input into CMC strategy development, execution, and CMC budget.
• Serve as PGS point of contact to enable delivery of clinical supply plan for pivotal / Phase 3 studies.
• Provide PGS input into communications and alignment with key stakeholders, including in escalation of major changes and issues, project risks and opportunities.
• Provide PGS input into decision making in environment of competing priorities and varying levels of ambiguity.
• Partner with the Pharm Sci Team Leader (PSTL) to transition into Co-Development and also partner with the Product Portfolio Lead(PPL) in Marketed Product Support to create highly empowered and cohesive team(s) that can rally behind a compelling vision.
• Represent PGS on the CDT to help develop Co-Development plans including ICH and validation strategy for CDTs.
• Represent PGS technical on the PT to help develop Technology Lifecycle plans, including key projects related to supply continuity & cost-savings.
• Develop and track at-risk spend for pre-launch inventory as part of the op planning process.
• Represent PGS on Joint Alliance Teams as needed (i.e. Joint Development Team, Joint Supply Chain Team, Joint Steering Team).
• Lead Alliance Joint Manufacturing Committee as needed.
• Lead key strategic projects / initiatives with ambiguous scope to enable Pfizer Purpose Blueprint and deliver value to organization, as needed.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• 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
• Relocation assistance may be available

What This Job Offers

• Job Type: Full-time
• Career Level: Senior