Senior Director, Portfolio and Technology Strategy

ROLE SUMMARY

The Senior Director Pilot Development Portfolio Management Technology & Regulatory Strategy is accountable for providing strategic technical and operational leadership across Bioprocess R&Ds nonGMP pilot plants portfolio management and BRDs regulatory and technology strategy. This role ensures that robust scalable and compliant drug substance processes programs and technologies are enabled efficiently from early development through clinical readiness.

The role serves as a single point of accountability for pilotscale execution portfolio alignment and integration of development technologies that support Pfizers biologics vaccines and advanced therapeutic modalities. The role is responsible for coordination and oversight of BRD projects the point of contact to the BTxPS Portfolio group and the interface with the PSPTs. The lead will oversee BRD project forecasts and provide a single point of contact for a cohesive BRD portfolio perspective to BRD LT. The lead will also work with the lines and coordinate the overall Regulatory strategy for BRD and partner with GCMC as the point of contact.

Additionally the role is responsible for coordination and oversight of BRDs Technology Strategy serving as a point of contact to the Pharm Sci Technology and Innovation line and interface with the BTxPS Technology Council. This role will lead development and maintenance of a robust BRD Technology Roadmap for implementing BRDs technology strategy. This role will provide a single point of contact for implementation of a cohesive BRD technology strategy in cooperation with BRD LT.

The role is global in scope and is a core member of the Bioprocess R&D Leadership Team partnering closely with Pharmaceutical Sciences Pfizer Global Supply Regulatory Digital and external collaborators.

ROLE RESPONSIBILITIES

• Lead portfolio operations across BRD ensuring alignment of development priorities pilot capacity resources timelines and execution risk across programs.
• Design and implement metric driven portfolio tracking systems to allow rapid and flexible adjustments to resource allocations according to project prioritizations. The Lead will collaborate with BRD clinical MFG and the BRD LT in the scheduling and prioritization of projects in the non-GMP and GMP pilot plants to deliver the portfolio.
• Serve as the primary contact to BTxPS Portfolio group ensuring that information on new projects and technologies and changes to on-going projects is transferred into BRD in a timely manner. Work with ARD and PhRD portfolio groups to coordinate project initiations at PICM/PPMT and overall project progression through periodic touchpoints
• Work with the BRD LT to manage new BRD rep assignments; triage project issues for prioritization of BRD LT resources on key issues; facilitate forum for strategic input from BRD LT on portfolio
• Provide a mature and experienced perspective on portfolio tracking project issues and prioritization to ensure robust oversight and communication of project milestones deliverables and issues.
• Provide strategic and technical leadership for nonGMP pilot plants enabling effective scaleup process characterization and delivery of drug substance for preclinical and clinical studies.
• Oversee pilot plant readiness including equipment strategy maintenance and turnaround media and buffer support and inventory management across sites.
• Provide strategic leadership for BRD technology strategy ensuring technology choices support portfolio priorities scalability regulatory readiness and future manufacturing translation.
• Define and steward the BRD technology roadmap in partnership with Pfizer Global Supply and Digital including evaluation and deployment of emerging platforms automation analytics and digital enablers.
• Serve as the primary contact to BTxPS technology council ensuring alignment visibility and followthrough on BRD technology initiatives by tracking projects proposals coordinating funding requests and investment decisions through the PSTC
• Develop and implement work plans and strategies in response to new BRD technology initiatives and mentor BRD staff in pursuit of BRDs technology strategy.
• Serve as a point of contact with PGS for BRD initiatives relating to new technologies technology transfer and business practices.
• Oversee BRD legal agreements external partnerships and sponsorships by coordinating execution and tracking NDAs CDAs MTAs and collaboration agreements ensuring timely progress compliance and portfoliolevel visibility
• Leverage exposure to continuously benchmark companys technology position and perspective against emerging technologies in the industry. Integrate learnings from external influences back into BRD.
• Ensure regulatory considerations are embedded early in development scaleup and technology decisions in partnership with Regulatory CMC colleagues.

BASIC QUALIFICATIONS

• B.S. or M.S. in Chemical Engineering Biochemical Engineering Biology or related field with a minimum of 12 years of relevant experience in biopharmaceutical development or manufacturing or Ph.D. with a minimum of 7 years of experience.
• Proven experience leading and managing direct reports
• Extensive experience/knowledge in process development pilotscale operations and portfolio enablement for biologics and advanced therapeutic modalities.
• Demonstrated leadership of complex multidisciplinary multisite organizations in a matrixed environment.
• Deep understanding of GLP/GMP principles regulatory guidance and CMC development expectations.
• Proven ability to make strategic decisions balancing technical rigor portfolio priorities and execution speed.

PREFERRED QUALIFICATIONS

• Experience leading portfolio planning governance or development operations for a complex biologics pipeline
• Experience advancing novel development or manufacturing technologies into clinical programs.
• Strong track record of crossfunctional influence across Research Manufacturing Regulatory and Digital organizations.
• Experience working with or transitioning programs to commercial manufacturing organizations.
• Experience managing external collaborations consortia or strategic partnerships related to process or technology innovation.

PHYSICAL/MENTAL REQUIREMENTS

• Ability to work effectively in office laboratory and pilotplant environments.
• Ability to evaluate and integrate complex technical operational and portfolio information to make strategic decisions.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• 15-20% travel required to other sites manufacturing facilities and partner locations; LT meetings etc.
• Periodic offhours support aligned with critical development or operational milestones.

ORGANIZATIONAL RELATIONSHIPS

• BRD Leadership Team
• Pharmaceutical Sciences technical lines (ARD PhRD)
• Portfolio strategy group (BPS)
• Biomedicine design (BMD)
• Pfizer Global Supply (PGS)
• Regulatory CMC
• Transformational Technology (TTDS)
• External technology partners and consortia

Supervision

• Role will require supervision of direct reports who maybe individual contributors and/or people responsibility will work with all BRD technical lines and SMEs in a matrix capacity

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:Hybrid

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

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.

Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.