Senior Principal Scientist, Analytical Development

ROLE SUMMARY

As a Senior Principal Scientist in Chemical Process and Analytical Development (CPAD) you will provide technical leadership to a team of process and analytical chemists engaged in the development and characterization of processes for our growing Drug-Linker portfolio.  You will drive product characterization and development of robust control strategies by leveraging state-of-the-art technologies in chromatography and spectrometry.  You will spearhead the advancement of Pfizer’s Oncology portfolio through personal laboratory effort as well as oversee external resources through technology transfer and campaign execution at Contract Development and Manufacturing Organizations (CDMO).  You will serve as a technical and strategic leader for early and late-phase programs while mentoring junior staff members in a supportive and inclusive work environment. You will propose technical and strategic solutions to Management and represent analytical development in cross-functional teams requiring excellent communication skills. Finally, you will be expected to establish an external presence as technical leader in the field by authoring journal articles and presenting at leading external scientific meetings.

ROLE RESPONSIBILITIES

• Lead Analytical method development activities for multiple Drug-Linker programs in across all development phases, including supporting manufacturing process development, developing, validating and transferring analytical methods and designing stability studies.

• Contribute to and potentially lead multidisciplinary teams at the sub-function level, developing plans and managing resources for development projects.

• Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate.

• Evaluate new approaches, instrumentation or analytical technologies.

• Develop appropriate Drug-Linker analytical control strategies that align with program and regulatory expectations.

• Encourage effective collaboration with project team members, presenting data, critically reviewing results, and solving technical challenges during development.

• Support off-site analytical technology transfers, method validation, manufacturing support, and interactions with CDMO’s.

• Author relevant sections of the quality modules of regulatory submissions.

QUALIFICATIONS

• PhD with at least 8+ years of experience or MS with at least 10+ years of experience in pharmaceutical development.

• Effective leadership skills and the ability to enhance collaboration within a cross-functional team.

• Exceptional written communication skills, including the ability to maintain a precise scientific notebook and draft clear, concise reports, publications, and related documents.

• Deep experience in a wide range of analytical methodologies such as High-Pressure Liquid Chromatography, Ultra High-Pressure Liquid Chromatography, Gas Chromatography, and Mass Spectrometry.

• Demonstrated expertise in troubleshooting instruments and navigating various software and information systems, including electronic lab notebooks, OpenLab, and Laboratory Information Management Systems (LIMS).

• Proven track record of effective people management skills, either through direct line supervision or leading project teams.

• Ability to work independently and make decisions in ambiguous situations.

PREFERRED QUALIFICATIONS

• Experience with Drug-Linkers for Antibody Drug Conjugates (ADCs) or other targeted mixed-modality therapeutics. 

• Experience in mentoring scientific staff, both directly and in a matrix environment. 

• Experience with technology transfer activities and CRO/CDMO resource management. 

• Experienced in authoring regulatory documents such as Investigational New Drug application (IND’s) and New Drug Applications (NDA’s).

• Experience in preparative chromatography is a plus.

  
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.
 

PHYSICAL/MENTAL REQUIREMENTS

This is a lab-based position which requires adherence to safe work practices and procedures such as dawning appropriate PPE and working with engineering controls such as isolators and laminar flow hoods.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional domestic and internat