Senior Principal Scientist, Biologics

See Yourself at Telix

This role provides technical and analytical expertise for biologics process development and manufacturing activities for commercialization of multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) ensuring manufacturing processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing projects in multiple technological areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) at external CDMO partners, as well as contributing to internal cross-functional collaborations to develop and execute clinical and commercial manufacturing.

The Senior Principal Scientist, Biologics is a subject matter expert who acts as the Biologics lead for one or more therapeutic programs and should be comfortable communicating with cross-functional teams including governance forums with senior leadership team members in formal settings and third-party meetings, be an expert in one or more technical areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation), and manage their own workload to complete assignments autonomously with occasional feedback from senior-level colleagues and/or their line manager for more complicated topics.

Key Accountabilities:

• Oversee process development and commercialization for multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) ensuring the appropriate process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or validation to produce clinical and/or commercial drug substance.
• Oversee external manufacturing operation projects to deliver SOPs, batch records, protocols, and reports for multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) to produce clinical and/or commercial drug substance.
• Ensures appropriate compliance of multiple technology areas (e.g. cell banking, cell culture, purification, formulation, or bioconjugation) through document creation/review/approval, corrective actions, and change control within a Quality system including complex quality investigations with advanced root cause analyses.
• Authors and/or reviews source documents and CMC content related to several technology areas (e.g. cell culture, purification, formulation, or bioconjugation) to support IND, NDA, BLA and similar regulatory agency applications, especially in areas requiring more sophisticated acumen such as comparability and risk-based approach justifications.
• Leads collaborations with external partners such as CDMOs to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, guide complicated exceptions for TT and/or validation protocols, and manages timely deliverables.
• Mentors other level Scientists on both technical topics as well as Telix values.

Education and Experience:

• Science or engineering degree with minimum relevant experience as applicable: BS with 14+ years of experience, MS with 12+ years of experience or PhD with 11+ years of experience.
• 14+ years of experience in GMP, quality management system, and CMC compliance and regulation.
• Life-cycle experience in Phase III products as well as Commercialization of processes.
• Experience in leading BLA-enabling studies and data packages
• Demonstrated understanding and application of project management principles and tools.
• Ability to work in cross-functional, virtual teams.
• Travel expectation: 10 - 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant assignments.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills