Principal Scientist, Biologics

Telix Pharmaceuticals•Fishers, IN

50d

About The Position

This role provides technical and analytical expertise for late phase biologics process development and commercial manufacturing activities for 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 Principal Scientist, Biologics acts as the Biologics lead for a specific therapeutic program and should be comfortable communicating with cross-functional teams in formal settings and third-party meetings, be knowledgeable in several technical areas as well as their focus technology area (e.g. cell banking, cell culture, purification, formulation, or bioconjugation), and manage their own workload to complete assignments autonomously with some feedback from senior-level colleagues and/or their manager for more complicated topics.

Requirements

Science or engineering degree with minimum relevant experience as applicable: BS with 11+ years of experience, MS with 9+ years of experience, PhD with 8+ years of experience.
6+ years of experience in GMP, quality management system, and CMC compliance and regulation.
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.
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

Responsibilities

Leads development projects 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 produces clinical and/or commercial drug substance.
Authors, reviews, and approves external manufacturing operation documents such as 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, quality investigations, corrective actions, and change control within a Quality system.
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, and manages timely deliverables.
Experience in the commercialization of several programs from last cycle process development including optimization, process characterization, robustness, reproducibility, through process validation (process definition/ lock, PPQ, & CPV).
Mentors Senior Scientists and other level Scientists on both technical topics as well as Telix values.

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