Senior Principal Scientist, Biologics - Translational Medicine

Telix Pharmaceuticals•Fishers, IN

45d

About The Position

This role provides technical and analytical expertise for translational to early phase biologics process development and manufacturing activities ensuring developability and manufacturability assessments and drug substance intermediates are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for managing projects in multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) at external partners, as well as contributing to internal cross-functional collaborations to develop and support future preclinical activities, process development, and/or clinical manufacturing. The Senior Principal Scientist, Biologics - Translational Medicine 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, bioprocess/bioconjugation, analytical, formulation, and/or other), and manage their own workload to complete assignments autonomously with occasional 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 14 years of experience, MS with 12 years of experience, PhD with 11 years of experience.
Minimum 10 years of experience in translational to early phase 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

Oversee development projects for multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) ensuring the appropriate developability and manufacturability assessments to enable future process knowledge, technology transfer, analytical method transfer, design space definition, to produce preclinical and/or clinical drug substance intermediates.
Oversee external manufacturing projects to deliver SOPs, batch records, protocols, and reports for multiple technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, and/or other) to produce preclinical and/or clinical drug substance intermediates which may include monoclonal antibody or other molecule type bulk, bioconjugate bulk, and vial components of such.
Authors and/or reviews source documents and CMC content related to several technology areas (e.g. cell banking, bioprocess/bioconjugation, analytical, formulation, or other) to support early IB, IMPD, and similar regulatory agency applications, especially in areas requiring more sophisticated acumen such as risk-based approach justifications. Ensures appropriate document curation, storage, and compliance through document creation/review/approval within a Quality system.
Leads collaborations with external partners to develop selection criteria, assess capabilities, coordinate activities, plan process technology transfer/analytical method transfer, troubleshoot and analyze operational performance, conduct risk assessments, and manage timely deliverables.
Mentors other level Scientists on both technical topics as well as Telix values.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume