Principal Scientist, Biologics at AMER in USA- Remote

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This role provides technical and analytical expertise for early phase biologics process development and manufacturing activities for multiple technology areas (e.g. analytical, purification, formulation, and 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 technology areas (e.g. analytical, purification, formulation, or bioconjugation) at internal sites and external CMC partners, as well as contributing to internal cross-functional collaborations to develop and execute clinical 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. analytical, purification, formulation, or bioconjugation), and manage their own workload to complete assignments autonomously with some feedback from senior-level colleagues, matrix team members,

and/or their manager for more complicated topics.

Key Accountabilities:

• Leads development projects for multiple technology areas (e.g. analytical, purification, formulation, or bioconjugation) ensuring the appropriate process knowledge, technology transfer, analytical method transfer, design space and/or control strategy definition, optimization, and/or qualification to produces clinical drug substance intermediates.
• Supports review and approval of manufacturing operation documents such as SOPs, batch records, protocols, analytical procedures, etc., and development reports for multiple technology areas (e.g. analytical, purification, formulation, or bioconjugation) to produce clinical drug substance intermediates.
• Ensures appropriate compliance of multiple technology areas (e.g. analytical, 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. analytical, 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
• Leads collaborations with internal sites and external CMC partners to develop selection criteria, assess capabilities, coordinate activities, plan process technology /analytical method activities, troubleshoot and analyze operational performance, conduct risk assessments, and manage timely deliverables.

Mentors Senior Scientists and 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 11 years of experience, MS with 9 years of experience, PhD with 8 years of experience.
• Minimum 5 years of experience in GMP, quality management system, and CMC compliance and
• Demonstrated understanding and application of project management principles and
• Ability to work in cross-functional, virtual
• Travel expectation: 10 – 25% for key in-person meetings, partner site visits, and SME/technical person-in-plant

Key Capabilities:

• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills