Principal Scientist, Biologics

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide technical and analytical support for the development and manufacturing processes of early-phase biologics.

• Oversee projects spanning analytical, purification, formulation, and bioconjugation technology disciplines.

• Serve as the Biologics leader for a designated therapeutic program.

• Direct development initiatives that encompass process expertise, technology transfer, analytical method transfer, design space, control strategy formulation, optimization, and qualification.

• Review and authorize SOPs, batch records, protocols, analytical procedures, and development documentation.

• Ensure adherence to compliance through the creation, review, and approval of documents, quality investigations, corrective measures, and change control within a Quality system.

• Write and evaluate source documents and CMC content for IND, NDA, BLA, and other similar regulatory submissions.

• Lead collaborations with internal sites and external CMC partners, including capability evaluations, activity coordination, planning, troubleshooting, risk assessments, and management of deliverables.

• Mentor Senior Scientists and other team members on technical subjects and Telix values.

• Contribute to interdisciplinary collaborations aimed at developing and implementing clinical manufacturing.

⛳️ Requirements

• A degree in science or engineering with one of the following combinations of experience: BS with 11 years, MS with 9 years, or PhD with 8 years.

• At least 5 years of experience in GMP, quality management systems, and CMC compliance.

• Proven understanding and application of project management principles.

• Capability to function effectively within cross-functional, virtual teams.

• Technical expertise in various biologics technology areas, including analytical, purification, formulation, or bioconjugation.

• Proficient communication skills for engaging with cross-functional teams in formal settings and third-party meetings.

• Ability to manage workload independently, seeking feedback on complex topics as needed.

• Willingness to travel 10–25% for essential in-person meetings, partner site visits, and SME/technical person-in-plant interactions.

• Experience in supporting regulatory submissions such as IND, NDA, and BLA, utilizing comparability and risk-based strategies.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for professional growth and development.

• Option for remote work arrangements.