Principal Scientist, Biologics

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

📋 Description

• Deliver technical and analytical insights for early-stage biologics process development and manufacturing endeavors.

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

• Act as the Biologics lead for a designated therapeutic program.

• Direct development initiatives, encompassing process knowledge, technology transfer, analytical method transfer, design space, control strategy formulation, optimization, and qualification.

• Review and authorize SOPs, batch records, protocols, analytical methodologies, and development reports.

• Guarantee compliance through document generation, review and approval, quality investigations, corrective measures, and change control within a Quality system.

• Prepare and review source documentation and CMC content supporting IND, NDA, BLA, and comparable regulatory submissions.

• Facilitate collaborations with internal sites and external CMC partners, including capability evaluations, activity coordination, troubleshooting, risk assessments, and deliverable management.

• Provide mentorship to Senior Scientists and other Scientists on technical subjects and Telix values.

⛳️ Requirements

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

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

• Proven understanding and application of project management principles.

• Capability to operate effectively in cross-functional, virtual settings.

• Familiarity with various biologics technology areas, including analytical, purification, formulation, or bioconjugation.

• Proficient in communicating with cross-functional teams in formal environments and third-party meetings.

• Ability to manage workload independently while seeking feedback on complex matters.

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

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Remote work arrangement available.

• Hybrid work arrangements offered throughout the company.