Director, Biologics

AMER•Fishers, IN

About The Position

The role of Director, Biologics will oversee process development and clinical production of radiolabeled monoclonal antibodies and conjugates within Telix’s Global Operations organization. This leadership position is responsible for guiding late-phase development and commercialization strategy, managing a team of bioprocess and bioconjugation scientists and engineers, and ensuring readiness for scale-up and manufacturing. The role will play a critical part in advancing Telix’s biologics programs through clinical development and toward commercial launch.

Requirements

Bachelor’s degree plus 17 years of experience, or Masters degree or PhD plus 10 years of experience, in bioprocess development, validation, and commercialization.
5+ years in leadership, ideally managing global teams and external partners (e.g., CDMOs)
10 years of experience in GMP, quality management system, and CMC compliance and regulation.
Strong written and verbal communication skills are required.
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

Nice To Haves

Experience working with radiolabeled antibodies is preferred.
Experience of contributing to regulatory filings is preferred.

Responsibilities

Provide direction for late phase process development, validation, and commercialization strategies including timeline, resource plans, and key evaluations.
Oversee the process development and validation activities, ensuring alignment with corporate objectives.
Lead and motivate a team of bioprocess and bioconjugation scientists and engineers, fostering a culture of collaboration, compliance, and technical excellence.
Demonstrate Telix values, leadership competencies, and industry methodologies, platforms, and best practices.
Mentor team members on evaluation and execution for activities such as late-stage process development, process characterization, technology transfer including analytical methods, risk assessments, and validation.
Manage relationships with internal and external partners including CDMOs and consultants, ensuring project requirements and external partner capabilities align to support production, optimization, and scale-up.
Responsible for scoping, negotiation, budgeting and contracting of external activities.
Guide team members’ support of clinical manufacturing activities such as production forecasts & planning, NPI & GMP readiness, and batch release.
Ensure Biologics deliverables comply with GMP requirements across multiple regions.
Uphold GxP standards, especially documentation within our internal QMS and within external partner GMP manufacturing QMS including technical input to capture investigations, root cause analysis, and other quality events.
Engage directly in cross-functional program matrix teams by providing options analysis and program timeline input.
Support & mentor team members ensuring execution to plan and timely notification of issues and risks.
Contribute to the creation of process development, technology transfer, and validation plans within a CMC stage gate framework.
Ensure appropriate source documentation to support regulatory filings, as well as review Module 3 CMC content for IND/IMPD, BLA, & MAA, and other regulatory documents.
Contribute key inputs to regulatory strategy for late-stage CMC topics, including areas requiring more sophisticated acumen such as comparability and risk-based justifications.
Participate in efforts for optimization of internal business processes including input on key CMC deliverables.
Generate presentations, storyboards, and written documentation related to complex technical content for internal and external stakeholders.