See Yourself at Telix

This role provides technical expertise for process development and manufacturing activities related to aseptic fill/finish, lyophilization, and secondary packaging, ensuring processes are sufficiently developed to meet program objectives, safety standards, regulatory expectations, and quality compliance. This role is responsible for serving as the subject matter expert on internal cross-functional teams and with external CDMO partners, collaborating with all stakeholders to develop and execute clinical and commercial manufacturing. In addition, this role utilizes their technical expertise and industry experience to lead company/department continuous improvement projects, capital projects, and strategic program decisions

Key Accountabilities:

• Subject matter expert of pharmaceutical development and manufacturing activities related to aseptic fill/finish, lyophilization, and secondary packaging. Leads company/department continuous improvement projects, capital projects, and strategic program decisions. 

• Analyze production processes, schedules, workflows, control strategies, and other complex datasets. Identify and communicate gaps, risks, and inefficiencies. Drive implementation of process improvements and risk mitigations. Lead manufacturing investigations and root cause analysis. 

• Oversee technical collaborations with multiple contract development/manufacturing organizations (CDMOs) to provide technical support and achieve key project milestones. Lead audits, new vendor evaluations/selections, quarter business reviews, and other vendor-related initiatives. 

• Author and review external manufacturing operation documents such as SOPs, batch records, protocols, and reports to produce clinical and/or commercial products. 

• Manage, author and support the submission of CMC sections in IND, NDA, BLA, and related regulatory filings. 

• Ensure appropriate compliance through document creation/review/approval, quality investigations, corrective actions, and change control within a Quality system.

Education and Experience: 

• Science or engineering degree with 10+ years of relevant operational pharmaceutical experience across a breadth of functions including but not limited to manufacturing operations, bioprocessing technology, validation, and engineering 

• Experience in MS Office suite applications (e.g., Excel, Word, Project) 

• Experience working with cross-functional teams, external partners and CDMOs 

• Experience in authoring and reviewing challenging technical documents, including but not limited to protocols, reports, CMC modules, and filing response 

• Subject matter expert in aseptic fill/finish, visual inspection, lyophilization, and secondary packaging, and knowledgeable in other key functional areas within pharmaceutical operations 

• Very knowledgeable in pharmaceutical and process development.

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