• Developing late-stage DSP strategies for ongoing projects
• Defining the scope for late-stage DSP development activities with our CMOs and partners according to the latest industry standards and regulatory guidance
• Overseeing DSP activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification
• Preparing and reviewing technical documents, including development/tech transfer/process characterization reports and batch records
• Authoring and reviewing CMC regulatory submission documents
• Working closely with upstream processing, analytical validation, and characterization SMEs to develop and align late-stage development strategies
• Supporting the definition and refinement of required processes for DSP activities

• Thorough understanding and overview of downstream processes, with in-depth knowledge of downstream process characterization, risk assessment, and late-stage validation activities
• Preferred experience in designing and evaluating Do E experiments
• Preferred experience with virus clearance study design and evaluation
• Preferred experience in preparing and reviewing relevant filing documentation for regulatory market authorizations

• You are focused on achieving goals that are important for the team and the organization.
• You have a proactive approach and a desire to continuously develop and find innovative solutions.
• In addition, you are well-organized, and can plan, execute, and meet deadlines.
• You have the ability to work successfully in a fast-paced environment and with tight timelines.

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so