Senior Director / Director, CMC Lead

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In this role the selected candidate will lead a team of MS&T professionals by providing strategic and operational leadership for the CMC execution and lifecycle management radiopharmaceutical drug products. You will be the primary interface between Manufacturing Operations, Quality Assurance, Regulatory and the Program Team. You will ensuring scientific excellence, robust lifecycle stewardship, and optimal resource utilization across competing priorities. You will develop, build, and motivate a team of experts responsible for CMC content of late stage to commercial radiopharmaceutical drug substance, API, and drug product. You will also provide strong direction in prioritization of life cycle management and technology excellence activities to optimize resource utilization given competing requirements for key development within the radiopharmaceutical pipeline.

Location: This role will be based in Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities:

• Lead the MS&T team to support effective product development activities with Technical Operations organization
• Lead the MS&T team to develop a robust life cycle management for Convergent’s late stage assets
• Represent CMC matters within Convergent’s Program Teams.
• Provide strong leadership for initiatives which are complex or span across multiple products or lifecycle stages.
• Ability to lead the MS&T team to effectively resolve issues relating to CMC matters
• Ability to work across all Technical Operations functions, including external manufacturing sites, Manufacturing operations, Quality Operations, and Regulatory to define lifecycle road maps and cross functional impacts.
• Provide recommendations to have a direct impact on program’s outcome.
• Has a deep and broad understanding of biologics/ radiopharmaceutical drug product development, manufacturing, the regulatory environment, life cycle management and trends in innovation
• Work closely with the PMs to drive to the success of the MS&T team.

Requirements:

• A bachelor degree in engineering or life sciences.
• Minimum 12+ years experience in biologics development, manufacturing, and launch.
• Experience defining the strategy and roadmap for complex, cross-functional initiatives.
• Strategic thinking, finding innovative ways to serve patients and build reputation and trust.
• Creating the environment that inspires and enables people.
• Focusing on the few priorities and provide superior results.
• Elevating capabilities for now and the future.
• Capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
• This is a Hybrid role, in office 2 to 3 days a week
• At this time we are only considering Boston, MA based candidates.

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.