Senior Director / Director, CMC Lead

Convergent Therapeutics, Inc.; Boston (MA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Convergent Therapeutics, Inc. is looking for a leader for their MS&T team in Boston, MA. This hybrid role involves supporting product development and lifecycle management for late-stage assets, requiring a bachelor's degree in engineering or life sciences and over 12 years of experience in biologics development.

The successful candidate will lead complex initiatives, work closely with project managers, and drive the success of the team while inspiring and enabling people.

Qualifications

• Minimum 12+ years experience in biologics development, manufacturing, and launch.
• Experience defining the strategy and roadmap for complex initiatives.
• Capable of analyzing and solving complex problems enhances project success.

Responsibilities

• Lead the MS&T team to support effective product development.
• Develop a robust life cycle management for late stage assets.
• Work closely with PMs to drive success of the MS&T team.

Skills

Leadership

Biologics development

Strategic thinking

Project management

Education

Bachelor's degree in engineering or life sciences

Job description

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.

Location

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.