Versanis Bio, an Aditum Bio portfolio company, is a privately held, clinical-stage biopharmaceutical company bringing transformational treatments to people living with cardiometabolic disease. Bimagrumab is the lead Versanis Bio program and currently in late phase 2 clinical development, with a goal of helping overweight and obese adults achieve and maintain a healthy body composition.
Versanis Bio fosters an innovative and collaborative environment focused on employee personal growth and accountability. We are seeking self-motivated employee with a passion for improving lives of patients and their families.
The Senior Manager / Associate Director of CMC will be responsible for providing CMC support for our lead compound bimagrumab, a fully human monoclonal antibody that blocks ligand binding to activin type II receptors. The focus will be to work collaboratively with all development functions (Clinical, Regulatory, Quality) and key consultants to ensure effective coordination and implementation of all CMC and supply chain activities. This person will take the lead in evaluating and selecting CMOs and finalizing vendor Statement of Work (SOW) and related contractual agreements. Additional responsibilities include identifying necessary Standard Operating Procedures (SOPs), Best Practices, and tools to efficiently report progress and for compliance purposes.
This is a hybrid role that can be based in either Boston or New York City.
- Provide technical CMC expertise while managing all manufacturing and supply chain operations and oversee of CDMOs including ensuring action items are tracked, followed up, and completed on time.
- Lead CDMO evaluation and recommendation within the context of program strategy.
- Actively manage CDMO partnerships and to identify risk-mitigation and optimization actions.
- Monitor CMC related invoices and payments and forecast and maintain CMC operating budgets.
- Work with Regulatory, Quality and Clinical project leads and provide stakeholders and senior management the CMC activity and strategy update on a regular basis.
- Work with the Regulatory CMC team and cross-functional groups to establish, facilitate implementation, and maintain SOPs, and other controlled documents.
- Support and maintain the CMC module documents to create submission-ready documents.
- Manage the CMC SharePoint sites and support technology transfer with CDMOs and partners.
- Minimum of bachelor’s degree in a relevant scientific field, MS or PhD degree preferred.
- 5 – 10 years of overall combined experience in an industry CMC leadership role, preferably in a Therapeutic, Pharmaceutical, Biotechnology or start-up environment.
- Expert knowledge of cGMP manufacturing process and the management process for CDMOs. Drug-device combination experience strongly preferred but not essential.
- Experience in establishing and successfully implementing CMC internal controls.
- Demonstrated ability to think strategically about the role of CMC and supply chain in supporting the company’s strategy, as well as the ability to work cross functionally.
- Understanding and experience with analytical method development and establishment preferred
- Experience defining stability plans and product shelf-life a plus
- Ability to influence senior stakeholders and drive decisive action on CMC operational and process issues.
- Ability to work independently and take initiative with minimal daily direction to accomplish objectives and deadlines.
- Strong, analytical communication (verbal and written), project management, and business partnering skills.
- Ability to determine what resources to call upon to solve potential problems at hand.
We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.