CMC Program Lead

Company: Rallybio, LLC
Functional Role:CMC Program Lead
Proposed Start Date: June 2021
Location: New Haven, CT
Manager: CMC Lead

Rallybio is a privately held development-stage biotechnology company incorporated in January 2018. The Company has raised more than $180 million in financing with the ambition to transform the lives of patients with devastating diseases and has a pipeline of assets in development.

Rallybio is seeking an experienced individual who will be responsible for all aspect of CMC development for multiple development programs from preclinical to late phase and commercial. Responsibilities include managing external CDMO and CRO resources for the process development, manufacturing and supply chain activities for Rallybio programs. Additional responsibilities include the support of quality and regulatory strategies appropriate for the phase of development, and for partnering in the development and implementation of a QMS consistent with GMPs and regulatory guidelines. This position represents a great opportunity to join a growing CMC team and help us shape the future state for R&D at Rallybio.

Responsibilities

  • Lead the development of the CMC program strategy for multiple products in alignment with the overall program strategy
  • Assume overall responsibility for the technical and operational management of CMC activities, including GMP manufacturing and testing operations for drug substance and drug product materials supporting clinical studies
  • Identify, and escalate key issues, risks and mitigation plans
  • Manage the CMC budget, including forecasting/tracking facility and Manufacturing costs
  • CMO Identification and selection for cGMP manufacturing and clinical trial materials supply
  • Work closely with QA/QC partners to ensure quality in manufactured materials and manufacturing processes
  • Author regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter expert in regulatory interactions
  • Participate in multi-functional project teams
  • Drive decision making and the associated deliverables for all CMC and CMC related activities
  • Build and maintain strong relationships with internal and external stakeholders
  • Support business development assessments as needed
  • Some domestic and international travel may be required

Skills, Experience and Qualifications

  • A minimum of a B.S. in biological sciences or a related scientific field with an advanced degree (M.S., Ph.D. or M.B.A.) preferred, and over ten years of relevant industry experience covering both drug substance and drug product operations
  • Demonstrated experience supporting process/analytical development and cGMP manufacturing operations at third-party manufacturers
  • Strong leadership skills, including a demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization
  • An entrepreneurial approach to develop new, innovative ideas that will drive growth within Rallybio
  • Solid understanding of drug development
  • Strong analytical, problem-solving, and critical thinking skills, including combining attention to detail with a big picture perspective
  • Comfortable with the rapid changes inherent in a startup environment
  • Experience navigating both success and failure of programs with gravitas
  • Knowledge/experience with multiple drug modalities is an advantage, experience with biologics is a must
  • Team-oriented, motivated, highly-organized, detail-oriented, diplomatic, and calm under pressure, with the ability to thrive in an entrepreneurial and multidisciplinary environment
  • Prior experience as a liaison with corporate partners preferred
  • Active listener and clear communicator who demonstrates a supportive attitude that encourages collaboration cross functionally and is able to effectively and proactively communicates essential information with all levels of the organization
  • Ability to work independently in a fast-paced team environment and willing to assist other team members to achieve team goals and objectives
  • Opportunistic mind set focused on continuous process improvements

Qualified candidates should submit their resume to HR@rallybio.com.  This role is open for direct candidate submission. Resumes from recruiters will not be accepted at this time. Rallybio does not accept unsolicited headhunter and agency resumes. Rallybio will not pay any third-party agency or company that does not have a signed agreement with Rallybio.

Rallybio is proud to be an Equal Employment Opportunity and Affirmative Action employer.  We celebrate diversity and are committed to creating an inclusive environment for all employees.  All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs.  We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.