CMC Project Manager (Remote)

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.

To learn more about our story and company culture, please visit us at https://roivant.com/

Position Summary

We are seeking a CMC Project Manager to help drive the overall success of our development programs within CMC. The individual will work collaboratively with the CMC Leads and their program teams to plan, track and report the diverse activities managed by CMC. This includes, but is not limited to, process development, analytical development, technical transfer, regulatory documentation, clinical manufacturing, commercial planning, project strategy and vendor management.

This is an exciting and visible role for a highly qualified and motivated individual. The successful candidate will be a confident project manager, with attention to detail and significant prior success in early and late clinical stage project management in the biotechnology industry. The ideal candidate will be detail driven and have a proven track record in managing and driving project success within CMC in the pharma/biotech industry, preferably with experience in both small and large molecule programs.

Responsibilities

• Coordinate the design and execution of cross-functional CMC project plans for early clinical development to commercial readiness.
• Track and monitor key milestones and decision points to drive delivery of projects in accordance with corporate objectives.
• Proactively identify CMC critical path, risks and impediments to successful development and drive the identification and development of solutions to mitigate these risks.
• Prepare summary information on CMC project progress, timeline updates and risk assessment for integration into development plans and overall program timelines; periodic presentations to program oversight committees.
• Facilitate team meetings and ensure that clear agendas are set, and actions and decisions are documented, communicated and committed to, enabling timeline achievement.
• Build strong working relationships across departments, with key stakeholders to ensure transparency and to facilitate communication.
• Establish project management best practices and assist in the implementation of infrastructure necessary for successful project management such as the preparation of SOPs relating to written processes and procedures and the establishment of electronic document standards.
• Independently develop the project plan based on work breakdown structure.
• Serve as the primary point of contact for CMC project management activities internally and externally.
• Facilitate short-term and Long-Range Planning activities for CMC/Technical Operations for assigned projects
• Support discussions regarding clinical and commercial supply agreements. Support sourcing process as needed.
• Assess CMC project performance using appropriate tools and techniques and identify any variances to the approved CMC project plan.

Qualifications

• S. degree in life sciences, chemistry, engineering or equivalent; PhD, MS or MBA preferred
• 5-7+ years of relevant biopharmaceutical industry experience with 5+ years of Project Management experience
• Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively
• Experience working with CMC Teams and managing relationships with CMC vendors is strongly preferred
• Pre-clinical and clinical  stage CMC development experience is required
• Clear and succinct verbal and written communication skills
• Strong analytical, problem solving and critical thinking skills
• Action-oriented with strong follow through
• Outstanding project management skills, responsiveness to issues, and demonstrated passion for creating new medicines
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced, small company environment with changing priorities while maintaining attention to detail
• Proficiency in MS Office suite, including MS Project

Roivant Sciences provides 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.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!