Technical Operations CMC Project Manager
We are seeking a CMC Project Manager to help drive the overall success of our development programs within Technical Operations. The individual will work collaboratively with the Technical Operations Technical Leads and their program teams to plan, track and report the diverse activities managed by Technical Operations. 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 preclinical and early 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 cell and gene therapy programs. We are seeking someone with a sense of urgency for developing important new medicines for devastating diseases and who is interested in forging new and uncharted paths to patients using the exciting CRISPR technology.
- Partner closely with the Technical Operations Technical Leads to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project.
- Track and monitor key milestones and decision points to drive delivery of project objectives.
- Coordinate input, maintenance and revision of the project plans for assigned projects, with escalation of unforeseen changes in resource demand, risks, gaps and challenges within a timely manner to Technical Lead
- Facilitate team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
- Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects, as well as ensure team members are aware of integrated project timelines
- Organize and maintain team communications including: meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies
- Ensure the development and use of key project management tools, metrics and team meeting logistics and documentation, by the Technical Operations Technical Lead and all team members, to enhance project delivery and information dissemination to the broader program team
- Develop and maintain integrated portfolio resources and budgets across all Technical Operations sub-functions for assigned projects
- Facilitate short-term and Long-Range Planning activities for CMC/Technical Operations for assigned projects
- Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
- Bachelor’s degree in sciences or related field
- 5+ years of relevant biopharmaceutical industry experience with 3+ 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
- Clear and succinct verbal and written communication skills
- Strong analytical, problem solving and critical thinking skills
- 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
- Advanced degree (MS, PhD or MBA)
- Previous experience in analytical development, process development and/or manufacturing of biologics/cell & gene therapy
- Prior background in CMC project management at a biotech/pharma company focused on biologics/cell & gene therapy
- PMP certification
- Collaborative – Openness. One Team.
- Undaunted – Fearless, Can-do attitude.
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
Crispr Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.