CMC, Project Management Coordinator
Who we are:
Constellation Pharmaceuticals is a pioneering epigenetics company, focused on the discovery and development of novel, small molecules targeting chromatin regulatory proteins in tumor and immune cells for therapeutic applications in oncology. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.
How you will spend your day:
As the holder of a newly created position in CMC group, the CMC, Project Management Coordinator will act as the operational liaison, mainly responsible for oversight and implementation of key partnerships between the CMC and cross-functional teams internally and externally. The CMC, Project Management Coordinator will represent CMC development teams with a predominantly operational focus, ensure alignment of CMC operational plans and budget with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and internal functions and external vendors.
- Operationally coordinate the CMC development and manufacturing activities for early and late phase drug development candidates
- Assist internal project business lead in managing the project’s budget. This includes monitoring invoices, monthly monitoring of budget, verify receipt and payments, coordinate monitoring of contractual agreements
- Facilitate the establishment of integrated CMC operational plans and oversee their execution
- Provide project management and operational oversight of routine vendor services, managing contracts, timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; services covered include drug substance manufacturing, drug product manufacturing, packaging and analytical testing services
- Facilitate process improvement, identifying and recommending improvements in the operational efficiency of the CMC team
- Generate periodic updates to keep business team apprised of operational state. These updates could be verbal or standard/ad-hoc reports
- Track and organize development and cGMP documentation generated at CRO and CDMO’s and assist with regulatory filing activities by providing applicable documentation
- Liaise with legal, finance, and accounting to manage existing PO’s and support initiating new collaborations
- You will have knowledge and understanding of all aspects of administrative and technical operational support that is needed on each program
- Coordinate with the alliance manager to help shepherd contracts and statements of work through pricing and approval process
- Support for due diligence/business development opportunity evaluations as required
Key things about you:
- You will have a BS or MS in Science, Engineering or another technical field under your belt
- You will have developed at least 2-3 years’ experience in a functional area, such as Operations, Manufacturing, Engineering, Pharmaceutical Development
- You will have in-depth understanding of the drug development process and essential activities across all key functional areas
- You are a process-minded problem solver with an ability to be collaborative across multiple functional areas
- You will have experience managing multiple programs simultaneously
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.