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 Will You Spend Your Day?
As a key member of the CMC group, the Senior Manager, Chemical Development will manage development and manufacturing activities. The position will focus on oversight and implementation of key partnerships with external CROs and CMOs. The successful candidate will have a background in organic chemistry/process development with an ability to understand and communicate with functional groups externally, and key stakeholders internally. This is a position that puts an individual at the apex of managing external relationships with drug development vendors including but not limited to RSM, DS, and DP manufacturing sites. You will manage strategic supplier relationships from early-stage development through to Phase 3 supply for Constellation’s clinical candidates. In this role, you will be leading cross-functional governance teams with responsibility for the execution of development activities and clinical supply, GMP, quality, and compliance standards. In working closely with the QA lead, you will be accountable for monitoring quality, compliance, and regulatory aspects.
- Primary interface with CRO and CDMO partners to design and implement synthetic pathway, drive process development, related analytical control strategies and cGMP manufacturing campaigns
- Ensure successful technology transfers, scale-up, and validation for drug substance manufacture
- Leverage subject matter expertise to review batch records, process data, support quality event investigations and resolve technical issues
- Assist in developing and reviewing CMC regulatory submissions
- Be the go-to person internally for external manufacturing/alliance related matters
- Oversee joint meetings with CROs and CMOs including scheduling, agendas, documenting minutes, identifying key issues, ensuring deliverables, and communicating decisions.
- Act as point-person for all internal & external communications on assigned manufacturing Identify and drive resolution of issues as they arise
- Act as an internal consultant to partner with CMC, Non-Clinical, Clinical and Regulatory groups to track alliance budgets and milestones and communicate progress to finance function
- Regularly communicate with the PM/counterpart from the manufacturing site and other key stakeholders as needed, including ad hoc communications/events that require cross-functional communication
- Participate in the review of new partner contract negotiations as appropriate and provide input into execution terms of the contract, such as governance structures and processes, set up kick-off process
- Prepare RFPs and scope of work and/or negotiate timelines and cost with the contracting organization
- Manage project timelines, milestones, key requirements, and financial agreements
- Build expertise and a strong relationship with the contract organization, understand the company organization/leadership, strategies, financials, priorities, ; become Constellation’s “internal expert” on the contract organization
- Manage budgets and financial performance to ensure financial targets are achieved
Key Things About You:
- You will either offer a Ph.D. in chemistry with 5+ years of industry experience OR BS/MS with 10+ years of industry experience in the field of small molecule drug development
- You will have developed extensive experience interfacing with and providing scientific guidance to CRO and CDMO partners
- You will have expertise in synthetic process chemistry and related analytics; exposure to formulation development requirements is a plus
- Understanding GMP Manufacturing processes is a plus
- Prior experience in the life sciences, with specific experience in creating and executing on alliance management best practices
- 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
- You are excited to travel both internationally and domestically and flexible to accommodate teleconferences outside of regular working hours