Associate Director, CMC Product Manager

Reporting to the head of Pharmaceutical Sciences, this position is cross-functionally focused throughout CMC, as well as with external partners and suppliers.  The role will manage internal and external CMC centric collaborations and drive IDRx CMC program progression throughout clinical development and commercial.   This candidate will be responsible for the coordination of planning and oversight of execution of all integrated activities related to the budgetary planning, development, manufacturing and packaging of small molecule solid oral drug formulations.  It will also manage the integration of CMC plans from pre-IND/IMPD through NDA/MAA, in support of IDRX clinical and commercial programs.  This is an excellent opportunity to join a small, nimble team and have substantial impact across the organization.

Key Responsibilities:

• Lead cross-functional teams to develop CMC integrated project plans to enable development strategies while supporting aggressive project timelines.
  • Maintain project plans and ensure communication of key CMC program milestones, and cross-functional interdependencies
• Lead internal team meetings, providing concise agendas, and effectively document, communicate, and drive accountability to actions and decisions for both internal and external working team members, as appropriate.
• Establish internal Product management infrastructure to navigate and manage all planning, development and manufacturing related documentation and tools.
• Perform scenario-planning, as requested, to demonstrate both strategic and financial impacts of path-forward options.
• Collaborate with internal Program manager to inform and align on cross-program interdependencies across the organization.
• Proactively work with key technical counterparts to manage multiple CROs and CMOs, during various phases of pharmaceutical development and manufacturing, regarding scope, timelines, and deliverables
• Lead and manage cross-functional review and approvals, as needed, for documentation such as protocols, master and executed batch records, validations (method and technical) and release packages.
• Drive Pharmaceutical Sciences budget planning by working closely with project technical leads to ensure budget alignment. Internally track project progression, facilitating early identification of areas where budget misalignment may occur from development, manufacturing and packaging perspectives.
• Proactively identify critical path/risks, to successful execution of program milestones and drive the development of mitigation strategies.
• Partner with technical experts, CMO, business development and Project Managers to schedule clinical manufacturing and development work, reviewing campaign proposals and change orders, submitting purchase orders, and tracking invoices.
• Collaborate with internal partners to monitor and plan appropriately for drug substance and drug product clinical and projected commercial needs, and program milestones, such as scale-up and/or technical transfer.
• Partner with CMC Regulatory, Quality and Technical leads to define and manage plans and timelines for the completion of all activities required to prepare and support CMC related sections for regulatory submissions.
• Coordinate and drive preparation of CMO business review meetings in collaboration with CMC counterparts.
• Facilitate Health Authority responses by driving information gathering, identifying source documentation, and managing response timelines to CMC related inquiries.
• Establish and maintain effective working relationships with key internal and external stakeholders.

Qualifications:

• BS or MS and 5-10 years of experience working in a biotech or pharmaceutical setting
• Experience managing people, and leading and fostering development on their team
• Skilled in establishing, maintaining, and managing relationships with CROs, CMOs and testing labs
• Comprehensive understanding of small molecule and solid oral dosage form development, regulatory and quality
• Experienced in late-stage program development including registration stability and process validation strategies
• Excellent communication skills, both written and verbal, keeping key stakeholders and management informed of status, issues and recommended solutions
• PMP certification is a plus
• Ability to travel 10%-15%, as required