Summary of Position:The Director, CMC Program Management will lead the operational and strategic execution of our Chemistry, Manufacturing, and Controls (CMC) portfolio. As a key member of the Global Pharmaceutical Development and Supply (GPDS) leadership team, this role will bridge the gap between high-level corporate strategy and technical execution. Operating in a lean, dynamic environment, this role will have a direct hand in shaping the CMC organization, managing end-to-end CMC planning, cross-functional integration, governance, risk management and lifecycle activities. The Director will play an important role in driving alignment, enabling effective decision-making, and advancing key CMC priorities across the portfolio.
Responsibilities:- Establish and oversee CMC strategy, planning and execution, ensuring portfolio-wide milestones align with corporate objectives and clinical/commercial timelines.
- Foster cross-functional integration between GDPS (CMC/Supply Chain), Regulatory Affairs, Quality Assurance, Commercial, Clinical, Alliance Management, etc. to eliminate silos and accelerate program velocity.
- Collaborate with Pharmaceutical Sciences and Technical Operations (PSTO) to manage external Vendors such as Contract Development Manufacturing Organizations (CDMOs) and Partners and hold them accountable for meeting agreed upon Quality, Regulatory and Manufacturing Supply goals for right first time-on time delivery.
- Serve as the operational voice for CMC, regularly presenting program status, milestones, and portfolio risk to the GPDS-Leadership Team, Executive Leadership Team (ELT), external partners, etc.
- Manage project-level risk with the Core Team by anticipating technical, regulatory, or macroeconomic threats to the supply chain and lead contingency planning. Promote and use Operation Excellence (OpEx) tools and best practices to build a high functioning team.
- Act as the escalation point for complex operational or manufacturing hurdles, driving, data-driven decisions to keep programs on track.
- Support financial forecasting, resource allocation, and partner with Global Supply and Logistics representatives (GSL) for long-range planning for drug substance and drug product supply.
- Communicate effectively and consistently verbally and in writing with all levels of staff, internally and externally.
- Perform other duties as assigned.
Experience & Education:- Bachelor of Science required; an advanced degree in chemistry, biology, or a related scientific or engineering discipline is preferred.
- 10 plus years of progressive industry experience, with a solid background in CMC and pharmaceutical development
- Significant experience working in an outsourced "virtual manufacturing" environment
- Experience with small molecules, biologic, and peptide drug products
Skills and Abilities:- Experience in development as well as late stage/product launch/commercial pharmaceutical projects with a strong track record of successful IND, NDA, and EMA filings
- Ability to interpret, communicate and apply cGMPs, global regulatory requirements, and industry best practices
- Excellent interpersonal and communication skills, with the ability to collaborate effectively across functions and levels of the organization.
- Willingness and ability to travel up to 20% for interactions with CDMOs and Partners for critical project activities or to represent IST in professional conferences
- Self-organizing, self-directed and highly motivated, with strong critical thinking and problem-solving skills
- Ability to initiate and manage external collaborations and engage key opinion leaders effectively
- Deep familiarity with global regulatory frameworks, including FDA, EMA, and ICH guidelines (specifically around 21 CFR and USP chapters).
- Excellent project management skills, with experience managing complex, cross-functional initiatives
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
