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Vice President of Chemistry, Manufacturing, and Controls
2 months ago
Overview
The Vice President of Chemistry, Manufacturing, and Controls (CMC) plays a pivotal role in leading and managing the manufacturing operations at Replimune. This position is essential for overseeing the global Process Development function, ensuring that all aspects of drug substance and product development are executed effectively.
The role encompasses the responsibility for technology transfer, clinical and commercial manufacturing, and the strategic planning necessary for a diverse portfolio of products. The Vice President will ensure that the Manufacturing and Process Development teams are equipped to scale up production in preparation for commercial launch.
Key Responsibilities
Manufacturing Leadership:
Provide strategic direction and oversight for the Operations functions, ensuring the establishment of best practices, standard operating procedures (SOPs), and operational timelines. This includes:
- Developing resource allocation and budget plans to maintain cost-effective and reproducible processes.
- Implementing programs that align with clinical development plans and regulatory submission timelines.
- Formulating a commercial manufacturing strategy that considers future demand and supply chain risks.
- Leading the establishment of performance metrics and management routines for manufacturing operations.
Process Development:
Guide and expand the Process Development teams, ensuring:
- Functional capability and capacity are aligned with organizational needs.
- Individual team member growth is supported.
- Strategic input is provided on all CMC aspects of pipeline programs to meet corporate objectives.
Additional Responsibilities:
- Ensure the achievement of Manufacturing Operations and CMC milestones, including staff performance evaluations.
- Serve as the technical lead for GMP manufacturing method development and compliance with cGMP standards.
- Establish key performance indicators (KPIs) for production monitoring, contributing to the Quality Management Program.
- Lead CMC team meetings and represent CMC in Core Strategy Teams to align activities with company goals.
- Develop risk mitigation plans to maintain drug supply continuity for clinical trials and commercial needs.
- Provide technical expertise to support efficient management of CMC regulatory interactions and inspections.
Qualifications
Educational Background:
- MSc or other post-graduate degree in a relevant scientific field.
- BSc in an appropriate scientific discipline.
Experience and Skills:
- Proven track record in leading and motivating multi-disciplinary teams with a strong focus on collaboration across various functions including Commercial Operations, Engineering, Regulatory Affairs, and Quality Assurance.
- Over 15 years of experience in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership role within a GMP biopharma manufacturing environment.
- Exceptional analytical and problem-solving skills, with a strong results-oriented approach.
- Ability to influence and communicate effectively with senior management and cross-functional teams.
Replimune is committed to equal opportunity employment.
