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VP, Chemistry, Manufacturing and Controls (CMC)

Company: Replimune Group, Inc.
Location: Framingham
Posted on: November 21, 2022

Job Description:

Overview

The Vice President of CMC is responsible for the leadership and management of Replimune's Manufacturing function at the Framingham site and the supporting global Process Development function. The role holder will oversee all aspects of drug substance and drug product development and scale up, technology transfer, clinical and commercial manufacturing. In addition to having ultimate accountability for day-to-day production, this role is responsible for conducting long-range, strategic planning for the production of a portfolio of products and ensuring that the Manufacturing and Process Development functions take required steps to enable production scale-up of our portfolio of assets in preparation for commercial production.The position reports to the SVP of Operations and is a key role within Replimune's senior leadership team.

This position will be based in Framingham, MA.

Responsibilities

Manufacturing:

* Provide the leadership, direction and management of the Operations functions reporting directly to him/her.
* Establish Manufacturing best practices, SOPs, operational timelines, resourcing and budget plans as required to ensure stable, reproducible, cost-effective processes, attuned for seamless commercial production
* Ensure that programs are in place to support the clinical development plans and global regulatory submission schedules. The strategy should include a commercial manufacturing strategy considering future clinical and commercial demand, financial investment, and supply risks
* Lead and establish management routines and performance metrics for manufacturing operations and COG reduction projects

Process Development:

* Lead, manage and continue to build the Process Development teams. Plan functional capability and capacity expansion as needed, support individual growth, and ensure the development of the teamsAs a member of the Operations leadership team, provide scientific, strategic, and operational input relating to all CMC aspects of pipeline programs, to deliver on corporate goals

Other Responsibilities:

* Responsible for achievement of Manufacturing Operations and CMC milestones, establishing objectives and appraisal of staff performance
* Technical lead for GMP manufacturing method development, process transfer, data analysis and reporting to ensure compliance with cGMP standards
* Establish KPI's and appropriate process / production monitoring to feed into the Quality Management Program
* Lead CMC team meetings and represent CMC on Core Strategy Teams to ensure alignment of CMC activities, priorities, resources to support company goals
* Develop disaster recovery and/or risk mitigation plans to ensure continuity of drug supply is maintained to support commercial and clinical trial requirements
* Provide technical expertise to Regulatory to support the efficient management of all CMC regulatory interactions and site inspectionsCMC lead for PAI readiness activities and ensure manufacturing facility and clean rooms remain in an inspection ready state
* Implementing and ensuring compliance with health and safety standards in the Manufacturing and Process Development areasProvide regular updates on Manufacturing Operations and CMC to the COO and other Replimune senior management

Qualifications

Educational requirements:

* MSc. or other post-graduate degree
* BSc. in an appropriate scientific field

Experience and skill requirements:

* Proven leadership in managing and motivating multi-disciplinary scientific and technical teams with strong awareness of optimizing the interaction and interface between, Commercial Operations, Engineering, Regulatory Affairs, Quality Assurance, Quality Control, Finance, Human Resources and Product Development.
* 15+ years of experience in relevant roles in a biotechnology or pharmaceutical industry environment
* 5+ years of experience of site or functional leadership in a GMP biopharma manufacturing environment
* 5+ years of experience of successful management of commercial GMP biopharma manufacturing strongly preferred
* Exceptional analytical skills complemented with a strong results orientation; able to find creative solutions even in the face of adversity
* Significant ability to influence others (senior management, peers, teams) in a cross-functional, global matrix
* Excellent verbal and written communication skills

Keywords: Replimune Group, Inc., Framingham , VP, Chemistry, Manufacturing and Controls (CMC), Executive , Framingham, Massachusetts

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