Director, Manufacturing

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because

patient’s lives depend on it.

People are at the center of everything we do, and when it comes to our employees,

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because

patient’s lives depend on it.

People are at the center of everything we do, and when it comes to our employees,
we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories.
Director Manufacturing is responsible for defining and overseeing drug product manufacturing operations and ensuring sterile quality assurance and compliance to international standards at the Framingham, MA facility. The position will have the overall responsibility for monitoring and maintaining aseptic operations and systems consisting of technologies required for product formulation, filtration, vial filling and visual inspection. Reporting to the Senior Director of Manufacturing, the incumbent works closely with internal stakeholders (Operations, Engineering, Validation, Facilities, Quality Control and Quality Assurance) to ensure an aseptic program that adheres to contamination control strategy (CCS) and focuses on continuous improvement including providing support for GMP document management as part of day-to-day operations.

• This position is based in our Framingham location and typically has a 5-day on-site expectation.

• Aseptic operations at Framingham facility including process controls, ensuring environmental monitoring systems are adequately staged, best practices and training are established to ensure the site maintains best-in-class sterile product quality assurance.
• Leads risk management efforts for aseptic operational controls and defines and maintains the facility's cross-contamination and particulate control strategy
• Work effectively with department leads to manage day to day operations involving scheduling of activities and staff, planning, batch record creation, execution and revision for DP formulation and filling.
• Support investigations, CAPA closure and implementation, protocol execution and overall documentation to support sterile operations
• Partners with Facilities, Engineering and Validation groups to ensure effective standards are maintained for preventative maintenance and calibration of equipment/facilities to support sterile manufacturing.
• Support and/or lead deployment of new technology as part of continuous improvement to existing systems or build out of future manufacturing suites
• Ensure the hiring, development, and retention of staff including engagement of the Sterile Operations team to ensure commercial readiness in support of product launch
• Works externally in industry forums to establish relationships and help shape strategy and regulations for the requirements of aseptic operations using existing and new technologies
• Safety as highest priority – ensure staff comply with all Safety Standards, OSHA and environmental requirements at all times. Proactively evaluate safety issues and address. Encourage a working environment which…