Overview:
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. Associate 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.
Responsibilities:
Primary responsibilities include:
- 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 encourages input from all personnel.
Qualifications:
Educational and experience requirements:
- BA in Engineering/Biology/Chemistry/Biochemistry/Microbiology or other related science with minimum 10 years of work experience or Master’s degree with 8 years of work experience.
- Minimum 6 years of experience in sterile product development and operations/aseptic facility controls or relevant cGMP environment.
- Experience leading teams and/or staff in a GMP-regulated environment is preferred.
- Technical experience in sterile product development, control implementation (e.g. CCS) and visual inspection is required.
- Strong problem-solving skills; attention to detail and track record of excellent decision making and issue resolution.
- Demonstrated ability to work in cross-functional teams and across the business, persuasive and effective negotiation.
- Experience in written and oral communication with health authorities (e.g. FDA, EMA).
Location:
This position is based in our Framingham location and typically has a 5-day on-site expectation.
#J-18808-Ljbffr
