Director, Manufacturing

About the role

Replimune is a fast-paced, growing innovative company bringing online 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. The Director of Manufacturing is responsible for defining and overseeing drug product manufacturing operations, ensuring sterile quality assurance and compliance to international standards at the Framingham, MA facility.

The position will have overall responsibility for monitoring and maintaining aseptic operations and systems, including 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 the contamination control strategy (CCS) and focuses on continuous improvement. This position is based in Framingham and typically requires a 5-day on-site presence.

Responsibilities

• Aseptic operations at the Framingham facility, including process controls, ensuring environmental monitoring systems are adequately staged, and establishing best practices and training to maintain 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.
• Works 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.
• Supports 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.
• Supports and/or leads deployment of new technology as part of continuous improvement to existing systems or build-out of future manufacturing suites.
• Ensures 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.
• Prioritizes safety—ensures staff comply with all Safety Standards, OSHA, and environmental requirements at all times. Proactively evaluates safety issues and addresses them while encouraging input from all personnel.

Requirements

• BA in Engineering, Biology, Chemistry, Biochemistry, Microbiology, or other related science with a minimum of 10 years of work experience, or a Master’s degree with 8 years of work experience.
• Minimum 6 years of experience in sterile product development and operations, aseptic facility controls, or a 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 a track record of excellent decision-making and issue resolution.
• Demonstrated ability to work in cross-functional teams and across the business, with persuasive and effective negotiation skills.
• Experience in written and oral communication with health authorities (e.g., FDA, EMA).

Benefits

• Medical, dental, and vision insurance.
• 401k match.
• Flexible time off and a number of paid holidays, including year-end shutdown.
• Annual performance incentive bonus.
• New hire equity and ongoing performance-based equity.

Pay

The anticipated base pay range for this role is $188,500–$243,500. The exact base pay offered will depend on various factors, including the selected candidate’s unique set of qualifications, skills, and experience, as well as current organizational needs.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity, consisting of direct selective virus-mediated killing of the tumor, resulting in the release of tumor-derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options.