Director, Manufacturing

Replimune Group; Framingham (MA); On-site; USD 188,500 - 243,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays (year-end shutdown)

Job summary

Replimune Group, Inc. in Framingham, MA is seeking a Director Manufacturing to define and oversee drug product manufacturing operations, ensuring sterile quality and compliance to international standards.

Reporting to the Senior Director of Manufacturing, you will lead aseptic operations, collaborate with cross-functional teams, and drive continuous improvement while building a capable Sterile Operations team for commercial readiness.

Qualifications

• 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)

Responsibilities

• 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 Operationsteam 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

Skills

Aseptic operations

GMP compliance

Team leadership

Risk management

Process controls

Good communication

Education

Bachelor's/Master's in Science (Engineering/Biology/Chemistry/Biochemistry/Microbiology)

Job description

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.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

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.

Join us, as we reshape the future.

Summary of job description

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.

Key responsibilities

• 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 Operationsteam 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

Educational 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

Experience and skill requirement

• 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)

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $188,500- $243,500. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate's unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

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. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.