Director, Engineering

3 days ago

Framingham, United States Replimune Group, Inc. Full time

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. We imagine a world where cancer is a curable disease.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.

Join us, as we reshape the future.

Job Summary:

The Director Engineering will lead the engineering team in support of GMP and non-GMP facilities, utilities, equipment, and automation used in manufacturing of drug substance and aseptic fill/finish, and associated support areas. The ideal candidate will have a strong background in biotechnology and pharmaceutical engineering, with a proven track record of leading successful teams, capital project management and driving technological innovation.

The Director will be responsible for identifying opportunities to improve robustness, reliability, cost of goods and will develop and promote engineering best practices and ensure compliance with site SOP's, safe work practices, training programs, and cGMP regulations. The Director Engineering works with key stakeholders to plan and manage operational budgets and capital investments.

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

Responsibilities

Key responsibilities:

* Lead and mentor a team of engineers, fostering a collaborative and innovative work environment.
* Oversee the planning, execution, and completion of engineering projects, ensuring they meet quality, budget, and timeline requirements.
* Provide technical guidance and support in the design, development, and optimization of biotechnological processes and equipment.
* Drive the development and implementation of cutting-edge technologies to enhance product development and manufacturing processes.
* Ensure all engineering activities comply with regulatory standards and industry best practices.
* Work closely with cross-functional teams, including Manufacturing, Process Development, Validation, and Quality Assurance to achieve company goals.
* Identify opportunities for process improvements and implement strategies to enhance operational efficiency.
* Provide engineering support to UK-based quality control / research facility.

Other responsibilities

* Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
* Support equipment and process related non-conformance investigations and change control activities.
* Ensure training for department is kept in GMP compliant state.
* Role is US-based at manufacturing facility in Framingham, MA and may require occasional travel to Milton Park, UK facility.
* Other duties as assigned.

Qualifications

Education:

* Bachelor's or Master's (preferred) degree in Engineering, Life Sciences, or a related field.

Required Experience:

*
* Minimum of 10+ years of experience in engineering within the biotechnology or pharmaceutical industry with at least 5 years in a leadership role.
* Excellent knowledge of biotechnological processes, equipment design, and regulatory requirements.
* Proven ability to lead and inspire a team, with excellent communication and interpersonal skills.
* Strong analytical and problem-solving abilities, with a focus on innovation and continuous improvement.
* Familiarity with FDA, EMA, and other regulatory bodies' guidelines and requirements.
* Detail-oriented with a commitment to quality and compliance.
* Ability to work collaboratively in a fast-paced, dynamic environment.

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.

  • Senior Director of Platform Engineering

    3 weeks ago

    Framingham, Massachusetts, United States ICONSTAFF Full time

    Job OverviewOur client, a world-renowned leader in consumer technology, seeks a visionary Senior Director of Engineering to spearhead their next generation of innovative products. This is a chance to elevate your career and leave your stamp on a global brand as its products and delivery methods evolve.You will lead a world-class software development team...

  • Senior Director of Platform Engineering

    2 weeks ago

    Framingham, Massachusetts, United States ICONSTAFF Full time

    Job DescriptionICONSTAFF, a world-renowned leader in consumer technology, seeks a visionary Senior Director of Engineering to spearhead their next generation of innovative products. This is a chance to elevate your career and leave your stamp on a global brand as its products and delivery methods evolve.Key Responsibilities:Lead full stack and embedded...

  • Senior Director, OMS Engineering

    2 weeks ago

    Framingham, Massachusetts, United States Staples Full time

    The Senior Director, OMS Engineering will partner with both the business and technical teams to build and maintain a scalable platform for Staples Order Lifecycle Management Platform. This leader is responsible for working with business teams to define the vision for the Order Management platform, support business growth, and provide technical guidance and...

  • Acoustics Engineering Director

    3 weeks ago

    Framingham, Massachusetts, United States Bose Professional Full time

    Job OverviewBose Professional is seeking a highly skilled and innovative Head of Acoustics Engineering to lead our R&D initiatives in designing and building next-generation professional audio speaker systems. As a key member of our engineering team, you will collaborate with cross-functional teams to drive innovation, develop new products, and optimize...

  • Acoustics Engineering Director

    4 weeks ago

    Framingham, Massachusetts, United States Bose Professional Full time

    Job Title: Head of Acoustics EngineeringJob Summary:Bose Professional is seeking a highly skilled and experienced Head of Acoustics Engineering to lead our R&D initiatives in designing and building next-generation professional audio speaker systems. As a key member of our engineering team, you will collaborate with cross-functional teams to drive innovation,...

  • Senior Director of Validation

    3 weeks ago

    Framingham, Massachusetts, United States Replimune, Inc. Full time

    Job SummaryThe Senior Director of Validation will lead the validation team and oversee all validation activities related to equipment, systems, processes, and computerized systems and software within the company. This is a Global role, responsible for validation activities at the Framingham, MA (US) Manufacturing facility and Milton Park, Abingdon (UK)...

  • Director of Facilities Management

    1 week ago

    Framingham, United States Veracity Full time

    Director of Facilities Management Framingham, Massachusetts Manages the Facilities Management Department, which includes Engineering, Plant Operations, Biomedical Engineering, Grounds Maintenance and Security. Assists administration with planning of construction projects and facility expansion, overseeing office buildings and off-site clinics. Assumes the...

  • Associate Creative Director Digital/Art

    3 weeks ago

    Framingham, Massachusetts, United States Bose Full time

    About the RoleWe are seeking a highly skilled Associate Creative Director Digital/Art to join our team at Bose. As a key member of our creative department, you will be responsible for developing and executing innovative digital marketing campaigns that drive business results.Your primary focus will be on creating engaging and impactful digital experiences...

  • Sr. Director, Validation

    1 week ago

    Framingham, United States Replimune, Inc. Full time

    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. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United: We Collaborate for a Common...

  • Data Product Management Director

    2 months ago

    Framingham, Massachusetts, United States Staples Full time

    Job Title: Data Product Management DirectorStaples is a business-to-business company that relies on its digital solutions team to drive its success. We are a team of passionate, collaborative, and results-oriented problem solvers who are committed to delivering customer-centric technology services.Key Responsibilities:Develop and communicate a clear vision...

  • Steam Lab Specialist

    1 month ago

    Framingham, United States South Middlesex Opportunity Council Full time

    SUMMARY The STEAM Lab Specialist should be a fun, creative, energetic and dynamic instructor. This person should have the ability to create, design and lead engaging learning experiences centered around Science, Technology, Engineering, Arts & Math. This is a New STEAM lab, a great opportunity to get in from the ground up. PRIMARY RESPONSIBILITIES Deliver...

  • STEAM Lab Instructor

    2 weeks ago

    Framingham, Massachusetts, United States South Middlesex Opportunity Council Full time

    Job Summary:The South Middlesex Opportunity Council is seeking a skilled and dynamic STEAM Lab Specialist to join our team. As a STEAM Lab Specialist, you will be responsible for creating and delivering engaging learning experiences centered around Science, Technology, Engineering, Arts, and Math for preschool and younger school-age children.Key...

  • STEAM Lab Instructor

    4 weeks ago

    Framingham, Massachusetts, United States South Middlesex Opportunity Council Full time

    Job SummaryThe STEAM Lab Specialist will be responsible for creating and leading engaging learning experiences centered around Science, Technology, Engineering, Arts, and Math for preschool and younger school-age children.Key ResponsibilitiesDeliver age-appropriate STEAM-oriented instruction through project-based learning methods.Create a schedule to include...

  • STEAM Lab Educator

    2 weeks ago

    Framingham, Massachusetts, United States South Middlesex Opportunity Council Full time

    Job SummaryThe STEAM Lab Educator will be responsible for creating and delivering engaging learning experiences centered around Science, Technology, Engineering, Arts, and Math for preschool and younger school-age children. This is a unique opportunity to get in on the ground floor of a new STEAM lab and make a lasting impact on the community.Key...

  • Quality Assurance Manager

    4 weeks ago

    Framingham, Massachusetts, United States Replimune, Inc. Full time

    Job SummaryThe Manager, Plant Quality Assurance (PQA) plays a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes. Reporting to the Associate Director, Quality Assurance, this position is responsible for overseeing the quality oversight of products, from manufacturing to distribution, in accordance with...

  • Windchill Configuration Specialist

    4 weeks ago

    Framingham, Massachusetts, United States Bose Professional Full time

    Job Title: Windchill Configuration AnalystBose Professional is a leading company in the professional audio industry, specializing in cutting-edge audio solutions. We are seeking a skilled Windchill Configuration Analyst to join our team.Job Summary:The Windchill Configuration Analyst will play a crucial role in guiding and supporting our Product Development...

  • Plant Quality Assurance Manager

    2 weeks ago

    Framingham, Massachusetts, United States Replimune, Inc. Full time

    Job Summary: The Manager, Plant Quality Assurance (PQA) plays a pivotal role in ensuring the highest standards of quality in our manufacturing processes. Reporting to the Associate Director, Quality Assurance, this position is responsible for overseeing the on-going Quality oversight to guarantee that products are manufactured, tested, stored, and...

  • Windchill Configuration Analyst

    3 weeks ago

    framingham, United States Bose Professional Full time

    Company Overview: Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing devices, controls, software, and accessories. As we continue to expand our team, we are seeking a Windchill Configuration Analyst to join us on...

  • Windchill Configuration Analyst

    1 month ago

    Framingham, United States Bose Professional Full time

    Company Overview: Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing devices, controls, software, and accessories. As we continue to expand our team, we are seeking a Windchill Configuration Analyst to join us on...

  • Windchill Configuration Analyst

    1 month ago

    Framingham, United States Bose Professional Full time

    Company Overview: Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing devices, controls, software, and accessories. As we continue to expand our team, we are seeking a Windchill Configuration Analyst to join us on...