Director, Engineering

2 months 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.

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