Sr. Scientist, Process Development & Technology

Replimune; Framingham (MA); On-site; USD 146,000 - 189,000; Full time

Job summary

Replimune, based in Massachusetts, is seeking a Senior Process Development Scientist – Materials Attributes and Technologies to advance control strategies for single-use materials used in commercial manufacturing.

You will serve as a subject matter expert for processing materials, assess suitability and robustness, and lead projects in process characterization and new technologies. Join a team focused on improving cGMP steps and ensuring regulatory readiness.

Qualifications

• Bachelor’s degree in a relevant field; advanced degree preferred.
• 2+ years in a materials science role, preferably in biologics substance/product development or manufacturing support.
• Experience with single-use manufacturing materials (plastics, glass, etc.).
• Experience with ultra-low cold chain insulation materials / development.
• Strong cross-functional collaboration.
• Excellent communication and teamwork.

Responsibilities

• Serve as a materials SME to support manufacturing with evaluation of change controls, deviations, CAPAs, and supplier change notifications.
• Lead material risk assessments considering supply, processes, products, and customers.
• Develop a material trending program to monitor performance and quality attribute consistency.
• Lead process characterization experiments and process validation exercises.
• Provide technical troubleshooting for material issues in drug substance and drug product; participate in MRB.
• Drive continuous improvement in cGMP steps through technology and alternative approaches.
• Collaborate with QC Analytical to evaluate extractables and leachables from plastics.
• Contribute to cross-functional teams toward production readiness and regulatory filings.

Skills

Materials science

Cross-functional collaboration

Process development

Experiment design

Education

Bachelor’s degree in relevant field

Tools

Single-use manufacturing materials

Process characterization methods

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.

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:

Working in collaboration with cross functional teams, the Senior Process Development Scientist – Materials Attributes and Technologies will support the development of control strategies for predominantly single use disposable materials used in the commercial manufacturing of Replimune products. The Senior Process Development Scientist – Materials Attributes and Technologies will serve as a subject matter expert for processing materials, assessing and defining their suitability, compatibility and robustness for use. In addition, there will be opportunities to lead projects for process characterization and/or support the introduction of new process technologies.

Key responsibilities:

• Serve as a materials subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions, and supplier change notifications.


• Lead technical material risk assessments to consider impact to supply, processes, products, and customers.


• Help build a material trending program to monitor material performance, potential process performance shifts as a result of change notifications, and consistency of quality attributes.


• Lead process characterization experiments and process validation exercises.


• Provide technical expertise to troubleshoot material issues within drug substance and drug product production. Be an active permanent member of site material review board.


• Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of alternative technologies.


• Collaborate with QC Analytical team to evaluate, test, and assess extractables and leachables from plastic component materials used in the production process.


• Actively contribute to cross functional teams to achieve production site and company goals in support of commercial production readiness.


• Assist with authoring sections of applicable regulatory filings.


• Additional duties and responsibilities as required.

Other responsibilities:

• Practices and promotes safe work habits and adheres to safety procedures and guidelines.


• Provide technical representation during internal and external audits.


• Keeps up to date with current technologies and trends in biologics manufacturing operations and support.

Educational requirements:

• Bachelor’s degree in applicable field with advanced degree preferred.

Experience and skill requirements:

• Minimum of 2 year working in a materials science role, preferably in a biologics drug substance and/or drug product process development / manufacturing support role.


• Experience with single-use manufacturing technology materials (plastics, glass, etc.).


• Experience with ultra-low cold chain insulation materials / development.


• Demonstrated ability to work in cross-functional teams across the business.


• Strong organizational skills and attention to detail.


• Excellent written and oral communication skills and strong team player.

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 $146,000-189,000. 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.