Associate Director, CMC Data Science

Replimune Group; Framingham (MA); On-site; USD 160,000 - 207,500; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune Group in Framingham, MA seeks an Associate Director of CMC Data Science to lead cross-functional data science efforts for cGMP monitoring, DOEs, and AI integration into CMC workflows. You will guide a team, partner with IT, and influence commercial reporting with robust analytics.

The role requires 4+ years in data science within biologics CMC, strong stats, and leadership. On-site in Framingham, with a comprehensive benefits program.

Qualifications

• Bachelor's degree in applicable field
• 4+ years working in data science, preferably in support of biologics CMC
• Expert in statistical analysis, predictive modelling, and data visualization tools
• Experience with at least one data management system (data lake, data warehouse, or data lake house)
• Experience with ML/AI integration into CMC workflow(s)
• Demonstrated ability to work in cross-functional teams across the business
• Strong organizational skills and attention to detail
• Experience as a people manager
• Excellent written and oral communication skills and strong team player

Responsibilities

• CMC Statistical Lead and point of contact for statistical analysis requests across the CMC organizations
• Provide technical expertise and support to serve as an authority in GMP process monitoring (CPV) and key contributor to commercial annual product reports
• Lead creation of a data repository for all CMC data (e.g., electronic data warehouse) with IT
• Identify data flow issues with end customers and deliver short/long-term solutions in an agile manner
• Create tools to visualize risks to critical CMC workflows
• Embed AI-enabled CMC business processes into workflows to improve efficiency and decision-making
• Create / advise on DOEs for lab-based experiments supporting drug substance/product
• Drive continuous improvement in cGMP process steps
• Contribute to cross-functional teams to support production readiness
• Manage data science team members and ensure governance alignment
• Ensure data governance strategy enables data accessibility
• Provide representation during audits

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 patients' 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:

The Associate Director of CMC Data Science will work with cross-functional teams while applying the appropriate science-based techniques to:

• support / creation of cGMP process monitoring capabilities

• design statistically sound lab-based experiments

• solve operations and business problems

• support integration AI into CMC workflows in a compliant manner

• manage the CMC Data Science team

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

Key Responsibilities:

• CMC Statistical Lead and point of contact for statistical analysis requests across the CMC organizations

• Provide technical expertise and support to serve as an authority in GMP process monitoring (CPV) and key contributor to commercial annual product reports.

• Working with IT, serve as a team leader / project lead for the creation of data repository for all CMC data (e.g. electronic data warehouse)

• Identify data flow issues working with end customers to understand needs and deliver short term and long-term solutions to help scientist/engineers/managers complete their deliverables in an agile manner

• Working with site / group leaders create tools to better visualize potential risks and issues to critical CMC workflows

• Work with cross functional customers to embed AI-enabled CMC business processes into existing workflows to improve efficiency, decision-making, and innovation

• Create / advise on DOEs to be used within lab-based experiments supporting both drug substance and drug product production.

• Drive continuous improvement in our cGMP process steps by identifying process improvements

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

• Manage the members of the data science group to perform similar key responsibilities

• Ensure that all data science team members comply with the data governance strategy for operations to better enable data consumers to find, access, and use data

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 CMC data trending / warehousing / visualization tools and applications.

• Additional duties and responsibilities as required

Educational Requirements:

• Bachelor's degree in applicable field with advanced degree preferred

Experience and Skill Requirement:

• Minimum of 4 year working in data science role, preferably in support of biologics CMC.

• Expert in statistical analysis, predictive modelling, and data visualization tools

• Experience with at least one data management system (data lake, data warehouse, or data lake house)

• Experience with ML/AI integration into CMC workflow(s)

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

• Strong organizational skills and attention to detail.

• Experience as a people manager

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 $160k-$207,500The 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.