Process Development Senior Scientist, Drug Product

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Flexible PTO

Paid Holidays

Job summary

Replimune in Framingham, MA is seeking a Process Development Senior Scientist who will lead late-stage drug product process characterization, support PPQ and regulatory readiness, and collaborate with cross-functional teams to optimize GMP DP processes.

You will develop stable formulations, contribute to PD workflows, author protocols and batch records, and drive continuous improvement through innovative technologies.

Qualifications

• Minimum 2 years in biologics drug product process development.
• Experience working in cross-functional teams across the business.
• Experience with frozen liquid and lyophilized drug product formulation development.

Responsibilities

• Lead late stage drug product process characterization and product characterization studies.
• Provide SME support for GMP DP production processes and PD workflows.
• Represent PD in DP process validation exercises and regulatory filings support.
• Author protocols, reports, risk assessments, SOPs, and batch records.
• Advise on change controls, deviations, and CAPAs in manufacturing operations.
• Drive continuous improvement in cGMP steps through new technologies and processes.
• Collaborate with site teams to achieve production readiness for commercial use.

Skills

Biologics DP development

Cross-functional teamwork

Formulation development

Documentation & writing

Attention to detail

Education

Bachelor’s degree in applicable field

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 Process Development Senior Scientist will be responsible for:

• Leading process characterization and product characterization studies


• Providing subject matter expertise and practical technical support for GMP drug product production processes, optimization and improvement of GMP DP process steps and PD workflows supporting these efforts.


• Representing PD as part of DP process validation exercises and in support of product commercialization.

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

Key responsibilities

• Execution of late stage drug product process characterization and product characterization studies to support PPQ, BLA, and Commercial readiness.


• Project management / execution of experiments to develop stable formulations for Replimune products


• Experience with technology / assays to measure size and concentration of sub-visible and sub-micron particles (e.g. nanosight and flow cam)


• Author protocols, reports, risk assessments, SOPs, and batch records


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


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


• 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


• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.


• Some travel may be required, both in country and international

Educational requirements

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

Experience and skill requirements

• Minimum of 2 year working in a biologics drug product process development role.


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


• Experience with frozen liquid and lyophilized drug product formulation development


• 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.