Analytical Development Scientist – Framingham, MA
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space. Working in collaboration with colleagues within Analytical Development and Process Development, the Analytical Development Scientist will be the Framingham site lead for analytical assay transfer and optimization in support of process development activities and commercialization of the cGMP manufacturing facility. In addition, there will be opportunities to participate in projects within process development.
- Lead assay transfer / implementation and maintenance, including reagent and instrument qualification, as well as assay troubleshooting for HSV viral based products
- Support process development characterization and optimization activities for products in late stage development / commercial
- Perform biological activity assays to measure viral titer, quantitative assays to measure viral titer and genome titer, and assays measuring the levels of residual host DNA, protein, and other process-related impurities
- Perform data analysis using various software packages
- Author protocols, reports, risk assessments, SOPs, and batch records
- Collaborate with the global Analytical Development and Process Development team(s) in efforts to acquire product and process knowledge of the platform process and transfer this knowledge to the Framingham facility
- Plan and manage key elements in the start-up / commissioning of the analytical development lab at the Framingham facility
- Work in cross-functional teams with QC and QA to support and improve assays used in conjunction with GMP production within the QC Analytical laboratories.
- Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding
- Ensure effective, high-quality, timely and appropriate documentation in laboratory notebooks
- Assist with authoring sections of applicable regulatory filings
- Additional duties and responsibilities as required
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance
- 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 analytical development
- Some travel may be required, both in country and international
- Master’s degree and 2 to 4 years of related work experience
- Bachelor’s degree and 4 to 6 years of related work experience
Experience and skill requirement:
- Minimum of 2 years working in biologics drug substance analytical development role
- Experience maintaining analytical development laboratory / assay demands with minimal supervision.
- 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
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
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