Process Development Senior Scientist – Drug Product
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 cross functional teams, the Process Development Senior Scientist will be responsible for technical aspects of technology transfer and support startup of the facility in the short term. Longer term, the Process Development Senior Scientist will provide subject matter expertise and practical technical support for drug product production processes, optimization and improvement of procedures, process characterization and process validation in support of commercialization. This individual will have an opportunity to establish all drug product manufacturing steps within a multi-product cGMP manufacturing facility. In addition, there will be opportunities to participate within important projects across the whole production process as they arise.
- Development and execution of process characterization for fill / finish production steps (e.g. automated filling systems, visual inspection, labeling and freezing of the drug products)
- Establish drug product manufacturing steps within the cGMP manufacturing facility during production start-up.
- Develop and support management of a visual inspection qualification set.
- Liaison to external vendors for process equipment / materials specifications, user requirements, procurement and technical support
- Author protocols, reports, risk assessments, SOPs, and batch records
- Act as the accountable point of contact from the Process Development organization for product/process support for technology transfers and ongoing cGMP drug product manufacturing.
- Use technical experience to troubleshoot issues with drug product processing technologies and equipment.
- Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions
- Drive continuous improvement in our cGMP process steps through technological innovation and application of experimental findings.
- Lead functional and cross functional teams to achieve company goals.
- 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 drug product processing
- Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.
- Some travel may be required, both in country and international
- Master’s degree and 4 to 6 years of related work experience or Bachelors’ degree and 6 to 8 years of related work experience
Experience and skill requirement:
- Minimum of 4 years working in biologics drug product process development / manufacturing support role.
- Experience with setting up, supporting, and troubleshooting multiple pieces of drug product manufacturing equipment (e.g. fill machine, labeler, semi-automated VI systems)
- Experience with single-use manufacturing technologies. Experience conducting process characterization 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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