PD (Ops) Senior Scientist – Materials Attributes and Technologies (Framingham, MA)
Summary of job description:
We are a fast-paced growing innovative company that has recently brought 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 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 our products. The Senior Process Development Scientist – Materials Attributes and Technologies will serve as the 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.
- Provide scientific expertise and technical support to serve as an authority in materials (e.g. plastics, rubbers, elastomers, etc.) of single-use systems and components (e.g. bioreactors, mixing systems, tube sets, drug product vials, etc.) for biopharmaceutical manufacturing.
- Lead a collaboration with QC Analytical team(s) to evaluate, test, and assess extractables and leachables from plastic component materials used in the production process
- Author sections of applicable regulatory filings
- 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
- Build and oversee 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.
- 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
- Additional duties and responsibilities as required
- 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
- Doctorate degree in applicable field (chemical engineering, materials science, etc.) and 2 to 4 years of related work experience
- Master’s degree in applicable field (chemical engineering, materials science, etc.) and 4 to 6 years of related work experience
- Bachelor’s degree in applicable field (chemical engineering, materials science, etc.) and 6 to 8 years of related work experience
Experience and skill requirement:
- 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 technologies
- 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