Description:
Note: 100% Onsite Cambridge, MA Job Details: Bachelors' degree & 2 YOE. As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. Responsibilities include: Monitor or follow established experimental design and protocols and perform routine tasks and studies to obtain reproducible and reliable results with limited supervision Plan, monitor or conduct, analyze and records experiments, and provide interpretation of data Effectively transfer experimental methods from literature to the lab and make modifications as necessary Develop and implement new protocols with moderate review Engage coworkers in scientific discussions Communicate data and interpretation to work group Effectively trouble-shoot equipment and experimental difficulties Contribute to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents Participate in department-wide support efforts such as safety, recruiting and committees Coordinate and organizes resources needed to complete the task. Basic Qualifications 1+ Years w/ Relevant MS OR equivalent 3+ Years w/ Relevant BS OR equivalent Complete understanding and use of technical principles, theories, and concepts to perform a wide range of work in a role. Top 3 Must Have Skill Sets: Firm knowledge of Engineering and Scientific concepts Communications and writing skills Biopharmaceutical experience Willingness to learn Day to Day Responsibilities: Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations Develop solutions to technical problems during process characterization and aseptic manufacturing Support one or more clinical and commercial process introductions or process transfers into Amgen manufacturing network Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships Pay Rate - between $30 - $33/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
