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
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"
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Biotechnology
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