Responsibilities :
- 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
- 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 company 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
Top Must Have Skill Sets :
- Firm knowledge of Engineering and Scientific concepts
- Communications and writing skills
- Biopharmaceutical experience
- Willingness to learn
Compensation :
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).
Benefits and Ancillaries :
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
30+ days ago