|Reference # : ||17-00892
||Title : ||Scientist for Manufacturing/R&D Interface|
New Brunswick, NJ
|Position Type : ||Contract|
|Experience Level : ||
||Start Date : ||06/16/2017
| Description |
SCIENTIST FOR MANUFACTURING/R&D INTERFACE
NEW BRUNSWICK, NJ
Working within the Small Molecule Pharmaceutical Manufacturing Science & Technology Department, reporting to the associate director, responsible for:
? Conducting product and process assessments, collaborating with manufacturing site as well as research and development in drug product process development.
? Providing manufacturing input to the development teams.
? Supporting technology transfer from R&D to the manufacturing sites (or site to site transfers within manufacturing) using principles defined in ICH, FDA, and other regulatory guidelines.
? Monitoring, optimizing and troubleshooting product and manufacturing processes such as granulation, compression, blending, and coating.
? Covers activities on internal and external manufacturing sites within the global product development and supply organization.
? Works in full compliance with laws, industry regulations, policies and procedures including business rules as well as the standards of business conduct and ethics.
? Support technology transfer related activities from development to launch of new drug products with a particular focus on granulation and compression.
? Review and provide input to design and studies for manufacturing processes and specification setting.
? Evaluate product performance based on development knowledge and predict manufacturing performance.
? Support validation activities at the manufacturing site.
? After transfer to manufacturing: analyze trends and criticality in product/process/equipment performance and ensure robust processes are in place and remain in a state of control.
? Troubleshooting of manufacturing processes.
? BS or MS with a minimum of 2 years working experience in: pharmaceutics, industrial pharmacy, pharmaceutical science, chemical engineering, material science.
? Fluent English
? Good communication and technical writing skills, diligent, energetic, fast learner.
? Experience with small molecule drug product manufacturing processes/unit operations.
? Beneficial to have understanding of formulation development, commercial manufacturing, and relevant unit operations.
? Scale-up knowledge for unit operations.
? Knowledge of relevant QbD, DOEs, CPP, critical material attributes and CQA's.
? Understanding of six sigma tools and principles.
? Skilled to write and complex study plans and scientific reports.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen: email@example.com
ALPHA'S REQUIREMENT #17-00892