| Business Unit: | Over The Counter |
| Division: | Consumer Health |
| Company/Legal Entity: | USA Novartis Consumer Health, Inc., Parsippany, NJ |
| Work Location: | United States - Nebraska |
| Posting Functional Area: | Development |
| Job Type: | Full Time |
| Employment Type: | Permanent |
| Job Reference Code: | 56938BR |
This position is located in Lincoln, Nebraska.
Plans, manages and conducts the development and validation of analytical testing for new products in the NCH OTC's new product pipeline, and manages the execution of stability program for these new products that results in establishment of expiration dating and labeled storage conditions. Participates in Project Teams, assessing the viability of proposed projects, trouble-shooting, finding solutions and championing new product ideas. Identifies contract research laboratories and performs due diligence and GMP (Good Manufacturing Practice) audits. Develops project time lines, resource and budget estimates for both internal and external development projects and manages against these timelines and budgets while maintaining high quality standards. Conducts or manages routine testing of R&D batches, i.e. prototypes, experimental formulas, stability, clinical supply and validation batches, and of new raw materials. Conducts experiments, investigations, and special testing as needed for problem solving, to resolve regulatory issues, or to characterize drug substances or products. Responsible for preparation of the analytical and stability portions of the 'Chemistry, Manufacturing, and Controls' section of NDAs and other regulatory submissions. Provides technical and compliance training and mentoring to junior analysts. Partners and closely interacts with other functional departments within NCH OTC (i.e., Pharmaceutical Development, New Technology, R&D QA, Global Manufacturing Supply, Global Regulatory Affairs, Marketing) and third-party suppliers and contractors. Able to conduct thorough literature searches to support development projects efficiently. Able to work on global projects independently. Contributes to the maintenance of a GMP compliant, state-of-the-art analytical and stability laboratory.Degree(s) in chemistry or related disciplines. Typically requires minimum education and experience as follows:
Ph.D. with 2-6 years relevant experience, MS with 6+ years or BS with 8+ years.
* Thorough knowledge of chemical principles; Excellent analytical skills; Excellent written and communication skills; Thorough experience in analytical instrumentation, GMPs, and validation of analytical procedures; Should be creative and show initiative.
![]()
Novartis