Location: Buena, NJ
- Provide high quality analytical method development and validation in a Good Manufacturing Practice (GMP) environment. Support new product development through analysis of innovator samples and R&D formulations.
- Ensure the development and validation of analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through formulations and process development and ANDA submission of oral and topical products Actively lead formulation development through reverse engineering of innovator samples and through testing and evaluation of R&D formulations. Critically evaluation and interpret experimental data.
- Ability to resolve complex research problems.
- Prepare and review analytical data, technical reports and analytical methods in support of and for inclusion in the regulatory submissions. Compile, maintain, review and interpret analytical and statistical data.
- Assist with generating high quality technical documents required for method validation and ANDA submissions.
- Manage Analytical deliverables for ANDA projects ensure that necessary supplies such as: standards, reagents, columns, impurities are available on time for projects.
- Prepare and review Standard Operating Procedures (SOPs), as required.
- Knowledge of cGMPs, and CMC regulatory requirements and their utilization to support ANDA product registration.
- Strong foundation in the principles and applications of HPLC and detection systems, GC, UV/VIS, and other methodologies.
- Minimum BS in Pharmacy, Pharmaceutical Science or Chemistry plus 5 + years of experience in the Pharmaceutical Industry or equivalent experience. MS + 2 years in the alternative.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs