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.
Senior Research Scientist (Analytical Development): Perform analytical method dev research; product development through analysis of innovator samples & R&D formulations. Ensure drug development & validation development through formulations and reverse engineering of innovator samples. Ability to interpret data and analytics for regulatory submissions. Manage analytic deliverables for ANDA projects. Prepare and review SOPs. Knowledge of cGMPs, CMC reg req, application of HPLC and detection systems GC, UV/VIS. Req: MS Pharm, Pharma Sci, Chem + 2 yrs OR BS Pharm, Pharma Sci or Chem + 5 yrs in job or related. Contact B. Scavelli, Teligent, 105 Lincoln Avenue, Buena, NJ 08301.
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.