Assist with providing high quality analytical method development and validation in a GMP environment. Support new product development through analysis of innovator samples and R&D formulations.
- Participate in 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 support formulation development through testing and evaluation of R&D formulations.
- Assist in the evaluation and interpretation experimental data.
- Assist in the resolution of complex 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.
- Maintain and follow all laboratory systems, GMPS.
- Adhere to safety and housekeeping requirements.
- 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 SOPs, as required.
- Keep supervisor informed of all key quality findings and issues. Seek guidance on resolution of complex issues
- Assume other activities and responsibilities as directed.
- Minimum BS in Organic Chemistry or related discipline with at least 1-3 years of experience in the Pharmaceutical Industry or equivalent experience.
- 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.
- Strong problem solving skills.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team members and company priorities.
- Well-developed interpersonal skills.
- Good written and oral communications.
- Demonstrated ability to work on multiple projects and meet timelines.
- Physical Demands
- Ability to lift 20-30 pounds
- Inside and outside work
- Move between buildings
- Temperature variations
- Sit and stand for long periods
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