Senior Research Scientist


Job ID 17-00148

Industry Pharma

Job Type Permanent

Location Buena, NJ

Description

Job Summary:
Senior Research Scientist will 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.
Essential Responsibilities:
- 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.
- Generate and compile documents for ANDA submissions and response to deficiency letters from FDA.
- Critically evaluate and interpret experimental data for conclusions and resolution.
- Resolve complex problems. Provide suggestions and problem resolution based on technical expertise.
- Supervise analytical testing in support of formulation development of topical and oral dosage forms.   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.
- Conduct investigations and write investigation reports, as appropriate.
- Maintain and follow all laboratory systems, GMPS.
- Establish collaborative working relationships with product development, quality control and other groups to ensure consistency and suitability of analytical methods throughout the drug development process.
- 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 management informed of all key quality findings and issues.
- Provide guidance on resolution of complex issues to junior staff.
- Train and mentor junior staff .
- Assume other activities and responsibilities as directed.



Qualifications

Qualifications:
- Minimum BS in Organic Chemistry or related discipline with at 10 + years of experience in the Pharmaceutical Industry or equivalent experience. MS/PhD preferred.
- 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.