Research Scientist II - Stability
AMRI - Albany, NY

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Job Description
: The principal responsibility of the Research Scientist is the analysis by multiple procedures of intermediates and target compounds. The Research Scientist is expected to demonstrate expertise in both the theoretical and practical aspects of analytical chemistry. A major component in the scientist's performance rating will be based on productivity. In general, technical, organizational and compliance support for 170+ ongoing stability studies.

MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Review of analytical data and documentation for compliance with cGMPs, AMRI SOPs and other written procedures. Primarily chromatographic data, but also instrumental testing such as DSC, XRPD, water analysis, USP testing, etc… Identification of deviations. Trending of stability data to ensure consistency with historical timepoints and no unexpected results.

2. Managing timelines and multiple projects: Interface with scientists and management to coordinate testing timelines, corrections to documentation, and reporting within defined turnaround times. Adjusting priorities based on due dates and invoicing goals.

3. Writing stability protocols.

4. Interfacing between sites (Albany and Rensselaer) to coordinate testing for efficiency and use of site-exclusive equipment.

5. Direct, technical communication with customers (primarily, external). Reporting results, technical discussion, addressing questions.

6. Formatting and review of reports: Stability Summary tables; accuracy and compliance with current AMRI formats.

7. Supervisory skills – this position currently has oversight for a lab tech (who is responsible for chamber maintenance, calibrations of lab equipment, packaging stability samples, logging in samples, etc.).

8. Managing invoicing for stability: issuing BRFs, working with finance to ensure accurate and complete accounting for stability projects, review of monthly invoices. Tracking monthly and quarterly financial projections.

9. Controlled substances handling including maintaining inventory, paperwork, biannual review.

10. Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.

11. Volunteer to assist with other tasks in the analytical function not directly related to specific projects.

12. Participate in self-development activities and training of others.

13. Perform other related duties as may be reasonably assigned in the course of business.

Job Requirements
: · Bachelors or Masters Degree with major in Natural Science or Pharmacy or equivalent.

· Between 3 to 7 years prior relevant industrial experience is required.

· Chemical Hygiene training

· Other pertinent training/courses

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