For more than 20 years, as Albany Molecular Research Inc. (AMRI), we have provided fully integrated drug discovery, development and manufacturing services – all while adapting to the rapidly changing needs of our customers within the pharmaceutical, biotechnology and related industries.
With locations in the United States, Europe and Asia, AMRI SMARTSOURCING™ offers you a versatile and strategic way of partnering with us that is designed to deliver reduced risk, greater flexibility and a better return on investment. AMRI has successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development.
Post:Reserch Scientist II - Stability Coordinator - 1000444
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
- 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. 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. Writing stability protocols. Interfacing between sites (Albany and Rensselaer) to coordinate testing for efficiency and use of site-exclusive equipment. Direct, technical communication with customers (primarily, external).
- Reporting results, technical discussion, addressing questions. Formatting and review of reports: Stability Summary tables; accuracy and compliance with current AMRI formats. 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.
- Controlled substances handling including maintaining inventory, paperwork, biannual review. Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.
- Volunteer to assist with other tasks in the analytical function not directly related to specific projects. Future: writing proposals and designing studies for stability
Candidate Profile
• Bachelors or Masters Degree with major in Natural Science or Pharmacy or equivalent.
• Between 3 to 7 years prior relevant industrial experience is required.
Additional Information:
Experience: 3-7 years
Qualification: M.Pharm, B.Pharm
Location: US-NY-Albany
Industry Type: Pharma/Biotech/Scientific
Requisition Code: 1000444
Last Date: 19th october, 2016
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