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US: Scientist I - Analytical Development

Date: 20-Aug-2015
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Scientist I - Analytical Development

KEY DUTIES:

Perform and record analyses as assigned on a daily basis. Adhere to cGMPís in all work practices. ICH Guidelines and Compendial Requirements Attend training sessions as appropriate. Assist in maintaining a clean, safe workplace on a daily basis. Review peer's work as needed. Review revisions to procedures as needed. Write SOPs Write and disseminate technical data summaries and reports Contribute to CMC section reports. Train other colleagues in methods and procedures. Develop new chemical assays; write method qualification/validation protocols and reports Lead team by ensuring execution of work assignments by laboratory staff to meet cycle times. Routine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other leaders for assistance and closeout of work activities. Providing technical leadership through informal and formal training mechanisms. Lead technology transfers

Develop technical strategies to meet customers technical and business needs

Direct and foster the professional development of scientific associates Design experimental plans to address specific program issues Lead technology transfers Plan comprehensive stability studies Interpret, analyze, and manage data Prioritize tasks and responsibilities for projects. Troubleshoot technical problems for development and manufacturing Write project proposals, and development reports Plan, write and execute validation and technology relocation protocols. Present plans and data to key stakeholders and management Coordinate activities of outside resources such as consultants, vendors

SKILLS/ABILITIES:

Advanced Analytical Chemistry (Dissolution, HPLC, GC, FTIR, UV/Vis, KF, LC/MS etc.) Knowledge of pharmaceutical sciences Statistical analysis for Analytical Chemistry Computer applications and proficiency cGMPs, ICH Guidelines and Compendial Requirements Experimental design Project planning and management Collaborate in the design and execution of formulation and process development experiments Oral and written communications Data recording, interpretation, and management Mentoring of junior staff

EDUCATION AND EXPERIENCE:

Masterís Degree in Chemistry with 3-5 years of experience or Bachelorís Degree in Chemistry with 6+ years of experience Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/