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Scientist I - Analytical Development
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 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
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
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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