Alka Patel held the position of Associate Research Scientist III, and participated in validation, releases, stability testing and instrument calibration. With the current workload and upcoming projects in 2015, an Associate Research scientist is needed with the strong analytical background and experience in the pharmaceutical industry to provide Routine testing for release and stability ,Instrument calibration , Dissolution experience , Method development, Method validation, and document preparation for the current and upcoming ANDA fillings.The Associate Research Scientist III assists with or independently conducts routine analyses, assists with method development and validation, documents results in notebooks and helps to prepare protocols and reports. As assigned, the Associate Research Scientist takes direction from senior AD scientists, executes required experiments independently and works safely and cooperatively in the laboratory.
Description of KEY responsibilities:
Assists in the development of robust methods for the analysis of API and drug product.
Efficiently carries out method validation experiments. Helps to prepare protocols and reports.
Participates in investigations and completes all required documentation in a timely manner.
Writes or contributes to the design of SOPs.
Participates actively on project teams.
Keeps accurate notebook records in accordance with SOP and cGMP requirements.
Keeps management informed of all significant developments. Proposes solutions to problems.
Experience and education required
PhD + 0 or Masters +2 or Bachelor's +4 years' experience
Skills and specific knowledge required
Background or coursework in Analytical Chemistry with applicability to routine testing and method development and validation.
Practical knowledge of chromatography (HPLC, GC, TLC), spectroscopy (UV, FTIR) and related techniques is preferred but may be learned on the job. Good progress on these skills is a factor in advancement between Associate Research Scientist levels.
Able to learn troubleshooting, demonstrated by good analysis skills and/or coursework.
Strong communication and technical writing skills.
Work Environment and Physical Demands
Able to work productively and safely in a laboratory environment
Lifting up to 20 lbs.
Able to use personal protection equipment as required
Please refer to Qualifications