Job Description

Opportunity Description

This position will perform routine chemical analysis on in-process, finished product, stability, and raw material samples during product development. The scientist is expected to develop good stability, indicate HPLC, UPLC, and GC methods, and execute method validation. The scientist is expected to work independently under the group leader's or designee's supervision. 

Company Information

Generic pharmaceuticals

Job Duties

• Support characterization of formulation development trial samples by conducting various analytical tests of various dosage forms such as parenteral, topicals, transdermal, solid orals and nasal products
• Conduct and support pH solubility, excipient compatibility, and container closure compatibility studies.
• Analytical testing of the Injectables (oncology), ophthalmic solutions/suspensions, and other dosage forms. 
• Review, propose testing plans, conduct testing, generate data, and provide summary data. 
• Review and propose compendial and FDA dosage development testing requirements 
• Review and summarize DMF technical information
• Conduct investigations and deviations under the supervision of a team leader and recommend solutions where possible. Prepare reports as needed.
• Prepare protocols and reports for stability, method validation, comparative studies, and process validation.
• Prepare and Review specifications, test methods, and test results as needed.
• Conduct methods verification and method transfer of validated analytical procedures as required.
• Maintain proper laboratory notebooks and prepare ARD/QC reports where applicable.
• Respond to all data reviews on a timely basis.
• Basic troubleshooting abilities.
• Support management in responding to audit findings on a timely basis.
• Complies with all relevant standard operating procedures (SOPs).
• Follow all lab safety and housekeeping requirements.
• Perform other duties as assigned.

Education

• BS in chemistry or related field with 8+ years’ experience
• MS in chemistry or related field with 5+ years’ experience
• PhD in chemistry or related field with 2+ years’ experience 

Experience & Skills Required

• Good instrumentation skills, including HPLC, UV-Vis, UPLC, and USP dissolution.
• Working knowledge of parenteral and ophthalmic product analytical development techniques.
• Demonstrated knowledge of TGA DSC and other physical characterization techniques.
• Ability to enter data accurately and must have the ability to handle multiple tasks well.
• Must have advanced skills in Microsoft applications.
• Excellent interpersonal skills and ability to establish and maintain effective working relationships with both internal and external stakeholders.
• Experience is expected to be in analytical labs, preferably in the pharmaceutical industry
• Ability to prioritize and plan the daily work to meet project timelines and manage multiple projects.
• Be independent.
• Responsible for ensuring that assigned projects and all lab activities are completed on schedule and within budget.
• Superior verbal and writing skills and interpersonal skills.
• Ability to work in a team environment and to facilitate teamwork.
• Ability to facilitate communication with other groups.