Job Summary:

Laboratory position which involves development and validation of analytical methodology in support to the research projects involving testing of pharmaceutical components and/or drug products. This position also involves designing and completion experiments and providing scientifically sound recommendations based on the data obtained.

Job Responsabilities

• Developing new analytical methods using innovative solutions for actives, excipients, drug release, residual solvents and to support product development.
• Validating analytical methodologies following ICH guidance
• Executing complex experiments in support to R&D for development and validation of process under minimum supervision.
• Ability to identify creative and innovative solutions of non routine analytical tasks
• Improves analytical applications by implementing new analytical techniques
• Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.
• Writing/reviewing protocols, reports, SOPs, specifications & test procedures.
• Compiling necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDA), as required.
• Adhering to laboratory SOP guidelines, GMP requirements and safety rules.
• Maintaining analytical instrumentation through the proper performance and/or maintenance as required.
• Train junior scientists and QC chemists as necessary.
• Demonstration ability of problem solving and offer necessary recommendations.
• Works as a member of a team to achieve all outcomes
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• All other relevant duties as assigned

Job Requirements

• Education
  • Bachelors degree (B.S.) in chemistry or related field
  • Masters degree (M.S.)
  • or Ph.D.

• Knowledge, Skills and Abilities

• Proficiency in using analytical equipments such as UV/Visible and Infrared spectrophotometers, automatic titrators, pH potentiometers, dissolution apparatus, HPLC, GC, GC/MS, LC/MS/MS and other techniques as needed.
• Strong verbal and written communication skills, interpretation of experimental results, technical protocols and reports writing.
• Broad knowledge of methods development in support Active Pharmaceutical Ingredients, Intermediates, excipients and drug products.
• Ability to clearly indentify problems and take appropriate actions based on available information
• Organization skills and ability to plan and prioritize work to meet deadlines.
• Proficiency in the use of computer hardware, software and databases such as Word processing software, MS office, TrackWise, Empower, or other applicable to analytical instrumentation software.
• Demonstrate accuracy and thoroughness of work and adhere to high quality standards related to cGMPs.

• Experience
  • At least five (5) years experience in pharmaceutical laboratory (B.S)
  • At least two (2) years laboratory experience (M.S.)