Job Description

Job Location: Miramar, FL 33025
Salary Range: $85,000.00 - $90,000.00 Salary/year
Job Shift: AnyJob

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, SOP’s, 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

QualificationsJob Requirements
- Education
- - Bachelor’s degree (B.S.) in chemistry or related field
- - Master’s 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.)