Laboratory Scientist - Product Development
Laboratory Scientist - Product Development
Posted on :
23-07-2025
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1 Vacancy
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Job Description
Summary:
Support and/or development and validation of methods to test new products manufactured at the site. Design testing of experimental confirmation and registration lots stabilities and new supplier certifications. Participate and/or develop the transfer of analytical technology to the commercial laboratories.Primary Functions:
- Designs experiments to generate analytical methods suitable to support formulation development.
- Develops and validates cleaning and analytical methods.
- Performs compendial methods evaluation and prepares verification protocols and reports.
- Evaluates the data generated by laboratory technologist and or laboratory analysts and trends.
- Assures all the information regarding to the testing activities is documented on a timely manner in the corresponding laboratory logbooks and laboratory notebooks.
- Prepares API Raw Materials and Finished Product Specifications and Analytical Methods.
- Evaluates Technical Transfer Packages and prepares Analytical Method Transfer Protocols and Reports. Evaluates raw data perform troubleshooting of analytical methods and oversee laboratory work performed by laboratory analyst and technologists.
- Performs or supports laboratory investigations as required.
- Prepares progress reports and participate in Staff Meetings.
- Acts as a backup contact for the Analytical Development Manager.
- Revises SOPs and keeps track of the weekly schedule.
- Provides training to laboratory analyst and laboratory technologist as need.
- Assures that files and records are maintained up to date.
- Supports EHS program to assure compliance with safety policies.
- Interprets results obtained during method development and troubleshoot tests as needed.
- Ensures compliance with current pharmacopeia FDA and ICH guidelines.
- Updates specifications and test methods as needed.
- Provides scientific coaching to laboratory personnel such as training in specific analysis techniques protocol instructions and method development technics among others.
- Prepares laboratory deviation reports.
- Performs any other duties as assigned.
- Bachelors Degree in Chemistry (Analytical Organic or Pharmaceutical).
- Eight (8) years of related experience in analytical laboratory.
Experience Requirement:
- Experience in method validation (preparation of protocols and reports) analytical technology transfer and cleaning validation are required for pharmaceutical small molecules.
- Experience in a cGMP regulated analytical laboratory.
- Knowledge in FDA ICH and USP requirements.
- Hands on experience in analytical method validations.
- Proficient in the use of LIMS system.
- Exercise attention to detail.
- Strong technical writing skills.
- Capable to read and interpret correctly scientific and technical literature.
- Excellent communication skills in English and Spanish.
- 100% On-site
- 6 months (1st Contract)
- Administrative Shift (available to work flexible shifts including weekends and overtime as required).
- Temporary Contract
Employment Type
Full Time
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