Summary:

Supports the development and validation of methods to test new products manufactured at the site. Performs testing of experimental, confirmation and registration lots, stabilities and new supplier certifications. Participates in the transfer of analytical technology to the commercial laboratories with attention to details. 

Primary Functions:

1. Receives and logs in samples, review analytical data and prepare certificate of analysis.
2. Performs non-conventional testing of solid dosage forms, capsules and others forms under the supervision of the PD Analytical Development Scientist, such as: force degradation, tablet scoring, solubility, method validation, method development analysis, bioequivalence dissolution analysis 3 biological medias, among others.
3. Performs tests for API, raw materials, in-process samples, research samples, finish product and stabilities following analytical protocol specifications, procedures, and/or instructions as applicable.
4. Revises SOPs and complete daily schedule.
5. Keeps track of the reagents, standards and supplies inventory in the Product Development laboratory, generate the purchase requisition request as needed.
6. Assures that files and records are maintained up to date.
7. Attends development meetings as needed.
8. Supports EHS program to assure compliance with safety policies.
9. Performs laboratory housekeeping always.
10. Documents on a timely manner in the corresponding laboratory logbooks and laboratory notebooks all the information regarding the testing activities.
11. Performs any other duties as assigned.
12. Write/assist in laboratory protocols deviation report.
13. Handle controlled substances.
14. Assists in data verification and informs supervisor if any discrepancy found.
15. Enters tests results in the database and informs supervisor if any discrepancy is found.

Secondary Functions:

1. Assists in or carries out work of an experimental nature while under limited supervision.
2. Works with instruments of an advanced and/or sophisticated nature and performs troubleshooting work when required.
3. Keeps records and files up to date and assures that information is available at all times.
4. Ensures that any waste (hazardous, non-hazardous or special waste) generated as part of his/her responsibilities are handled in compliance with applicable environmental regulations and in accordance to establish SO P's for handling waste.

Education Requirement:

• Bachelor's Degree in Chemistry.
• Two to four years or more of experience in a cGMP regulated analytical laboratory.

Experience Requirement:

• Experience in method validation ( execution of protocols and reports) and analytical technology transfer.
• Knowledge in FDA, ICH, GMP and USP requirements for method validation and transfer.
• Computer literate
• Excellent communication skills in English and Spanish.

Work Methodology:

• 100% On-site
• 6 months (1st Contract)
• Administrative Shift (available to work flexible shifts, including weekends and overtime, as required).
• Temporary Contract