Under general supervision, performs laboratory analyses in the testing of raw materials, finished products, research and stability samples. Will prepare complex transdermal patch matrix formulations, as well as hydrogels, dissolvable films and topical gel formulations for testing and critical evaluation. Performs maintenance and calibration of analytical instruments and prepares standard and sample solutions. Carries out laboratory work to support product development, formulations preparation and testing, exhibit batch testing, and performance of non-routine testing such as, method comparisons, and laboratory investigations. May provide direction and training to junior level staff and perform intermediate technical duties. Essential functions include: - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Operates general analytical instruments during raw materials, finished products, and research material testing such as HPLC, UPLC and UV/IR, as required.
- Will set up, perform, and take samples for cadaver skin flux studies to evaluate performance of new formulations as well as competitor products.
- Perform assays of skin flux samples on HPLC, process data and assay drug amount in finished systems as needed.
- Under minimal supervision, plan formulations and prepare various adhesive matrix active and placebo TDS, topical gels and casting solutions.
- Prepare and analyze complex multiple component, active hydrogel materials.
- Prepares cast film laminates from various active and placebo casting solutions, hydrogels, as well as buccal and sublingual dissolvable films per specification including preparation of stability samples.
- Performs wet chemistry tests on samples such as LOD, pH, water content, and titration; prepares standard and sample solutions as required by test methods; and performs all necessary calculations associated with the test analyses.
- Prepares, transcribes and records documentation such as report sheets, Excel spreadsheets, and laboratory notebooks as required by Standard Operating Procedures (SOPs).
- Cleans, maintains and calibrates laboratory equipment to ensure compliance with cGLP and cGMP.
- Designs and carries out experimental plans to investigate performance or stability issues with various transdermal formulations.
- Performs accelerated and room temperature stability studies for new formulations/dosage forms.
- Assists with laboratory investigations, method development and validations as needed.
- Performs physical testing such as shear, adhesion to steel and tack on cast film laminates and extensive microscopic examinations of both research and stability transdermal systems.
- Meets project deadlines and performance standards as assigned.
- Complies with all Company policies and procedures, including safety rules and regulations.
Two (2) years related laboratory experience, or an equivalent combination of education and experience.
- Pertinent SOP's related to pharmaceutical laboratory testing, analyses and documentation.
- UV/IR, HPLC, UPLC and TLC instruments operation methods and techniques.
- Business, scientific and personal computer hardware and software applications.
- Business English usage, spelling, grammar and punctuation.
- Wet Chemistry and Chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures.
- FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
- Spectroscopic and chromatographic operation, techniques and systems.
- Dissolution testing.NOTE: No relocation benefit available for this position. ****
Bachelor's Degree in Science or related science field from an accredited college or university.