Job Description

Associate Scientist II

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a multiple direct hire opportunities to work as an Associate Scientist II located near the Ft. Lauderdale/Miami, FL area .

Shift: Monday-Friday, 2nd shift, 4pm-12am

Function: Chemistry, Manufacturing, and Control (CMC)

Relocation offered

Salary:

• Associate Scientist II : $65,000-85,000 plus 10% target bonus

Job Summary:

We are seeking a highly motivated Scientist (multiple levels) to join our Analytical Sciences team. The successful candidate will be responsible for conducting laboratory activities related to the development, optimization, transfer, and validation of analytical methods for drug products. The role involves using a variety of analytical techniques, such as liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP). The Scientist will also be responsible for conducting physico-chemical characterization studies, performing data analysis, and drafting scientific documents to meet global regulatory standards, including those from the US FDA and EMA.

Key Responsibilities:

• Independently conduct standard and advanced laboratory activities, including liquid chromatography (LC), spectroscopy, and aerosol performance characterization studies for OINDPs.
• Perform physico-chemical and aerosol analytical characterization of OINDPs, including the evaluation and selection of raw materials such as APIs, excipients, and packaging materials.
• Develop, verify, optimize, transfer, and validate analytical methods in accordance with cGMPs, EH&S guidelines, and other regulatory requirements.
• Conduct in-depth data analysis using advanced statistical tools and techniques, identifying trends and making data-driven recommendations.
• Draft protocols, reports, SOPs, and regulatory submission documents regularly.
• Present data analysis and recommendations to senior management and communicate findings effectively with team members and external stakeholders.
• Troubleshoot technical issues and implement solutions in a timely manner.
• Ensure compliance with safety rules and corporate guidelines in all lab activities.

Qualifications:

• Associate Scientist II: BSc in Chemistry, Pharmacy, or related fields with at least 3 years of experience in Pharmaceutical R&D, or MSc in Chemistry, Pharmacy, or related fields with 2+years of experience in Pharmaceutical R&D required.
• Extensive knowledge and hands-on experience with chromatography (HPLC, GC), spectroscopy (UV, FTIR), and other analytical techniques.
• Must have at least 3 years of experience in method development and validation using HPLC and Empower software for pharmaceutical products
• Proven experience in analytical method development, verification, and validation.
• Strong technical writing skills with the ability to draft high-quality documents, including protocols, reports, and regulatory submission sections.
• Experience with orally inhaled and nasal drug products (DPI, MDI, or nasal drug products) is a plus.
• Familiarity with USP methodologies, ICH guidelines, FDA, and cGMP regulations.
• Strong English language communication skills, both written and oral.

This position offers competitive salary and benefits, and the opportunity to contribute to cutting-edge pharmaceutical research and development.

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