Formulation Scientist

Formulation Scientist Axenza Pharma Newtown, PA Job Details Full-time $45,000 - $75,000 a year 14 hours ago Benefits Paid time off Qualifications Research design Dissolution testing Stability testing Gas chromatography Biochemistry GLP Master's degree in chemistry Developing new product formulations Stability studies in drug product development Biochemical research Technical documentation ISO standards High-performance liquid chromatographs Master's degree in Biochemistry Laboratory experiments GMP Formulation chemistry Technical report writing Master's degree Bachelor's degree Doctor of Philosophy Pharmaceutical analysis Laboratory compliance Quality control Bachelor's degree in pharmaceutical sciences Experimental design Intellectual property law Chemistry, manufacturing & controls Quality standards in production Chemistry Regulatory submissions Manufacturing Senior level Bachelor's degree in biochemistry Research & development Spectroscopic techniques Bachelor's degree in chemistry FDA regulations Drug formulation Method validation Manufacturing scale-up in drug product development Full Job Description Job Overview We are seeking a dynamic and innovative Formulation Scientist to join our vibrant research and development team. In this role, you will lead the design, development, and optimization of pharmaceutical formulations, ensuring they meet rigorous quality standards and regulatory requirements. Your expertise will drive the creation of safe, effective, and scalable drug products that make a meaningful difference in patients' lives. This position offers an exciting opportunity to contribute to cutting-edge product development within a collaborative and fast-paced environment. Responsibilities Develop and optimize formulation strategies for new drug candidates, utilizing principles of chemistry, biochemistry, and pharmaceutical sciences. Conduct experiments related to organic chemistry, analytical chemistry, spectroscopy, and chromatography techniques such as high-performance liquid chromatography (HPLC) to analyze product stability and purity. Design and execute laboratory experiments following Good Laboratory Practice (GLP) standards to ensure data integrity and reproducibility. Collaborate with manufacturing teams to scale up formulations from laboratory to production scale while maintaining compliance with CGMP (Current Good Manufacturing Practices) and

ISO 9001

standards. Evaluate raw materials, excipients, and process parameters to improve product stability, bioavailability, and manufacturability. Prepare detailed technical reports, documentation for regulatory submissions, and intellectual property filings in accordance with FDA regulations and intellectual property law. Stay current with industry trends in drug discovery, clinical trials, and regulatory guidelines to ensure formulations meet all safety and efficacy standards. Experience Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry or related field; PhD preferred. Proven laboratory experience in pharmaceutical or industrial laboratories with a focus on formulation development. Hands-on experience with analytical techniques such as spectroscopy (UV-Vis, IR), chromatography (HPLC, GC), and other relevant methods. Familiarity with drug discovery processes, clinical trial phases, and regulatory requirements including FDA regulations and CGMP guidelines. Knowledge of molecular biology techniques is advantageous for projects involving biologics or biopharmaceuticals. Demonstrated ability to design experiments systematically while adhering to GLP standards. Strong understanding of quality control processes within

ISO 9001

frameworks and manufacturing environments. Join us to be part of a passionate team dedicated to pioneering innovative solutions that improve health outcomes worldwide!

Pay:

$45,000.00 - $75,000.00 per year

Benefits:

Paid time off

Work Location:

In person