Senior Scientist Analytical Chemist
About The Position
Ability to work in a GLP or GMP environment with appropriate documentation and safety practice. Independently develop, utilize, and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC, UPLC), USP/EP dissolution testing, mass spectrometry, vibrational spectroscopy, gas chromatography, and/or Karl Fischer titration to characterize drug products, APIs, intermediates, and impurities in support of formulation. Develop dissolution methodologies that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure. Develop and execute studies to ascertain degradation mechanisms in a variety of environmental, formulation, and stress conditions. Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies. Develop assay/purity methods and assessment of method robustness/ruggedness Develop and execute method validation protocols. Transfer analytical methods to other laboratories and remote sites. Hands-on generation of data in support of accelerated and registration stability studies. Mentor junior chemists by guiding analytical best practices, experimental design, and data interpretation.
Requirements
- Bachelor’s degree in chemistry or other related degree concentration with 5 years of experience or a Master’s degree with 2-4 years of experience.
- At least three years of experience in product development and analytical chemistry
- Strong computer, scientific, and organizational skills
- Excellent communication (oral and written) and attention to detail
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Responsibilities
- Work in a GLP or GMP environment with appropriate documentation and safety practice.
- Independently develop, utilize, and validate test methods containing advanced analytical techniques such as liquid chromatography (HPLC, UPLC), USP/EP dissolution testing, mass spectrometry, vibrational spectroscopy, gas chromatography, and/or Karl Fischer titration to characterize drug products, APIs, intermediates, and impurities in support of formulation.
- Develop dissolution methodologies that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
- Develop and execute studies to ascertain degradation mechanisms in a variety of environmental, formulation, and stress conditions.
- Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies.
- Develop assay/purity methods and assessment of method robustness/ruggedness
- Develop and execute method validation protocols.
- Transfer analytical methods to other laboratories and remote sites.
- Hands-on generation of data in support of accelerated and registration stability studies.
- Mentor junior chemists by guiding analytical best practices, experimental design, and data interpretation.
Benefits
- Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
