Ability to work in a GLP or GMP environment with appropriate documentation and safety practices.
Support formulation development through hands-on generation of accurate and precise analytical chemistry data using routine laboratory techniques such as liquid chromatography (HPLC, UPLC), NMR (liquid), mass spectrometry, vibrational spectroscopy, USP/EP dissolution testing, Karl Fischer titration
Development of dissolution methodology that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
Development and execution of studies to ascertain degradation mechanisms in the solution and solid state.
Assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile. This would involve DoEs and accelerated stability studies.
Development of assay/purity methods and assessment of method robustness/ruggedness
Development and execution of method validation protocols.
Transfer of analytical methods to other laboratories and remote sites.
Hands-on generation of data in support of accelerated and registration stability studies.
Bachelor’s degree in science or other related degree concentration, or equivalent directly-related experience
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
At least one year experience in product development analytical chemistry