Scientist, Analytical Development The Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping. The incumbent must be able to develop and implement methods that meet project needs. The position is responsible for conducting analytical development studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.
Salary Range:
$70,000-75,000. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Responsibilities:
Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc.
Performs validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory.
Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation.
Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team.
Support Laboratory operation for instrument qualification.
Ensures all technologies needed are available for project completion.
Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing.
Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems.
Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
Requires an eye for detail and repetitive precision in lab work and documentation.
Requirements:
BS degree in Chemistry or related degree with 3+ years of related experience Must possess skills in chromatography, such as HPLC, GC, TLC, IC and/or skills in handling wet chemistry and operating basic lab instruments, such as pH, Osmometer, Colorimeter, HIAC, particle size analyzers, FTIR, Karl Fischer methods 1a and 1c, UV/Vis, specific rotation, residue on ignition, manual titrations, loss on drying, etc. Must have skills in designing and executing experiments using different lab instruments and techniques. Must have knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems. Must be familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations. Strong verbal and written communication skills. Strong problem-solving skills. Strong interpersonal skills. The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment. We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
