Analytical Scientist I

Aprecia Pharmaceuticals, LLC

  • Mason, OH
  • Permanent
  • Full-time
  • 1 day ago
General Purpose of Position: This position is responsible for laboratory activities associated with analytical testing, analytical method development, and method validation. Interfaces with Product Development, Manufacturing and Quality Assurance functions to proactively fulfill analytical laboratory responsibilities and to perform QC analytical testing, leverage analytical sciences to characterize formulations under development and to provide analytical testing for the development of novel 3DP (three-dimensional printing) manufacturing processes. In addition, this position is responsible for writing protocols, development reports, SOPs, (standard operating procedures); training others on analytical techniques; being familiar with USP/NF (United States Pharmacopeia/National Formulary) analytical procedures; and maintaining an understanding of cGMP’s (current Good Manufacturing Practices) and ICH (International Conference on Harmonization) guidelines.Primary Duties and Responsibilities (Essential Functions):
Duties/Responsibilities
1 Perform GMP analytical testing, method development and validation of analytical methods utilizing a variety of analytical techniques including HPLC-UV (High Performance Liquid Chromatography – Ultra Violet Detector), UV-Vis (Ultra Violet-Visible) Spectroscopy, HPLC/MS/MS, GC, analyses using different separation mechanisms and Dissolution (Apparatus I and II)
2 Perform and monitor stability testing of drug products. Provide statistical analysis of the data when applicable.
3 Perform analytical testing in support of Product Development. Conduct data analysis and assess consistency/accuracy for development projects.
4 Perform technical problem-solving utilizing a background of wet chemical and instrumental methods of
analysis.
5 Transfer analytical methods and procedures between testing sites when applicable and provide guidance and technical support to laboratory staff for implementation.
6 Train and mentor less-experienced members of the QC/AD Department as needed.
7 Author analytical methods, SOPs, and technical protocols and reports
8 Adhere to all company compliance and safety procedures
9 Maintain a clean and safe workplace dailyReporting to this Position:
No direct reportsTravel:
Occasional travel may be required.Work Shift:
This position works days.Knowledge, Skills and Abilities:
practices), USP and related ICH (International Conference for Harmonization)/FDA guidance documents is required * Excellent oral and written communication, interpersonal, teamwork, and organizational skills
  • Experienced with current analytical techniques (e.g., separation technology, spectroscopy, wet chemistry, dissolution testing, etc.) including
practices * Manage time effectively in a fast-paced, goal-oriented environment
to objectively assess laboratory results and make evidence-based recommendations on testing and other laboratory operations required.Education and Experience:
  • M.S./Ph.D. in Chemistry or other related discipline and at least 1-2 years of relevant experience in the pharmaceutical industry preferred.
  • Hands-on experience and expertise in HPLC (reverse phase, ion exchange, ion pair, HILIC (hydrophilic interaction liquid chromatography), HPLC/MS/MS, Dissolution (USP Apparatus I and II), pH meter, Analytical Balances and wet chemistry desired.
  • Experience with Agilent ChemStation and/or Waters Empower chromatography data acquisition software is required
  • Ability to design, follow, and review experimental protocols, scientific methods, and departmental procedures is required
  • Ability to organize and interpret scientific data is required
  • Prior experience training and mentoring less experienced staff is desired
Physical Demands and Work Environment:
  • Ability to stand for extended periods of time performing laboratory testing and other operations
  • Ability to sit for extended periods of time to document and analyze testing results
  • Occasional odd body positioning – including kneeling and bending -- to manipulate and use laboratory equipment
  • Good manual dexterity to operate computer, general office, and laboratory equipment and to document laboratory testing results
  • Fine motor skills to manage more delicate laboratory testing
  • Good eyesight to read technical and instructional materials
  • Ability to wear appropriate PPE (personal protective equipment) such as gloves, safety glasses, lab coat, respirator as required for exposure to laboratory and pharmaceutical operations
  • Ability to perform light lifting (up to 20 pounds) to handle HPLC/Dissolution solvents and waste
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

Aprecia Pharmaceuticals, LLC