The RoleThe Analytical Scientist II is responsible for analytical method development, validation, and transfer activities under the supervision of the Senior Group Leader. This includes formulation development such as material characterization, API/raw materials sampling, cleaning verification, and technical writing. Main Tasks and Responsibilities Operates and troubleshoots the following instruments and equipment to test and evaluate pharmaceutical samples HPLC/UPLC, dissolution apparatus, Karl-Fischer water content titrator, GC, FTIR, UV, and any other instruments as directedFollows analytical testing methods, compendial methods, experimental procedures, and SOPsConducts release and stability testing for drug product in the QC laboratories Documents test results in laboratory notebook, in real time, and communicates status of test results to supervisor Peer reviews laboratory notebooks for technical details Maintains control of all project- related pharmaceutical samples submitted to the laboratory as they can contain potent and/or hazardous componentsPerforms cleaning and housekeeping duties to ensure the laboratory is continuously maintained in a safe and orderly conditionCollaborates with supervisor regarding sample preparation, instrument performance, data acquisition, and analysis Supports department LIRs, Deviations, CAPAs, Change Controls and SOP updates as neededTrains on all SOPs and company procedures and remains current with training curriculumThe CandidateKnowledge: The factual and procedural information required to perform the roleBachelor’s degree in Chemistry or other related field of study with 3 years’ experience in an Industrial Pharmaceutical LaboratoryMaster’s degree in Chemistry or other related field of study with 1 years’ experience in an Industrial Pharmaceutical Laboratory Ph.D. with 0-2 years’ experience in an Industrial Pharmaceutical Laboratory In lieu of a of a Ph.D. degree in Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field, or foreign degree equivalent plus two (2) years of experience in the pharmaceutical industry, the employer will accept a Bachelor’s degree in the same fields, or foreign degree equivalent plus three (3) years of experience in the pharmaceutical industryKnowledge of federal and state regulations and guidelines including FDA, EPA, OSHA, and DEA Knowledge of all company and site policies and procedures Knowledge of commercial laboratory safety procedures, precautionary laboratory measures, and GMP Manufacturing proceduresSkills: The effective use of knowledge and abilities in performance. Proficiency in Microsoft Office requiredProficiency in experiment documentation and basic laboratory skillsUse instruments, equipment, and technology safely and effectivelyAble to work in a hazardous environment with a high requirement to follow safety procedures Proficiency in HPLC and dissolution Proficiency with Chromatographic data systems (CDS) such as EmpowerAbilities: Innate traits or talents a person possessesGood communication skills with the ability to effectively document testing process and report information to supervisorGood time management skills with the ability to ensure accurate and timely data reportsGood writing skills with the ability to document and explain findingsGood analytical skills with the ability to understand and analyze data Commitment to continuous education to remain in current profession and industry trends, make suggestions for new improvements, and learn new skills, procedures, and aspects of formulation and development