Job SummaryThe incumbent is responsible for execution of chemistry or microbiology related protocols for instrument qualification, instrument software validation, test method validation, test method verification and test method transfer. Executed protocols shall support implementation of method of analysis for API, raw material, in-process, finished product and stability samples in the Quality Control Chemistry and Microbiology laboratory.* Reports to QC Principal Scientist* Duties are of routine nature following established standard operating procedures. Problem recognition ability is needed. Non-critical functions, and to a lesser degree some critical functions, utilize independent action and decision making with follow-up reporting to supervision.* Supervisor directly responsible for training, assignment of duties and review/approval of work. Direction, training and some day-to-day supervision may also come from a Lead Scientist.* Mentors Associate Scientists and Technicians.* Effectively communicates work and results both orally and in writingResponsibilitiesPRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT* Develops new Standard Operating Procedures for laboratory test procedures. Maintains SOPs to assure constant compliance with corporate and regulatory requirements.* Drug product testing experience consisting of Standard Solutions, and ready to administer prefilled syringes (containing controlled substances, Biosimilars, and various injectable products).* Monitors and tracks laboratory test results.* Performs training on laboratory instrumentation for lower level positions and mentors them to further their development.* Schedules, initiates, coordinates, performs routine testing of raw material, in-process, finished product and stability samples, as needed.* Informs supervisory personnel of all relevant events impacting the operations and performance of the department discrepancies and out of limit conditions. Investigates and identifies additional testing to be performed to resolve these issues in a timely manner.* Maintains knowledge of current cGMPs and GLPs. Maintains compliance with current compendial methods.* Provides instrument/software qualification, method validation, method verification and method transfer test support.* Follows safety requirements and maintains good housekeeping of lab areas.* Reviews work performed by department staff for accuracy, completeness and conformance to specifications.* Supports new product development related testing as directed.* Prepares and performs routine analysis by HPLC, GC, AA/ICP or other analytical instrumentation including assay and impurity methods, collects, processes and calculates generated data.* Works with Principal Scientists, Lead Scientists, Supervisors, and/or Managers in development and validation of new laboratory test methods.* Develops protocols for laboratory methods and production process validations. Participates in performing validation work. Performs studies and validations required to support Product Development.* Coordinates the assembling of supplemental information for regulatory submissions.* Makes and implements timely decisions within the established authority and consistent with company policies, procedures and practices.* Performs protocol discrepancy reports as acceptance criteria are not met with associated protocols.* Performs training for QC staff on new instrumentation or new analytical or microbiology related test methods.* Assumes additional duties and responsibilities as assigned by management.REQUIREMENTS* If Chemistry Related Discipline: B.S. in Chemistry or related field with 3-5 years of experience preferred. Background in analysis on HPLC and other analytical techniques (UPLC, LCMS, Gas Chromatography, Gas Chromatography with Head Space, Coagulation Analyzer, Atomic Absorption Spectroscopy, Automated Pipetting Platform, BET Analyzer, TOC Analyzer, NIR, FT-NIR, RAMAN, MT LabX, Waters Empower 3) desirable.* If Biochemistry Related Discipline: B.S in Biochemistry, Biology or related field with 3-5 years of experience preferred. Background in analysis on Size Exclusion-HPLC and other analytical techniques (UPLC, LCMS, Gas Chromatography, Gas Chromatography with Head Space, Tissue Culture, Capillary Electrophoresis, Solid Phase Extraction, SDS-PAGE, ELISA, Coagulation Analyzer, Atomic Absorption Spectroscopy, Automated Pipetting Platform, NIR, FT-NIR, RAMAN, MT LabX, Waters Empower 3) desirable.* If Microbiology Related Discipline: B.S. in Microbiology or related field with 3-5 years of experience preferred. Background in analysis on Microbiology Instrumentation/Equipment and other microbiology related techniques (LAL Automated Pipetting Platform, BET Analyzer, TOC Analyzer, Particulate Matter Analyzer, MT LabX, Isolator/Biosafety Hood Sterility Development, Bioburden Enhancement/Inhibitory Techniques,) desirable. Excellent verbal and written communication skills are essential.IND-1#GDAdditional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.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, disabilities, or protected veteran status.
Location/Region: Wilson, NC (27893)