Senior Pharmaceutical Scientist

at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States

Job Description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
The Senior Pharmaceutical Chemist position acts as a leader of the Quality Control Analytical team executing Stability and Release testing for the Laboratory and supports ongoing and new Laboratory projects. This colleague will lead and support GMP analytical testing activities. The primary function of this position is to perform elementary, intermediate and advanced analytical and physical testing of pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology in accordance with regulatory standards with a high level of accuracy and minimal personal error. The ability to successfully interpret and execute technically challenging methodology is required. In addition, the Senior Pharmaceutical Chemist will have the ability to independently perform testing and analyze data and assist others with analyzing data. Analytical testing is performed using equipment such as FTIR, Karl Fischer, UV-VIS, HPLC, Dissolution, GC, GC-MS and IC with calibration, maintenance and troubleshooting of this equipment. This position will require training of analysts in techniques for which competency has been demonstrated. In addition, the Senior Pharmaceutical Chemist will participate in authoring/review of OOS investigations and assist in the determination of root cause. Review and approval of technical data and calibration documents is required. This role may also be customer facing with involvement in project management, method transfers, method validations, or weekly internal/external customer contact. Co-ordination and scheduling service engineers to ensure that equipment down time is kept to a minimum. There are no supervisory responsibilities.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

GENERAL RESPONSIBILITIES

Receipt and logging of samples into LIMS including setting up new product/test and specifications Works in an efficient manner to a high level of accuracy with minimal personal error Generation and documentation of raw data in accordance with cGMP and ALCOA principles Collect, process and analyze data Knowledge of USP/EP general chapters and ICH Guidelines which pertain to job function Training of other analysts in techniques for which expertise has been demonstrated. Scientific mentoring and coaching of level I and II Pharmaceutical Chemists On time completion of assigned training in ComplianceWire Participate in internal Health and Safety audits including developing actions and follow up Participates in internal, customer and regulatory audits Retains product upon completion of testing and retaining of raw data upon issuance of analytical report/CoA Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence Ensure that all waste materials/solvents are disposed of in a safe and timely manner. Leads/participates in implementation and execution of continuous improvement activities Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory This position may require extra hours and/or weekend work. This position will require the individual to be on an on-call rotation schedule for off shifts, weekends and holidays in case of emergencies in the stability chambers Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Performs other duties as assigned by Manager/Supervisor.

SPECIFIC RESPONSIBILITIES

Performs elementary chemical and physical testing as needed: Wet Chemistry (pH and Conductivity Testing), United States Pharmacoepia (USP)/European Pharmacoepia (EP) Monograph ID Testing, Loss on Drying Testing, Water Activity Testing, Disintegration Testing, Friability Testing,... For full info follow application link.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.