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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, Weight Verification Testing, Identification Testing of products by HPLC, FTIR and UV-VIS spectrophotometer, and Physical Testing (Appearance, Flavor, Odor, Basis Weight and Overflow Capacity) for solid dosage and liquid dosage finished product release and raw materials testing. Performs intermediate chemistry and physical testing as needed: USP/EP Residue on Ignition, Acidity/Alkalinity, and specified compounds, Light transmission by UV-VIS spectrophotometer, HPLC Testing (Assay and Content Uniformity), Dissolution Testing (with end by UV-VIS or HPLC), and Gas Chromatograph Testing (GC) Performs advanced chemistry and physical testing to support the commercial and clinical stability and release testing of raw materials and drug products using the following techniques in accordance with GMP, GLP and company testing methods:

-HPLC Related Compounds/Impurities Testing

-Cleaning Verifications

-Cleaning Validation Method Transfer and Recovery Studies

-Advanced Pharmacoepial Testing (Manual Titrations, Impurities, etc)

-Limit Tests

-Ion Chromatography (IC) Testing

-Gas Chromatograph Mass Spectrophotometer Testing (GC-MS)

Ability to successfully interpret and execute technically challenging methodology with minimal supervision. Plans and organizes work with minimal supervision and communicates testing results to Laboratory Management as needed. Write calibration OOS investigations including RIT's and potential product impact assessments. Development and implementation of corrective and preventative actions. Actively participates in and method transfer and/or method validation activities between facilities within the organization or between organizations by preparing and executing method transfer protocols and reports for any of the above analytical testing listed. Manages the project between the customer/PCI. Recommends options for project approaches/experiments. Write, review and revise work instructions and test methods Write, review and participate in deviation investigations, Out of Specification investigations, Out of Trend investigations, and Corrective Actions/Preventative Actions as needed. Work with internal and external customers to resolve issues associated with deviations, Out of Specification investigations and Out of Trend investigations Participates in FTIR, UV-VIS, Karl Fischer, Dissolution, GC, GC-MS, IC and HPLC calibration, maintenance and troubleshooting as required Arranges to order lab materials, including chemicals, solvents, consumable supplies, etc. Perform daily verification checks of lab equipment (FTIR, UV-VIS, analytical balances and pH meters) Reviews interprets and analyzes data for technical, quality and compliance to protocols, methods, SOP’s, client criteria, Good Manufacturing Practices (GMP) and/or Good Laboratory Practice (GLP). Documents experiments, results and findings in the laboratory notebook and LIMS system. Review and approval of technical data is required Development of validated Microsoft Excel and Chromatography Data System (Chromeleon) templates to reduce manual activities Analyze data using statistical tools such as Chromatography Data System (Chromeleon) and Microsoft Excel Participate in customer audits by assisting and answering questions. Prepares, discusses and presents analytical data to internal and external customers and auditors. Providing technical advice to internal and external customers. Gathers data for APR’s and authors APR reports for various customers Initiation/management of change controls Participation in the introduction of new equipment, including authoring, execution and review of URS/IQ/OQ/PQ documentation Review of customer updated methods and the initiation of any transfer/validation activities in accordance with defined procedures Generate quotations for projects in area of technical expertise. Assists with determining appropriate pricing for various projects Hosting and participation in weekly project management calls with PCI customers Co-ordinate and schedule service engineers to ensure that equipment down time is kept to a minimum. Technical data review of service engineer preventative maintenance and calibration documents.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.

• Statistical and Advanced Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

• High standard of report writing.

Preferred:

• Ability to display a willingness to make decisions.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to adapt to changing work environments.
• Ability to exhibit sound and accurate judgement.
• Ability to take ownership of issues and works towards resolution.