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The Pharmaceutical Chemist II position is an integral member of the Quality Control Analytical team supporting Stability and Release testing for the Laboratory. This colleague will support GMP analytical testing activities. The primary function of this position is to perform elementary and intermediate 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 Pharmaceutical Chemist II will have the ability to independently perform testing and analyze data. Analytical testing is performed using equipment such as FTIR, Karl Fischer, UV-VIS, HPLC, Dissolution and GC 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 Pharmaceutical Chemist II will participate in OOS investigations and assist in the determination of root cause. 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 On time completion of assigned training in ComplianceWire Participate in internal Health and Safety audits including developing actions and follow up 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 Plays a key role in creating and maintaining an atmosphere of teamwork throughout the laboratory This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Performs other duties as assigned by Laboratory Management

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 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:

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-Light Transmission by UV-VIS Spectrophotometer

-HPLC Testing (Assay and Content Uniformity Methods)

-Dissolution Testing (with end by UV-VIS or HPLC)

-Gas Chromatograph Testing (GC)

Plans and organizes work with periodic supervision and communicates testing results to Laboratory Management as needed Ability to interpret different customer method requirements with minimal supervision Write calibration OOS investigations including RIT's and potential product impact assessments 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 Write/Revise Work Instructions/Test Methods Participate in deviation investigations, Out of Specification investigations, Out of Trend investigations, and Corrective Actions/Preventative Actions as needed. Participates in FTIR, UV-VIS, Karl Fischer, Dissolution, GC 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 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 Scientist should be self-motivated, organized, capable of working independently and in a collaborative environment

Ability to prioritize and multi-task concurrent project demands, while maintaining exceptional attention to detail as well

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: Under a 1/4 of the day.
• Move, Traverse: 3/4 of the day and up.
• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
• Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): 3/4 of the day and up.
• Communicate or exchange information: From 1/2 to 3/4 of the day.
• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

between 1/4 and 1/2 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• PAPR Gowning may be required for to of the day dependent on the nature of some compounds.
• Fumes or airborne particles for 1/4 to 1/2 of the day.
• Toxic or caustic chemicals for 1/4 to 1/2 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up.
• Work near moving mechanical parts for up to 1/4 of the day.

The noise level in the work environment is typically, moderate.

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 5-10 years related experience and/or training.

• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of 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 demonstrate attention to detail.
• Ability to adapt to a changing work environment.
• Ability to hold oneself in a professional manner.
• Ability to identify and resolve problems in a timely manner.
• Ability to exhibit sound and accurate judgement
• Ability to demonstrate excellent time management skills
• Ability to take ownership of issues and works towards resolution

Join us and be part of building the bridge between life changing therapies and patients.