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

We are PCI.

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.

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

We are PCI.

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.

The Pharmaceutical Scientist 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 Scientist 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 Scientist II will participate in OOS investigations and assist in the determination of root cause. There are no supervisory responsibilities.

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

Required Qualifications

• 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

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

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.