Cambrex
Overview
Principal Scientist 2 - ARD will independently: conduct development and optimization for methods that have no starting point for intermediates and final products. Develop and optimize robust analytical methods for final product that are validatable. Maintain laboratory notebook and perform data review. Maintain lab instrumentation. Conduct method development and optimization on LC/MS and/or GC/MS. Troubleshoot instrument issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances. Perform laboratory investigations and non-routine project work including QC issues. Author analytical procedures, protocols, and reports. Act as Analytical lead for internal projects including responsibility for all Analytical aspects of the project from development through technical support of QC for final product release. With minimal support, lead larger scope projects including cross-site projects within Cambrex.
Responsibilities
Develop and optimize analytical methods for intermediates and final product.
Maintain and review notebook and data entries.
Write analytical procedures, protocols, reports and similar documents.
Write SOPs, CAPAs, and similar documents.
Perform laboratory investigations.
Lead laboratory investigations for Analytical and QC.
Lead larger-scope projects.
Train and mentor laboratory colleagues.
Maintain equipment
This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Qualifications / Skills Analytical Chemistry Knowledge:
Strong understanding of advanced theories in Analytical Chemistry and method development
Cross Discipline Knowledge:
Higher level of understanding of the principles of cross-functional departments, including organic chemistry and engineering
GMP/Regulatory Knowledge:
Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions and help them develop their clinical package
Instrumentation:
Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)
Communication:
Excellent written and oral communication skills, often leading technical calls with clients
Problem Solving:
Demonstrated ability to perform root cause analysis and solve problems
Time Management:
Very good organizational skills and time management. Able to work on several key items at once including two or more medium complexity projects at once
Leadership:
Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up
Technical Documentation and Review:
Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOPs
External Influence:
Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives
Industry Credibility and Rapport:
Demonstrated reputation as a leader within the Cambrex Analytical community. Good publication record, where possible, and strong contributions to the Cambrex portfolio
Operational Excellence:
Demonstrated ability to participate and share leadership on local OE initiatives
Change Orientation:
Demonstrated contribution of input and ideas for larger Cambrex system level changes
Education, Experience & Licensing Requirements Ph.D. in Chemistry or related field with 8 years minimum experience or M.S. in Chemistry or related field with 12 years minimum experience or B.S. degree in Chemistry or related field with 16 years minimum experience in a laboratory environment.
Fundamental Understanding With Some Of The Following Analytical Technologies
Titrations (manual and automated)
Basic wet chemistry
HPLC, GC, GC/MS, FTIR, NMR, XRPD, laser diffraction particle size, TLC
Working knowledge of other analytical equipment common to the pharmaceutical industry
This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Safety and equal opportunity statements are provided by Cambrex in accordance with applicable law.
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Principal Scientist 2 - ARD will independently: conduct development and optimization for methods that have no starting point for intermediates and final products. Develop and optimize robust analytical methods for final product that are validatable. Maintain laboratory notebook and perform data review. Maintain lab instrumentation. Conduct method development and optimization on LC/MS and/or GC/MS. Troubleshoot instrument issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing. Ensure compliance with applicable Company SOPs and regulatory guidances. Perform laboratory investigations and non-routine project work including QC issues. Author analytical procedures, protocols, and reports. Act as Analytical lead for internal projects including responsibility for all Analytical aspects of the project from development through technical support of QC for final product release. With minimal support, lead larger scope projects including cross-site projects within Cambrex.
Responsibilities
Develop and optimize analytical methods for intermediates and final product.
Maintain and review notebook and data entries.
Write analytical procedures, protocols, reports and similar documents.
Write SOPs, CAPAs, and similar documents.
Perform laboratory investigations.
Lead laboratory investigations for Analytical and QC.
Lead larger-scope projects.
Train and mentor laboratory colleagues.
Maintain equipment
This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Qualifications / Skills Analytical Chemistry Knowledge:
Strong understanding of advanced theories in Analytical Chemistry and method development
Cross Discipline Knowledge:
Higher level of understanding of the principles of cross-functional departments, including organic chemistry and engineering
GMP/Regulatory Knowledge:
Strong understanding of the GMP landscape and fundamental understanding of the industrial regulatory landscape; Good understanding of site SOPs and regulatory CMC concerns and can answer client questions and help them develop their clinical package
Instrumentation:
Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)
Communication:
Excellent written and oral communication skills, often leading technical calls with clients
Problem Solving:
Demonstrated ability to perform root cause analysis and solve problems
Time Management:
Very good organizational skills and time management. Able to work on several key items at once including two or more medium complexity projects at once
Leadership:
Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up
Technical Documentation and Review:
Strong ability to generate key technical documents with minimal RFT issues and to review documents for others. Basic ability to write new SOPs
External Influence:
Strong demonstrated ability to independently steer client or technical teams; ability to redirect and point out scope change; good ability to work with site leadership team and steer local initiatives
Industry Credibility and Rapport:
Demonstrated reputation as a leader within the Cambrex Analytical community. Good publication record, where possible, and strong contributions to the Cambrex portfolio
Operational Excellence:
Demonstrated ability to participate and share leadership on local OE initiatives
Change Orientation:
Demonstrated contribution of input and ideas for larger Cambrex system level changes
Education, Experience & Licensing Requirements Ph.D. in Chemistry or related field with 8 years minimum experience or M.S. in Chemistry or related field with 12 years minimum experience or B.S. degree in Chemistry or related field with 16 years minimum experience in a laboratory environment.
Fundamental Understanding With Some Of The Following Analytical Technologies
Titrations (manual and automated)
Basic wet chemistry
HPLC, GC, GC/MS, FTIR, NMR, XRPD, laser diffraction particle size, TLC
Working knowledge of other analytical equipment common to the pharmaceutical industry
This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Safety and equal opportunity statements are provided by Cambrex in accordance with applicable law.
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