Principal Scientist 1 - ARD

Cambrex•High Point, NC

About The Position

Principal Scientist 1 - 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, understand regulatory requirements and recommend Analytical approaches to clients and CHP colleagues. With some support, lead larger scope projects including cross-site projects within Cambrex.

Requirements

Analytical Chemistry Knowledge: Beginning to demonstrate an 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: Demonstrated understanding of industrial GMP and practical application to Cambrex programs; some ability to provide feedback to clients re: clinical strategy
Instrumentation: Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others)
Communication: Good written and oral communication skills, ability to communicate with clients without manager supervision.
Problem Solving: Strong demonstration of problem solving, ability to lead investigations
Time Management: Able to maintain timeline of key activities and use time efficiently; ability to handle projects without supervision though requires regular check in with manager
Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up
Technical Documentation and Review: Ability to author and review key technical documents with minimal RFT errors. Can write new SOP with manager assistance.
External Influence: Ability to lead local project teams and steer clients to desired outcomes; ability to work with management to develop key local laboratory-based initiatives
Industry Credibility and Rapport: Recognized scientific leader within the Cambrex organization, locally and possibly beginning to extend to other sites
Operational Excellence: Actively participates in key operational excellence initiatives
Change Orientation: Active participation and support for implementation of Cambrex system level changes/initiatives
Ph.D. in Chemistry or related field with 6 years minimum experience or M.S. in Chemistry or related field with 10 years minimum experience or B.S. degree in Chemistry or related field with 14 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.

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.
Review and revise SOPs
Perform laboratory investigations.
Lead laboratory investigations for Analytical and QC.
With support 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.