Senior Scientist 1-Analytical Research and Development

Overview :

Role performs analytical testing on reference standards and drug substance following established methods under GMP conditions with minimal supervision.

Maintain laboratory notebook and perform some data review. Ability to maintain lab instruments with support. Ensure compliance with applicable company SOPs and regulatory guidance.

Conduct method validation and method transfers with some supervision. Support laboratory investigations as needed. With minimal supervision, conduct methods validation and method transfers, perform laboratory investigations and non-routine project work, participate in larger scope projects, author protocols and reports.

Troubleshoot instrumentation with support.

Responsibilities :

Perform analytical testing utilizing established methods.

Maintain and review notebook and data entries.

Write reports, protocols, and similar documents

Conduct reference standard characterizations

Conduct analytical methods validation, and transfers

Perform laboratory investigations.

Participate in larger-scope projects.

Train 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 : Good understanding of the principles of Analytical Chemistry with some practical laboratory experience.

Cross Discipline Knowledge : Basic understanding of the principles of cross-functional departments, including organic chemistry

GMP / Regulatory Knowledge : Demonstrated understanding of GMP; With manager input, can help to advise clients on key regulatory strategies

Instrumentation : Good fundamental understanding and ability to use / investigate issues with HPLC, GC

Communication : Good written and oral communication skills, able to handle client requests with manager review

Problem Solving : Able to solve problems in the workplace and helps to lead investigations with manager support.

Time Management : Reasonable ability to handle one or more tasks or projects, often with supervision

Leadership : Shares ideas with peers

Technical Documentation and Review : Ability to write technical documents with assistance

External Influence : Occasionally participates in internal project team meetings, as needed; demonstrated ability to work within a team matrix

Industry Credibility and Rapport : Known as a solid scientific contributor within the department / group

Operational Excellence : Demonstrated interest in improvement of operational aspects of the group / team

Change Orientation : Provides constructive feedback for Cambrex Initiatives

Qualifications :

Ph.D. in Chemistry or related field or M.S. in Chemistry or related field with 6 years minimum experience or B.S. degree in Chemistry or related field with 10 years minimum experience in a laboratory environment.

Fundamental Understanding with some of the following analytical technologies :

Titrations (manual and automated)

Basic wet chemistry

FTIR, NMR, XRPD, HPLC, GC

Working knowledge of other analytical equipment common to the pharmaceutical industry