Website Cambrex
Cambrex
Company : Cambrex
Overview:
Independently: perform analytical testing on reference standards and drug substance following established methods under GMP conditions. Maintain laboratory notebook and perform data review. Maintain lab instruments. Ensure compliance with applicable company SOPs and regulatory guidance.
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:
Essential Functions:
- Perform analytical testing utilizing established methods.
- Maintain and review notebook and data entries.
- Write reports, protocols and simlar documents
- Conduct reference standard characterizations
- Conduct analytical methods validation, and transfers
- Perform laboratory investigations.
- Participate in larger-scope projects
- Train laboratory colleagues
- Maintain equipment.
- Responsible for laboratory upkeep (supplies, chemicals, cleanliness, safety).
- This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.
- Occasionally, perform method development and pre-validation experiements with support
Qualifications / Skills::
Competencies:
- 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 client inquires related to SOP or regulatory guidance
- 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, GC/MS, laser diffraction particle size
► Working knowledge of other analytical equipment common to the pharmaceutical industry