The Scientist 1 - Quality Control role performs routine analytical testing on raw materials, intermediate, and final products as well as in-process testing; performs data entry; draft deviations, and participates in OOS investigations for their testing. Ensures compliance with applicable Company SOPs and regulatory guidance’s.

• Perform routine testing of raw materials, intermediate, and final products (may include stability)
• Provide support to the plant by performing in-process testing and analyzing cleaning samples.
• Maintain laboratory notebook.
• Ensure equipment is left in good working order after use.
• Perform laboratory upkeep (wash glassware, reorder supplies, check for expired chemicals).
• Draft their deviations.
• Be an active participant in their laboratory investigations.

Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry or Quality Control

Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry

GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance

Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed

Communication: Good oral and written communication skills

Problem Solving: May be asked to support peer-led laboratory investigation process with manager support

Time Management: Ability to handle key assignments, with supervision

Leadership: Shares ideas with peers

Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP

External Influence: Ability to work within a matrix team

Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team

Operational Excellence: Strives to engage in group/team improvement projects

Change Orientation: Able to understand the importance of Cambrex initiatives

M.S. in Chemistry or related field or B.S. degree in Chemistry or related field with 2 years minimum experience, or Technical Degree with 4 years minimum experience, or High School Degree with 6 years minimum experience.

Experience with and fundamental understanding of several of the following analytical technologies

(* - most important):

• HPLC*
• FTIR*
• Titration
• Basic wet chemistry*
• NMR
• XRPD
• cKF

Working knowledge of other analytical equipment common to the pharmaceutical industry

PI284937320