Job Description
Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Overview:
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.
Responsibilities:
- 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.
Qualifications / Skills:
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
Education, Experience, and Licensing Requirements: (Text Only)
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