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!

Job Overview

As a Scientist within our Materials Characterization department, you will execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.

Responsibilities

• Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products.
• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
• Develop and implement test methods utilizing U/HPLC, GC, HPLC/MS, ICP-MS, XRD, LPS and/or various analytical techniques.
• Write standard operating procedures (SOPs), method qualification/validation protocols and reports (GMP/GLP), and research study reports.
• Follow SOPs and clearly documents all procedures and results in a GMP notebook.
• Develop and validate analytical methods for testing of drug substances and drug products.
• Perform technical review of notebooks.
• Operate HPLC, GC, ICP-MS, XRD, LPS, and other laboratory equipment.
• Additionally, you will write standard operating procedures (SOPs), method validation protocols, method validation reports and specifications.
• Supply weekly updates on long-term projects.
• With guidance, you will prepare well written and organized development reports to convey the quality of the methods to clients.

Qualifications/Skills

• Experience in chromatography and wet analytical chemistry is required.
• QC Release, Method development and validation experience with drug substance and drug product is preferred.
• Excellent academic and professional record with demonstrated laboratory skills and the ability to work in an interdisciplinary team environment.
• Minimum of 2+ years of experience in chromatography and wet analytical chemistry is required.
• Strong analytical chemistry skills, including HPLC, GC, and wet chemical methods.
• Experience operating HPLC and GC equipment and executing method validations and transfers.
• Experience in a cGMP environment is required.
• Knowledge of USP, EP, FDA and ICH requirements as they apply to production of drug substances and drug products is preferred.

Success Factors:

• Excellent customer service and communication skills are required.
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners and colleagues at all levels.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
• Highly goal and result oriented.
• Tackles problems with enthusiasm and curiosity.

Education, Experience & Licensing Requirements

• BS Degree or MS Degree in Chemistry or related discipline plus 1-5 years of industrial experience in a GMP environment is required.

Supervision Received:
Works under limited supervision.

Physical Demands, Work Environment, and Travel
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required.