Associate Scientist II

Full Time
Posted Today
Job description
: 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 over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Overview: As an Associate Scientist, you will execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Responsibilities:
  • As an Associate Scientist, you will 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.
  • BS Degree or MS Degree in Chemistry or related discipline plus 1-5 years of industrial experience in a GMP environment is required.
  • 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.
The hiring range in Colorado for this position is $57,000– $74,000; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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