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! Job Overview Thank you for considering a future opportunity with Cambrex! If you are interested in joining our team but don't see a current role that fits your background, please submit your resume here. If we have future opportunities that match your skillset, we will contact you. While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Materials Characterization function. Cambrex's Materials Characterization positions will be on-site at one of our 14 locations. Locations include: Agawam, Massachusetts, Charles City, Iowa, Durham, North Carolina, East Rutherford, New Jersey (HQ), Edinburgh, UK, High Point, North Carolina, Karlskoga, Sweden, Liege, Belgium, Longmont, Colorado, Paullo, Milan, Italy, Tallinn, Estonia, Waltham, Massachusetts, Waterford, Ireland, and Wiesbaden, Germany. Responsibilities Sample Job Description: 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. Search Tags: PSD, particle size distribution, LPS, Laser Particle size, Malvern Mastersizer 3000, SympaTec, Horiba, ICP-MS, XRD, Method Development, particle size Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.