High Point, NC, 27261, USA
10 days ago
Senior Scientist 1-Analytical Research and Development
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 Role performs analytical testing on reference standards and drug substance following established methods under GMP conditions with minimal supervision. Maintain laboratory notebook and perform some data review. Ability to maintain lab instruments with support. Ensure compliance with applicable company SOPs and regulatory guidance. Conduct method validation and method transfers with some supervision. Support laboratory investigations as needed. W ith minimal supervision, conduct methods validation and method transfers , perform laboratory investigations and non-routine project work, p articipate in larger scope projects , author protocols and reports. Troubleshoot instrumentation with support. Responsibilities + Perform analytical testing utilizing established methods . + Maintain and review notebook and data entries . + Write reports, protocols, and similar documents + Conduct reference standard characterizations + Conduct analytical methods validation, and transfers + Perform laboratory investigations. + Participate in larger-scope projects. + Train laboratory colleagues. + Maintain equipment + This position works with and handles hazardous materials and wastes . Responsible for recognizing emergency situations concerning hazardous materials and wastes . Qualifications/Skills Analytical Chemistry Knowledge : Good u nderstanding of the principles of Analytical Chemistry with some practical laboratory experience. Cross Discipline Knowledge: Basic understanding of the principles of cross-functional departments, including organic chemistry GMP/Regulatory Knowledge : Demonstrated understanding of GMP; With manager input , can help to advise client s on key regulatory strategies Instrumentation: Good fundamental understanding and ability to use/investigate issues with HPLC, GC Communication: Good written and oral communication skills, able to handle client requests with manager review Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support. Time Management : Reasonable ability to handle one or more tasks or projects, often with supervision Leadership: Shares ideas with peers Technical Documentation and Review: Ability to write technical documents with assistance External Influence: Occasionally participates in internal project team meetings, as needed; demonstrated ability to work within a team matrix Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group Operational Excellence: Demonstrated interest in improvement of operational aspects of the group/team Change Orientation: Provides constructive feedback for Cambrex Initiatives Education, Experience & Licensing Requirements Ph.D. in Chemistry or related field or M.S. in Chemistry or related field with 6 years minimum experience or B.S. degree in Chemistry or related field with 10 years minimum e xperience in a laboratory environment . Fundamental Understanding with some of the following analytical technologies: + Titrations (manual and automated) + Basic wet chemistry + FTIR, NMR, XRPD, HPLC, GC Working knowledge of other analytical equipment common to the pharmaceutical industry Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is divided between performing in an office setting and walking in/out of the laboratories as well as standing for extended periods of time. Walking and standing are required. Position also requires visual acuity, talking, computer typing. 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.
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