TALENT PIPELINE - Scientist II (Analytical R&D)- ...

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 Weu2019re 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 Analytical R&D function. Cambrex's Analytical R&D positions will be on-site at our Durham, NC site. Responsibilities Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work with supervision and to evaluate and interpret generated data. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Qualifications/Skills Duties and Responsibilities u2022 Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines u2022 Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. u2022 Maintains compliant records with little or no supervision u2022 Able to write technical documents with assistance u2022 Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks u2022 Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions u2022 Sets up various instrumentation for testing according to written test methods and with little to no supervision. u2022 As needed, troubleshoots laboratory instrumentation u2022 Leads a sample project with assistance u2022 May participate in client level meetings, with approval u2022 Responsible for ensuring compliance with cGMP and other regulatory guidelines. u2022 Analyze information for technical correctness and accuracy u2022 Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor u2022 Perform routine laboratory procedures in a timely and efficient manner u2022 Gain familiarization with analytical techniques u2022 Participate cGMP activities u2022 Maintain laboratory equipment and supplies as directed u2022 May support peer-led laboratory investigations process with assistance u2022 Maintain a clean and safe work-space u2022 Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices u2022 Participate in group and project meetings as required u2022 Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems u2022 Attend seminars as required u2022 Participate in and comply with all current safety, health and environmental programs u2022 Shows initiative and interest in learning new techniques and tests u2022 Participates in technical discussions and brainstorming sessions u2022 Communicates issues or challenges to senior staff and/or management u2022 May review test data acquired by others and witness othersu2019 notebooks u2022 Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs u2022 Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed u2022 With guidance, prepares well written and organized development reports u2022 Performs other related duties as assigned. Education, Experience & Licensing Requirements Skills and Competencies u2022 Working knowledge of experimental design, including chemistry supporting method development u2022 Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. u2022 Working exposure to cross functional techniques including organic chemistry. u2022 Able to comply to SOPs and basic regulatory compliance u2022 Working knowledge of scientific concepts, principles and procedures u2022 Actively and positively engages with team and supports process improvements u2022 Ability to read and execute compendial methodologies u2022 Strong understanding of current FDA and cGMP regulations u2022 General knowledge of chemistry and scientific calculations u2022 Hands on experience in analytical techniques such as HPLC, GC, etc u2022 Good computer skills u2022 Ability to operate laboratory equipment and computers u2022 Ability to take direction from experienced scientists and contributes in a team environment u2022 Good problem-solving skills u2022 Good attention to details u2022 Can repeat and follow detailed scientific procedures with supervision u2022 Able to clearly present results verbally in group meetings and in written progress reports u2022 Good interpersonal skills and is willing to ask questions about procedures and concepts u2022 Aptitude and willingness to gain more skills and knowledge in support of GMP regulations u2022 Good written and verbal communication skills u2022 Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. u2022 Aptitude and willingness to gain more skills & knowledge. u2022 Good attention to detail and good problem-solving skills. Education, Experience, and Other Qualifications u2022 B.S./B.A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience 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. Environment and Protective Equipment The work environment characteristics described here are representative of those an employee encounters while performing 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 occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. Travel: Little to no expected travel time. 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. #LI-SK1

Created: 2025-12-05