ph3Job Description /h3 h3Company Information /h3 h3You Matter to Cambrex. /h3 pCambrex is a leading integral 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 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. /p h3Your Work Matters. /h3 pAt Cambrex, we strive to build a culture where all colleagues have the opportunity to: /p ul liengage in work that matters to our customers and the patients they serve /li lilearn new skills and enjoy new experiences in an engaging and safe environment /li listrengthen connections with coworkers and the community /li /ul pWe’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! /p h3Your Future Matters. /h3 h3Job Overview /h3 pExecute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. /p pRoutinely and effectively interacts with clients to discuss data and methods. /p pWorks on problems of moderate and sometimes advance 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. /p h3Responsibilities /h3 ul liExecute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines /li liIndependently develop and evaluate methodologies, design and implement experiments. /li liParticipates in experimental design, including development of methods and testing requirements to demonstrate method suitability. /li liMaintains compliant records with little or no supervision /li liAble to write technical documents with assistance /li liStrong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks /li liPerform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions /li liSets up various instrumentation for testing according to written test methods and with little to no supervision. /li liAs needed, troubleshoots laboratory instrumentation /li liLeads a sample project with assistance /li liMay participate in client level meetings, with approval /li liMay lead and develop other team members.



/li liMay advise clients on site procedures. /li liResponsible for ensuring compliance with cGMP and other regulatory guidelines. /li liAnalyze information for technical correctness and accuracy /li liCompile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor /li liPerform routine laboratory procedures in a timely and efficient manner /li liGain familiarization with analytical techniques /li liParticipate cGMP activities /li liProvides input on SOPs and client questions /li liMaintain laboratory equipment and supplies as directed /li liMay support peer-led laboratory investigations process with assistance /li liMaintain a clean and safe work-space /li liMaintain laboratory notebook and/or computer files LIMS) according to standard, accepted practices /li liParticipate in group and project meetings as required /li liEnter project hours promptly and update project status on appropriate tracking and/or timekeeping systems /li liAttend seminars as required /li liParticipate in and comply with all current safety, health and environmental programs /li liShows initiative and interest in learning new techniques and tests /li liParticipates in technical discussions and brainstorming sessions /li liCommunicates issues or challenges to senior staff and/or management /li liMay review test data acquired by others and witness others’ notebooks /li liAssists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs /li liAssists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed /li liProvides input on SOPs and client questions /li liWith guidance, prepares well written and organized development reports /li liPerforms other related duties as assigned. /li /ul h3Qualifications/Skills /h3 ul liWorking knowledge of experimental design, including chemistry supporting method development /li liWorking knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC. /li liWorking exposure to cross functional techniques including organic chemistry. /li liUnderstands the chemical properties relating to method development, qualification /validation and troubleshooting. /li liAble to comply to SOPs and basic regulatory compliance /li liWorking knowledge of scientific concepts,



principles and procedures /li liActively and positively engages with team and supports process improvements /li liAbility to read and execute compendial methodologies /li liStrong understanding of current FDA and cGMP regulations /li liGeneral knowledge of chemistry and scientific calculations /li liHands on experience in analytical techniques such as HPLC, GC, etc /li liBasic computer skills /li liAbility to operate laboratory equipment and computers /li liAbility to take direction from experienced scientists and contributes in a team environment /li lienvironment /li liGood problem-solving skills /li liGood attention to details /li liCan repeat and follow detailed scientific procedures with supervision /li liAble to clearly present results verbally in group meetings and in written progress reports /li liRoutinely and effectively presenting findings to clients /li liGood interpersonal skills and is willing to ask questions about procedures and concepts /li liAptitude and willingness to gain more skills and knowledge in support of GMP regulations /li liGood written and verbal communication skills /li liFamiliarity with computer software such as Empower ChemDraw, Microsoft Word, PowerPoint, and Excel. /li liAptitude and willingness to gain more skills knowledge. /li liGood attention to detail and good problem-solving skills. /li /ul h3Education, Experience Licensing Requirements /h3 ul li pCambrex 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. /p pbTravel: Not applicable /b /p pbPhysical Demands /b /p pThe 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, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required. /p pbEnvironment and Protective Equipment /b /p pThe 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. /p /li /ul /p #J-18808-Ljbffr

📌 Talent Pipeline - Sr. Scientist I (Ard) (Málaga)
🏢 Cambrex
📍 Málaga