Sr. Scientist II (ARD)

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 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 independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works 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. Responsibilities Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. May act as a team /project lead supporting scheduling of project tasks and deliverables Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others’ notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions Effectively and routinely provides training. With guidance, prepares well written and organized development reports Performs other related duties as assigned. Qualifications/Skills Working knowledge of experimental design, including chemistry supporting method development Working knowledge of advanced laboratory techniques Working exposure to cross functional techniques including organic chemistry. Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC) Able to comply to SOPs and have understanding of regulatory compliance Working knowledge of scientific concepts, principles and procedures Actively and positively engages with team and supports process improvements Ability to read and execute compendial methodologies Strong understanding of current FDA and cGMP regulations General knowledge of chemistry and scientific calculations Hands on experience in analytical techniques such as HPLC, GC, etc Strong computer skills Ability to operate laboratory equipment and computers Ability to take direction from experienced scientists and contributes in a team Environment Ability to effectively train and mentor others Good problem-solving skills Good attention to details Can repeat and follow detailed scientific procedures Able to clearly present results verbally in group meetings and in written progress reports Routinely and effectively presenting findings to clients Good interpersonal skills and is willing to ask questions about procedures and concepts Aptitude and willingness to gain more skills and knowledge in support of GMP regulations Good written and verbal communication skills Familiarity with computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel. Aptitude and willingness to gain more skills & knowledge. Good attention to detail and good problem-solving skills. Education, Experience & Licensing Requirements S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience Travel: Not applicable 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, 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. 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. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. 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. Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines Independently develop and evaluate methodologies, design and implement experiments. Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability. Maintains compliant records with little or no supervision Able to write technical documents with assistance Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions Sets up various instrumentation for testing according to written test methods and with little to no supervision. As needed, troubleshoots laboratory instrumentation Leads a sample project with assistance May participate in client level meetings, with approval May lead and develop other team members. May advise clients on site procedures. May act as a team /project lead supporting scheduling of project tasks and deliverables Responsible for ensuring compliance with cGMP and other regulatory guidelines. Analyze information for technical correctness and accuracy Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor Perform routine laboratory procedures in a timely and efficient manner Gain familiarization with analytical techniques Participate cGMP activities Provides input on SOPs and client questions Maintain laboratory equipment and supplies as directed May support peer-led laboratory investigations process with assistance Maintain a clean and safe work-space Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices Participate in group and project meetings as required Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems Attend seminars as required Participate in and comply with all current safety, health and environmental programs Shows initiative and interest in learning new techniques and tests Participates in technical discussions and brainstorming sessions Communicates issues or challenges to senior staff and/or management May review test data acquired by others and witness others’ notebooks Assists with writing technical documentation such as OOS, atypical investigations, deviations and CAPAs Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed Provides input on SOPs and client questions Effectively and routinely provides training. With guidance, prepares well written and organized development reports Performs other related duties as assigned. S./B.A. Chemistry with 8+ years of experience in related industry or MS with 4+ years related experience or PhD with 0+ years related experience