Scientist II (ARD)

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 2,400 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!

• 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
• Routinely participates in compliance meetings to ensure that client requests are within boundaries of compliance

• Proficient with a broad range of laboratory techniques and actively investigate new technologies
• Attend and may participate in national and international scientific meetings
• Independently plan, perform and analyze experimental results in a timely manner
• Draft and execute validation protocols for analytical methods
• Perform and review data analysis and draft reports for analytical method development and validation
• Demonstrate ability to correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up and supervision
• Identifies and troubleshoots analytical problems with instrumentation, general chemistry, test methodology and samples submitted

• 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
• Strong understanding of 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 and may mentor others regarding 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.
• Actively participates in recruiting efforts
• Routinely prepares well written and organized development reports

• Performs other related duties as assigned.

• Working knowledge of experimental design, including chemistry supporting method development
• Good grasp of advanced scientific/technical reading, writing and verbal communication skills
• Regularly conceives and applies innovative, technical solutions to a variety of problems
• Effective independent researcher
• Can articulate and evaluate project concepts and strategy
• Operates with substantial latitude for independent actions and decisions relating to technical problems and procedures
• Recognized as a technical resource in a related area
• Expert in related technologies
• Demonstrates continued development in a relevant area of CMC
• 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.

• 
  S./B.A. Chemistry with 10+ years of experience in related industry or MS with 6+ years related experience or PhD with 2+ years related experience