Principal Scientist Ii (Qc)

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:

• Strengthen connections with coworkers and the community
• 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

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!

• Able to write technical documents with assistance
• Ability to help identify risks for regulatory compliance or violation of site SOP
• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• Support method onboarding and testing of reference standards in a GMP environment.
• Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
• Routinely participates in compliance meetings to ensure that client requests are within boundaries of compliance
• Able to apply prior knowledge to accurately interpret structural data.
• Maintains compliant records with little or no supervision
• Independently develop and evaluate methodologies, design and implement experiments.
• Good understanding of the functional chemistry affecting analytical technique
• Strong understanding and proficiency in use and maintenance of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks

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

• As needed, troubleshoots laboratory instrumentation
• Routinely prepares well written and organized development reports
• Sets up various instrumentation for testing according to written test methods and with little to no supervision.
• Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed
• Maintain laboratory notebook and/or computer files (i.e. LIMS) according to standard, accepted practices
• Participate in group and project meetings as required
• Maintain a clean and safe work-space
• Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions
• May review test data acquired by others and witness others’ notebooks
• Communicates issues or challenges to senior staff and/or management
• May lead key operational excellence initiatives
• Assists with and may mentor others regarding writing technical documentation such as OOS, atypical investigations, deviations and CAPAs
• Participates in technical discussions and brainstorming sessions
• May participate in client level meetings, with approval
• Participate cGMP activities
• Responsible for ensuring compliance with cGMP and other regulatory guidelines.
• Attend seminars as required
• Provides input on SOPs and client questions
• Participate in and comply with all current safety, health and environmental programs
• May advise clients on site procedures.
• Routinely acts as a team /project lead supporting scheduling of project tasks and deliverables
• May support peer-led laboratory investigations process with assistance
• Shows initiative and interest in learning new techniques and tests
• Analyze information for technical correctness and accuracy
• Effectively and routinely provides training.
• Perform routine laboratory procedures in a timely and efficient manner
• Actively participates in recruiting efforts
• Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems
• Ability to author and review key technical documents with minimal RFT errors and can write new SOPs with manger assistance
• Maintain laboratory equipment and supplies as directed
• Leads a sample project with assistance
• Strong understanding of the use of analytical techniques to characterize materials
• Routinely leads and develop other team members.
• Compile, maintain, interpret and extrapolate data on results of analysis and communicate these results to supervisor
• Provides input on SOPs and client questions

• Performs other related duties as assigned.

• Expert in related technologies
• Working knowledge of experimental design, including chemistry supporting method development
• Ability to operate laboratory equipment and computers
• Can articulate and evaluate project concepts and strategy
• Operates with substantial latitude for independent actions and decisions relating to technical problems and procedures
• Actively and positively engages with team and supports process improvements
• Working knowledge of advanced laboratory techniques
• Demonstrates continued development in a relevant area of CMC
• Working knowledge of scientific concepts, principles and procedures
• Effective independent researcher
• Working exposure to cross functional techniques including organic chemistry.
• Subject matter expert in one or more instruments (i.e. GC, LC, dissolution, TGA/DSC)
• Ability to take direction from experienced scientists and contributes in a team
• Ability to read and execute compendial methodologies
• Hands on experience in analytical techniques such as HPLC, GC, etc
• Strong understanding of current FDA and cGMP regulations
• Strong knowledge of chemistry and scientific calculations
• Regularly conceives and applies innovative, technical solutions to a variety of problems
• Recognized as a technical resource in a related area
• Able to comply to SOPs and have understanding of regulatory compliance
• Good grasp of advanced scientific/technical reading, writing and verbal communication skills
• Strong computer skills

• S./B.A. Chemistry with 14+ years of experience in related industry or MS with10+ years related experience or PhD with 6+ years related experience