Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.
The Analytical Document Scientist will be responsible for reviewing laboratory data, notebooks, protocols, reports, investigations, etc. related to method development, method transfer, method validations, and instrument qualifications along with supporting documentation to ensure that they are compliant with SOPs, compendia, cGMP, ICH, and other regulatory guidelines and requirements. Serves as AD representative for QA, scientific, technical discussions around data, documentation and review.
- Reviewing data including, but not limited to: notebooks, logbooks, spectra, chromatograms, other instrument output and other supporting information.
- Reviewing analytical documentation to support the qualification, calibration, and maintenance of laboratory instrumentation and other systems and ensuring documentation (including investigations/deviations) are in compliance with applicable regulatory guidance and summarizing findings, and recommending approval or non-approval.
- Reviewing protocols, reports, investigations and other documents to ensure reporting accuracy and their adequacy with all required standards.
- Working with laboratory staff to complete necessary corrections and forwarding reviewed documents to QA.
- Maintain open communication with AD group members and with QA to ensure timely delivery of completed documents/records to QA.
- Continuously improve documentation systems and analytical data reporting to increase efficiency and compliance with GMP and/or other regulatory requirements.
- Prepare SOPs, protocols; perform scientific/technical data analysis and create scientific reports and technical documents for presentation.
All employees are required to adhere to DEA, EPA, FDA and cGMP and other applicable regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
- BS in scientific discipline, preferably in Chemistry or pharmacy or a related field with minimum of 5 years’ experience in a pharmaceutical and cGMP environment is highly preferred.
- Advanced technical writing skills and ability to communicate effectively with peers, department management and cross- functional co-workers.
- Experience in a laboratory environment or performing QA data review is highly preferred.
- Familiar with Microsoft Office package with proficiency in Word and Excel.
- Knowledge of analytical instrumentation (GC, HPLC, FTIR, UV-VIS, NMR, etc.) is preferred.
- Experience with Waters Empower chromatography software is preferred.
- Strong background in data review with proven ability to handle various project loads is beneficial.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and to handling complex issues independently.
- Ability to deal with nonverbal, logical or scientific symbolism such as formulas, scientific equations, graphs, and to deal with a variety of abstract and concrete variables.
- Comprehensive understanding of applicable regulatory guidelines with ability to independently develop, write and review methods, protocols, reports and other related documents.