Technical Reviewer

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!

The Technical Reviewer will work independently to provide a technical review for small and large molecule development and testing data in compliance with cGMP/cGLP standards and FDA / EU regulations. This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed within the specified time frames. Ability to work within a dynamic and fast paced environment.

• Responsible for performing an independent technical review of all analytical (small and large molecule entities) GxP testing performed on starting materials, raw materials, intermediates, drug substance, drug product, packaging components, customer samples, stability study samples, in- process testing/checks, etc. for completeness, accuracy and compliance
• Good understanding of analytical laboratory practices and able to apply quality assurance principles to the review process to ensure data is scientifically sound and compliant with all regulatory body requirements and local procedures
• Reviews technical documents such as protocols and technical reports for qualification/validation and stability activities, as required
• Works with analyst and laboratory management to conduct and document laboratory investigations
• Provides accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates
• Escalates issues which may impact timeline to laboratory and quality management
• Ensures all issues/documentation is complete prior to approval
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals
• Good interpersonal skills and willing to ask questions about procedures and concepts
• Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs
• Able to be trained
• Effectively resolves quality issues and concerns in a timely manner
• Effectively coordinates and organizes tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency
• Cre…