Scientist III (QC) or Sr. Scientist I (QC) - Cambrex

An experienced quality control chemist capable of testing and troubleshooting all common analytical methodologies.  This role is expected to understand all aspects of Quality Control processes. This individual will have the ability to execute difficult analytical methods as needed and provide leadership and training to junior Chemists. Able to organize routine work with minimal instruction from management and accurately evaluate and interpret generated data. This individual will demonstrate a strong understanding of compliance as related to the analytical laboratory.

• Maintain working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks.
• Responsible for ensuring compliance with cGMP and other regulatory guidelines.
• Perform assigned tasks carefully, safely and on schedule according to SOPs and supervisor instructions.
• Perform calibrations and verifications of instrumentation according to written procedures with no supervision.
• Executes all test methods required for quality control for the release of novel drug products, drug substances, in-process monitoring, and stability.
• Generate hand-written record of actions accurately and legibly on appropriate documentation with minimal errors.
• Compile, maintain, interpret and extrapolate results of analysis and communicate these results to supervisor.
• Utilize Laboratory Information Management System (LIMS) according to procedure for inventory management and data entry.
• Participate in group and project meetings as required.
• Maintain a clean and safe workspace.
• Maintain laboratory equipment and testing supplies as directed.
• May support laboratory investigations process with assistance.
• May assist with writing technical documentation for quality events such as OOS, atypical investigations, deviations and CAPAs.
• Enter project hours promptly and update project status on appropriate tracking and/or timekeeping systems.
• Attend and apply new training as required.
• Participate in and comply with all current safety, health and environmental programs.
• Communicate issues or challenges to senior staff and/or laboratory management and shares ideas of process improvements.
• Performs other related duties as assigned.

• Experienced analytical chemist with ability to develop safe chemical handling and disposal procedures.
• Effortlessly perform all analytical test methods required.
• Independently assess results against specifications and protocol acceptance criteria and provide training for junior analysts.
• Significant ability to critically assess current results against prior data.
• Effortlessly interpret and perform all compendial (USP, EP, etc.) methods with no guidance.
• Basic understanding of proper development of chemical characterization of materials and products.
• Ability to collaborate and provide technical related feedback to multiple functional technical departments with impact to overall project.
• Good understanding of the method development with ability to develop analytical methods and validation experiments independently.
• Provide excellent feedback on method improvements.
• Excellent understanding of cGMP requirements.
• Good understanding of laboratory-related regulatory guidelines.
• Collaborates with other technical departments to ensure laboratory compliance with no guidance.
• Flawlessly performs training of junior analysts on cGMP requirements and methods in the analytical laboratory.
• Demonstrates ability to provide regulatory strategy guidance.
• Excellent fundamental understanding and ability to use, investigate/correct root cause issues, repair, and train others to investigate and perform minor repairs to all common analytical instruments.
• Aware of instrument qualification principles.
• Excellent written and oral communication skills.
• Demonstrates excellent ability to receive and apply feedback for performance improvement.
• Effectively delivers accurate and constructive feedback to junior analysts and other departments.
• Demonstrates ability to communicate cross-functionally with other departments and clients with little to no supervision.
• Strong demonstration of problem-solving and ability to perform investigations.
• Demonstrates excellent ability to identify deadlines and independently perform all necessary testing within expected deadlines regardless of significant challenges.
• Demonstrates departmental leadership that effectively alters behavior holistically that is well received.
• Independently leads assigned tasks, aids, and trains peers.
• Demonstrates desire to lead initiatives that advance laboratory operations.
• Understands the principles of change management.
• Ability to record experiments legibly and accurately in laboratory notebooks freeform with minimal errors.
• Demonstrates ability to perform technical review of complex data and investigations recorded by peers.
• Demonstrates excellent critical thinking skills to identify mistakes in technical documents.
• Ability to independently create technical methods and procedures.
• Ability to independently record Quality Events with little to no guidance and few errors.
• Actively participates in key operational excellence initiatives.
• Active participation and support for implementation of Cambrex system level changes/initiatives.

• BS/MS in chemistry or similar science-related fields and 10+ years industry experience. Chemistry or Biochemistry degree preferred. PhD in Chemistry or Analytical Chemistry and 6+ years industry experience.