We are seeking an experienced Analytical Chemist to join our dynamic team at Blue Signal Search. As a key member of our manufacturing and industrial team, you will play a crucial role in the development and validation of analytical methods, specification establishment, and pharmaceutical product testing.

• Collaborate with Innovation, Production, and Marketing departments to lead project development and ensure timely deliverables.
• Conduct second reviews of analytical results and provide feedback as necessary.
• Perform instrument troubleshooting, preventive maintenance, and operational qualification of laboratory equipment.
• Lead analytical tasks associated with product development and communicate progress to relevant departments.
• Draft specifications and standard operating procedures (SOPs) and generate protocols and reports.
• Facilitate training sessions for laboratory analysts during method transfer.
• Maintain a clean and organized laboratory environment to ensure compliance with regulatory standards.
• Actively participate in cross-departmental meetings and contribute insights as required.
• Review laboratory notebooks, provide constructive feedback, and ensure compliance with internal protocols.
• Design method validation protocols and execute validation experiments for drug substances and dosage forms.
• Analyze data, draw conclusions, and make recommendations based on experimental findings.

• Bachelor's, Master's or PhD degree in Chemistry or a relevant science discipline.
• Minimum of 5 years' experience in a regulated manufacturing environment.
• Experience in dissolution, drug impurity method development, and/or method validation preferred.
• Knowledge of ICH guidelines for drug product analysis and familiarity with analytical data regulatory submission requirements and quality by design principles preferred.
• Proficiency in chromatography techniques, including gas chromatography (GC) and high-performance liquid chromatography (HPLC).
• Strong understanding of cGMPs and GLPs, with familiarity in solid analytical techniques.
• Demonstrated ability to work independently and within a team environment with excellent written and verbal communication skills.
• Exceptional creativity, innovation, and decision-making skills.
• Proficiency in Microsoft Office suite and relevant software applications.
• Flexibility to work flexible hours when necessary.