Senior Research Associate - Biophase : Job Details

Key Responsibilities:

• Perform both standard and complex analyses of samples related to ongoing projects, including testing for drug substance and product stability.
• Oversee and manage multiple development initiatives, from inception through execution.
• Review and assess analytical data to ensure adherence to established procedures and specifications.
• Contribute to and present findings in scientific meetings, both internally and externally.
• Organize and prepare data for quality control reviews and compliance.
• Update standard operating procedures (SOPs) as necessary, particularly those related to equipment, materials, and analytical methods.
• Develop, validate, and execute protocols for equipment and method qualification, followed by report generation.
• Draft scientific reports and contribute to regulatory documentation, specifically in Chemistry, Manufacturing, and Controls (CMC) sections.
• Investigate and resolve issues related to analytical results.
• Potentially develop or refine existing analytical methods.
• Apply Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in daily work.
• May have supervisory responsibilities, guiding one or more team members.

Qualifications:

• Bachelor's or Master's degree in Chemistry or a related field.
• At least 5 years (Research Associate) or 10 years (Senior Research Associate) of experience in analytical development and quality control.
• Proficiency with analytical techniques like HPLC, mass spectrometry, and gas chromatography.
• Knowledge of current GMP guidelines is advantageous.
• Strong experience with SOP-driven processes and methods.
• Capable of independently leading scientific projects and determining appropriate next steps based on experimental data.
• Excellent organizational abilities, with attention to detail in recording experimental outcomes.
• Skilled in operating and troubleshooting laboratory equipment.
• Strong written and verbal communication skills, adaptable to all organizational levels.
• Ability to meet deadlines and manage workload effectively to support team goals.
• Prior experience managing and coordinating development projects.
• A collaborative approach to teamwork, with an emphasis on problem-solving and respect for colleagues.
• Effective listener and communicator, with a constructive feedback style.