Senior Analyst I, Quality Control Chemistry

Overview

• Play a key role in ensuring the quality of innovative pharmaceutical products through advanced analytical methods and rigorous quality control processes.
• Support the development and validation of analytical methods for product release and stability testing, contributing to groundbreaking advancements in healthcare.
• Collaborate with multidisciplinary teams, including Quality Assurance, Manufacturing, and external laboratories, to maintain compliance and enhance operational efficiency.
• Engage in data trending, investigations, and quality event management to uphold high standards of product integrity and reliability.
• Prepare technical documentation such as SOPs, validation protocols, and reports to support regulatory and operational requirements.
• Contribute to laboratory operations, including instrument qualification, housekeeping, and reagent preparation, ensuring smooth workflows.
• Mentor and train junior staff, fostering professional growth and a collaborative team environment.
• Adapt responsibilities to align with the clinical phase, supporting dynamic project needs and priorities.

Key Responsibilities & Duties

• Perform analytical testing using techniques such as HPLC, LCMS, AUC, UV-Vis, and CE-SDS to ensure product quality and compliance.
• Review and approve cGMP analytical data for accurate product release and stability testing.
• Lead laboratory operations, including instrument maintenance, reagent qualification, and adherence to quality standards.
• Author and manage quality events such as change controls, deviations, CAPAs, and OOS investigations.
• Prepare comprehensive technical documentation, including validation protocols, reports, and standard operating procedures.
• Conduct method transfer and validation activities for internal and external laboratories, ensuring seamless integration and compliance.
• Collaborate with external contract laboratories to facilitate testing and validation processes effectively.
• Train and mentor junior team members, promoting skill development and a collaborative work culture.
• Adapt to evolving responsibilities to support clinical phase activities and organizational goals.

Job Requirements

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Biophysics, or a related field.
• Minimum of 5 years of experience in a cGMP QC laboratory within the pharmaceutical or biopharmaceutical industry.
• Proficiency in analytical techniques such as HPLC, LCMS, AUC, UV-Vis, and CE-SDS.
• Experience with external contract laboratories (CMOs, CROs) is advantageous.
• Strong collaboration, communication, and organizational skills to effectively manage tasks and projects.
• Ability to work independently and prioritize tasks in a dynamic and fast-paced environment.
• Demonstrated leadership and mentoring capabilities to foster team development and success.
• Adaptable to changing priorities and clinical phase requirements, ensuring alignment with organizational goals.
• Motivated and skilled in multitasking with excellent technical and organizational abilities.