TriLink Biotechnologies is seeking a Senior QC Associate. As part of the QC team at TriLink Biotechnologies, this individual will be responsible for Analytical Method Validation/Qualification and Method Transfer from internal development as well as from external customers. The role also requires to sustain the activities for QC Analytical to support Assays for the core Manufacturing, Quality, R&D, and GMP. This successful candidate will thrive in a fast-paced environment and will serve as a technical expert and in lab support for QC for all equipment and method related needs. Responsibilities include:
• Partner with internal and external customers to transfer, qualify, and/or validate new assays and methods
• Independently conducts analyses and interprets results
• Set up, troubleshoot, and make adjustments to laboratory equipment
• Performs routine to complex laboratory analyses and experiments with no supervision
· Transfer, modify, and improve analytical methods for HPLC, UHPLC, and LCMS
· Serves as a technical lead on projects and provides direction to various levels of chemist
· Compose Standard Operating Procedures (SOPs), Analytical Protocols, Analytical Reports, and GMP documents
· Method and system qualifications
• A Bachelor’s of Science or advanced degree in Chemistry or a related science required with a minimum of eight (8) years experience on analytical bench working with analytical method qualification/validation and method transfer experience. Demonstrated fundamental knowledge of various instruments and wet chemical analytical techniques
• Solid understanding of theory and operating principles techniques of HPLC, UHPLC, LCMS, UV/Vis, pHmeter, Osmometer, etc. Knowledge working with Chromeleon software desirable
• Strong GMP and GLP background is highly desirable
• Experience with ISO 9001 and ISO 13485 requirements preferred
TriLink Biotechnologies is a rapidly growing biotech firm in San Diego, CA that offers competitive wages and a full benefit package including medical, dental, vision, LTD, and a retirement plan.
TriLink Biotechnologies is an EEO employer.