Scientist, Quality Control

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA. Job Duties: Lead, provide, participate and execute analytical instrument qualification and equipment validation activities including development and execution of IQ/OQ/PQ Protocols/Reports Execute equipment troubleshooting and preventative maintenance activities to support QC lab operation in particular chromatography systems such as HPLC/UPLC, GC, in addition to MS, TOC, FTIR, UV-VIS, Karl Fisher titrators and others Write and assist others in writing protocols, methods, and reports to site requirements Actively support and train other chemists and technicians within area of expertise Lead in the maintenance of a high-quality and safe laboratory workplace Maintain and help support a working laboratory, including providing leadership in instrument troubleshooting, validation and qualification, maintenance and provision of laboratory supplies. Work in a team environment by communicating, leading, and assisting other team members Competencies: Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed. Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization's goals and values. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Education Requirements: Bachelor’s degree in Chemistry, Biochemistry, or other relevant scientific field with 7-10 years experience in cGMP environment. Master’s or PhD degree in relevant scientific field preferred Experience Requirements: Strong knowledge and understanding of analytical instruments and instrument qualification Troubleshooting and problem solving ability, and excellent oral and written communication skills Ability to multitask, and prioritize objectives from various projects, adhere to strict deadlines Analytical laboratory operations and laboratory technical leadership, especially in chromatography Strong GMP knowledge and in depth understanding of ICH and FDA regulations. Thorough understanding of problem-solving and quality improvement tools and techniques Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment

#J-18808-Ljbffr