Job Description

Analytical Development And Quality Control

The candidate will work in the analytical development and quality control group to perform analytical method development/validation, and quality control testing of active pharmaceutical ingredients (API), raw materials, drug products and stability samples through the development cycle, and perform testing in support of formulation development.

This position is located in our Menlo Park, CA office.

Responsibilities

• Develop phase-appropriate analytical methods using LC, GC and dissolution apparatus
• Prepare analytical procedure SOPs and validation/verification/transfer protocols
• Perform method validation/verification/transfer
• Perform API, raw materials, in-process, drug product release and stability testing
• Manage material inventory in compliance with cGMP regulation.
• Maintain reagents and GMP material inventories through SRI procedures
• Perform in-house equipment calibration and preventive maintenance (PM) or arrange calibration/PM service from outside vendors according to equipment calibration and PM schedule
• Facilitate problem solving, investigations and process improvements in Analytical chemistry and Quality Control operations
• Archiving electronic and paper documents
• Ship and receive materials and test samples
• Perform basic tests following SOPs (pH, UV, IR, Karl Fischer titration, disintegration, etc.)
• Maintain safe, compliant, and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures (SOP)
• Work collaboratively in cross-functional teams
• Serve as a point of contact for stakeholders based on assigned responsibilities
• Other duties as assigned by the management
• Knowledge of LC-MS, NMR and advanced analytical techniques is preferable

Qualifications

• Bachelor of Science degree in Chemistry or related majors with five years or longer experience in pharmaceutical testing.
• Master's degree with at least three years of experience.
• Ph. D degree with 0-2 experience.
• Familiarity with U. S. Pharmacopeia testing and requirement, particularly in the dissolution and microbiological testing areas, is highly desirable.
• Ability to accurately multitask in fast paced environment.
• Good organizational skills, attention to details, attention to timeline and schedules.

The salary ranges for this posting are below.

• Research Scientist I -$88,370 - $117,090 - Ph. D degree with 0-2 experience.
• Bioscience Research Associate III - $78,220 - $103,640 - Master's degree with at least three years of experience.
• Bioscience Research Associate II - $61,220 - $81,120 - Bachelor of Science and five years of experience.

Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.

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