QC Bioassay Scientist (I/II)

Job Responsibilities

• Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
• Work with management and vendors to acquire, install, and qualify new equipment.
• Manage samples and associated documentation for duration of sample lifecycle, both physically and electronically.
• Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
• Develop and execute ELISA, cell-based, other types of immunoassays, and plate based analytical methods for small molecules, proteins, and antibody drug conjugates with minimal supervision.
• Support lab management by tracking and replenishing critical reagents and consumable inventory.
• Conduct analytical testing of raw materials, in-process, finished, and stability samples in a GMP-compliant laboratory, with a primary but not limited focus on bioassays.
• Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
• Ensure test methods development and execution activities are conducted in accordance with applicable regulatory requirements, internal policies, scientific standards, and project timelines.
• Document work in laboratory notebooks and logbooks according to organizational GDP policies.
• Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
• Manage work outsourced to third-party analytical and metrology service providers if needed.
• Perform detailed peer review of analytical data to ensure accuracy.
• Perform other tasks and assignments as needed and specified by management.

Qualifications: Required Skills and Knowledge

• Strong background in analytical sciences.
• Hands-on experience with various analytical techniques, including ELISA, PCR, SPR, BLI, flow cytometry, microscopy, Western blot, cell culture, etc.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil the business need.

Education and Experience Requirement

• BS, MS, or PhD degree in chemistry, biology, biochemistry, or related discipline.
• 0 - 5 years of experience in a GMP manufacturing or CRO setting.

Physical Demand

• Typically requires standing and walking for entire shift.
• Occasionally requires lifting of up to 20 pounds.
• Frequently requires the use of a step stool.
• Requires manual dexterity and visual abilities.

Working Condition

Office/Laboratory position.