Method Development/QC Analyst
Summary of Position
The QC Analyst III will be working on development and qualification of analytical methods for clinical biotherapeutic products, to be used in the Quality Control lab for release and stability testing to support MacroGenics’ multiple clinical programs and fast-paced pipeline. This individual will be required to execute experiments, analyze and present data, and help write development, qualification and validation reports. An additional responsibility is to perform routine and non-routine review of testing of products for Quality Control following GMP guidelines.
Responsibilities and Job Duties
- Participates in the development, transfer, optimization, troubleshooting, qualification and validation of ELISA, Bioassay, cell bank establishment, HPLC, CE as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality to support MacroGenics’ multiple clinical programs and fast-paced pipeline. Manages supply and qualification of new critical reagent lots for potency testing; coordinates with suppliers/vendors to ensure proper reagent performance.
- Performs peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs. Identifies analytical data trends and reports findings and provides recommendation to supervisors for review and consideration.
- Conducts investigation when there are out of specification results from testing and reports to supervisor.
- Develops, revises, and updates standard operating procedures, as needed.
- Collaborates with Senior QC team members to conduct training to analytical test methods to other QC Analysts as needed.
- Overseas lab equipment calibration and maintenance processes as required for testing per standard operating procedures and raises any concerns about equipment to supervisor for resolution.
- Participates in troubleshooting of analytical test methods and instruments, as needed.
- Performs special projects related to problems encountered with analytical testing and instruments and makes recommendations for solutions that will minimize future issues.
- Mentors lower lever analysts, as needed.
- Performs other duties as assigned
- Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
Education, Experience, & Credentials
- High School Diploma and minimum of 8 years directly related experience
- Associate degree in scientific field of study and 5 years of experience
- Bachelor’s Degree in a scientific discipline and minimum of 4 years of experience
- Experience in one or more of the following areas required: Method development/qualification/validation, Potency testing, Chromatography testing, Quality Control, and/or GMP testing.
Knowledge, Skills and Abilities
- Working knowledge of good laboratory practices.
- Good understanding of GMPs related to the biotech or pharmaceutical industry
- Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.
- Ability to work on extremely complex problems in which analysis of situation or data requires an in‑depth evaluation of intangible variables.
- Ability to act independently to determine methods and procedures on new assignments.
- Demonstrate the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Demonstrating ability to coach and train others.
- Be able to work in a team environment in a cooperative and respectful manner.
- Ability to stand for periods of time when performing tasks on the floor.
- Ability to work a varied schedule including off shift and weekends.
- Ability to lift up to 50 pounds.