Quality Control Specialist

3 weeks ago

Rockville, Maryland, United States MacroGenics Full time

Job Summary

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

Key Responsibilities

  • Perform analytical testing programs to ensure compliance with cGMP standards, including in-process, product release, and stability testing.
  • Guide and partner with lower-level QC analysts to provide feedback and technical information.
  • Ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.
  • Perform routine analytical testing, including complex methods such as ELISA, Bioassays, and Cell Culture, as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality.
  • Enter data into Laboratory Information Management System (LIMS).
  • Perform 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.
  • Identify analytical data trends and report findings and provide recommendations to supervisors for review and consideration.
  • Conduct investigations when there are out-of-specification results from testing and report to supervisor.
  • Initiate and monitor progress of analytical related Quality event records.
  • Collaborate with Development (Analytical Sciences) team members to participate in the development, transfer, and validation of analytical testing methods.
  • Conduct training on analytical test methods to other QC Analysts as needed.
  • Oversee lab equipment calibration and maintenance processes as required for testing per standard operating procedures.
  • Raise any concerns about equipment to supervisor for resolution.
  • Perform special projects related to problems encountered with analytical testing and instruments, and make recommendations for solutions that will minimize future issues.
  • Keep track of Critical Reagent inventory and current expiration dates.
  • Keep track of failed samples, perform data reviews of failed samples as needed, and help review protocols, reports, create templates/overlays, create SoftMax Templates, and review SoftMax Templates.
  • Prepare general lab solutions and buffers as needed and monitor expirations of these solutions and buffers.

Requirements

  • Bachelor's Degree in a scientific discipline and minimum of 4 years experience in GMP environment for QC Analyst III.
  • Bachelor's Degree in a scientific discipline and minimum of 6 years experience in GMP environment for QC Analyst.
  • Working knowledge of good laboratory practices.
  • Excellent understanding of GMPs related to the biotech or pharmaceutical industry.
  • Experience in building, reviewing SoftMax Pro templates.
  • Working knowledge of usage of cell counter, plate readers (M5, M2, L-reader) as well as Laboratory Information Systems.

Additional Information

The annual rate of pay for this position ranges from $78,700 to $122,100 (QC Analyst III) and $98,600 to $152,900 (Sr.). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law.

No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans.

Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law.

We are committed to working with and providing reasonable accommodation to individuals with disabilities.

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