MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 350+ 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.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Responsibilities and Job Duties:

• Performs routine analytical testing including more complex methods such as ELISA, bioassays, and Cell Culture as well as basic methods such as residuals using kits, PS80 ELISA for product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).
• Performs peer review of test data generated by other analysts as needed to ensure data integrity and adherence to standard operating procedures and GMPs.
• Reports out of specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
• Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
• Identifies opportunities for process improvement and makes recommendations to team leader.
• Revises and updates standard operating procedures, as needed.
• May participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.
• Write deviations and CAPA and be part of the investigation
• Participate in tech transfers from CDMOs and Development group for Potency and residuals methods
• Perform lab chorus and collaborate with the team to receive the reagents.
• Coordinate with QA to address quality control records, revision of SOPs, and etc.
• Work collaboratively across functional groups and departments
• Perform critical reagent qualifications as needed
• Write memos, compile data, trend data as needed.
• Work under GMP environment
• Ability to work in fast paced environment
• Help train other analysts as needed
• All other tasks assigned

Qualifications

QC Analyst II 

Education & Experience

• Bachelor’s Degree in a scientific discipline and minimum of two year of direct related experience
• Experience in one or more of the following areas required: ELISA, Bioassays, Cell Culture, Quality Control, and GMP testing.

QC Analyst III

Education & Experience

• Bachelor’s Degree in a scientific discipline and minimum of 4 years experience
• Experience in one or more of the following areas required: ELISA, Bioassays, Potency testing, Quality Control, Raw Material testing, and/or GMP testing.
  

Knowledge, Skills and Abilities

• Strong knowledge of good laboratory practices.
• Ability to work independently on assigned methods and follow procedures.
•  Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.
•  Ability to resolve problems independently and responsively but also know when to raise issues with management.
•  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.

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $68,400 to $102,700 (QC Analyst II) and $78,700 to $122,100 (QC Analyst III). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company’s discretionary bonus and discretionary equity incentives. 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. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. 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. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [email protected] or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled