QC Analyst III / Sr. Analyst - Potency/Residuals

Description

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.

MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity and embrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive!

Summary of Position

This position is responsible for performing activities to support analytical testing programs at MacroGenics to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will guide and partner with lower level QC analysts to provide feedback and technical information. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.

Responsibilities and Job Duties:

• Performs 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, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).
• Perform cell culture for both adherent and suspension cells and independently plate/monitor and set up bioassays as needed.
• 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.
• Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
• Develops, revises, and updates standard operating procedures, as needed.
• Collaborates with Development (Analytical Sciences) team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.
• Collaborates with partners and CDMOs for tech transfer and method validation as needed.
• Oversees 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 and trains lower lever analysts, as needed.
• Authors Reports, protocols as well as memos for validation, critical reagents and etc.
• Keeps track of Critical Reagent inventory and current expiration dates Keeps track of failed samples, performs data reviews of failed samples as needed, helps review protocols, reports, create templates/overlays, creates SoftMax Templates and reviews SoftMax Templates.
• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
• Orders reagents as needed.

Qualifications

QC Analyst III

Education, Experience, & Credentials

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

Sr. QC Analyst

Education, Experience, & Credentials

• Bachelor's Degree in a scientific discipline and minimum of 6 years' experience in GMP environment
• Experience in one or more of the following areas required: ELISA, Bioassays, Potency testing, Residuals, Quality Control, Raw Material testing, and/or GMP testing.

Knowledge, Skills and Abilities

• Working knowledge of good laboratory practices.
• Excellent understanding of GMPs related to the biotech or pharmaceutical industry
• Extensive experience in working different types of cell lines both adherent and suspension cells.
• Working knowledge of aseptic technique
• 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. (LIMS).
• Working knowledge of LIMS (Laboratory Information Management Systems )
• Working knowledge of SoftMax Pro, Prism and JMP.
• 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 indepth 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.

Supervisory Responsibilities

None

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. Analyst). 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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.