MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical 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.
The Manager of Quality Control – Potency is responsible for managing a team of QC professionals and overseeing the daily operations of the laboratory that performs potency and plate-based methods, including ELISAs and bioassays. This person will interact extensively with other department supervisors, Quality personnel, Manufacturing personnel, and other business partners in order to gather, analyze and disseminate necessary data and information. This person will also be responsible for the transfer and validation of potency, ELISA, bioassay and related test methods.
• Manages the team to ensure that priorities for lab scheduling, logistics and flow of activities for testing and review are established and followed and that workload is also prioritized, and staffing is maximized to ensure timely and effective performance.
• Provides direct supervision of QC analysts performing routine GMP testing of potency, bioassay, ELISA and related methods, assuming primary responsibility for communication of requirements and expectations of the employee’s daily job. Will perform all aspects of a supervisor’s role including hiring, coaching, developing, providing regular feedback to employee about his/her performance, and managing performance or behavioral deficiencies.
• Assures that analysts are trained on the relevant equipment and methodology, and that equipment is maintained and used properly.
• Provides first line troubleshooting as needed, and reviews related Quality event records (e.g., Deviations and CAPAs).
• Assists in designing and continuously improving Quality Control systems, processes and procedures.
• Writes and reviews departmental and interdepartmental SOPs covering analytical methods and general policies.
• Reviews, analyzes and trends laboratory data that may include raw material, in-process, lot release, and/or stability testing. Regularly reviews system suitability trend data within area of analytical division and assists with investigation of out of trend situations.
• Assists with developing, establishing, transferring, and validating testing methodology.
• Perform other duties as assigned.
Education & Credentials
• Bachelor’s Degree in a scientific discipline or related field of study with a minimum of 5 years of related experience
• At least 2 years of experience supervising staff demonstrating success with managing performance and productivity
• Significant experience in a GMP or GLP testing environment
• Significant knowledge of and experience with Quality Control processes, and method validation including drafting method validation protocols and reports
• Experience working on extremely complex problems in which analysis of situation or data requires an in depth evaluation of intangible variables
Knowledge, Skills and Abilities
• Ability to act independently to determine schedules, methods and procedures on new assignments
• Possesses the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
• Able to handle multiple priorities in a fast-paced environment
• Demonstrated ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
• Broad knowledge base of USA and ex-USA cGMP requirements for quality control testing
• Proficient in the use of Microsoft or equivalent software; word processing, email, spreadsheet or other analysis tools, database, and Internet
• Excellent written and verbal communications skills
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 firstname.lastname@example.org or call (301) 354-3566 and/or 711 for TTD/TTY service.
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