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 Associate Director of QC Analysis is responsible for overseeing all cGMP testing activities associated with QC lot release, stability, in-house raw material testing, and assay transfer and validation. The Associate Director will be a key member of the management team that is responsible for the design, implementation, and continuous improvement of all processes/systems in support of all MacroGenics’ products. In addition, he/she will be responsible for developing and executing quality policies, practices, procedures, standards, and systems necessary to ensure adherence to aseptic production and product management in accordance to cGXP compliance to US and EU regulations.
Responsibilities and Job Duties:
• Manages and leads all activities associated with quality control release testing, stability testing, raw material testing, method transfer and validation:
• Oversee testing laboratories
• Ensure analysis is completed per schedule, peer reviewed and reported per schedule
• Ensure laboratory equipment is maintained and instruments calibrated
• Oversee intake of new methods from Development, completing qualification within the QC lab
• Responsible for method validation protocol creation, review and approval; Ensures execution is completed per protocal and validation report is completed
• Oversee out-of-specification investigations
• Communicate with Development to ensure the efficient transfer in of new methods
• Collaborates with Associate Director of QC Operations on reportable results per schedule. Incorporates intake calibration and maintenance activities into the laboratory plan.
• Manages the team and the processes ensuring all activities meet or exceed global current Good Manufacturing Practices.
• Contributes quality control expertise to regulatory filings (BLA, IND, IMPD, MAA) and regulatory responses.
• Drives and supports continued improvement efforts in quality systems to maximize organization effectiveness and ensure compliance with regulatory requirements and industry guidance.
• Supports activities for Pre-Approval Inspections and post approval routine inspections.
• Writes, reviews and approves Quality Control SOPs.
• Ensures compliance of all testing activities with applicable compendia (e.g., USP, NF, EP) and regulatory guidance documents.
• Partners with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data, as well as progress and completion of cross-functional projects.
• Hires staff and manages contract vendors for programs related to the QC Laboratory.
• Ensure continued professional development of staff through training and functional interactions with various operating groups.
• Creates a high-performing team that emphasizes strengths-based execution, accountability, open communication, people development and continuous improvement.
Education & Credentials
• Bachelor’s in Biochemistry, Chemistry, Chemical Engineering, Pharmaceutical Sciences or life sciences and a minimum of 9 years of related industry experience, including 6 years of experience in a cGMP Quality Control laboratory for testing biologics
• At least 5 years of direct people management experience including coaching and developing a team and providing motivation to accomplish goals and objectives
• Experience of regulatory inspections, particularly US FDA and EMA inspections as they relate to the assessment of cGMP Quality Control laboratories
• Experience in LIMS, particularly in LabVantage
• Experience in scheduling tools, and project management
Knowledge, Skills and Abilities
• Expertise in assay methodologies for protein-based therapeutic products, particularly antibodies, including separation techniques and bioassay (plate based and cell-based assays)
• Expertise in assay validation
• Expertise in equipment supporting methods
• Expertise in cGMP as it relates to Quality Control laboratories
• Strong communication and collaborative skills
• Ability to manage, train and mentor staff
• Strong communication, presentation, and writing skills
• Demonstrated skills working collaboratively and cross functionally
• Strong understanding of CMC functions
Will have two direct reports: Potency Laboratory Manager and Separations Laboratory Manager
• Experience in preparing analytical sections of regulatory documents such as IND, BLA and regulatory discussion documents
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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