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.
Summary of Position
This position is responsible for scheduling and performing the inspection, sampling and testing of incoming raw materials to support manufacturing of MacroGenics clinical and commercial products. This individual will also be responsible for evaluating and establishing appropriate specifications of raw material for compliance with Regulatory and MacroGenics quality guidelines.
Responsibilities and Job Duties:
- Responsible for the inspection, sampling and testing of incoming raw materials (RM). Performs inspection, sampling and testing according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents and are completed per schedule and within established turn-around time.
- Serves as the technical liaison and project manager with contract testing laboratories. Collaborates with Materials Management to prepare shipments of raw material samples for testing performed by contract laboratories. Ensures that the contract laboratories are adhering to timelines and budgets as outlined in contracts. Assists in planning/scheduling activities in alignment with manufacturing and contract testing laboratories.
- Follows established procedures and perform tasks in accordance with cGMP requirements.
- Ensures all testing of raw materials is compliant with current compendia (USP/NF, EP, JP, ACS, and FCC as needed), MacroGenics approved specifications, and cGMP requirements.
- Assists in the development and revision of RM specifications, testing plans and SOPs, as needed for manufacturing of MacroGenics products and/or affected by compendia changes and/or changes arising from quality events.
- Assists in compendial review (USP, Ph.Eur., JP) for new and/or revised compendial requirements that apply to MacroGenics RM, and revises MacroGenics specifications accordingly.
- Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data per cGMP. Ensures data storage and archiving are performed per established procedures.
- 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. Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state.
- Maintains the sampling room at constant state of compliance and inspection readiness at all times and ensures that sampling room inventory is stocked with required cleaning solutions, sample containers, labels, etc. and coordinates with appropriate departments when there are issues/concerns.
- Reports discrepancies and nonconforming materials to management and supports subsequent investigations. Initiates and monitors progress of raw material and/or analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.
- Provides technical guidance as needed to contract laboratories to address and investigate invalid events and/or discrepancies.
- Maintains close interaction and communication with the Materials Management team and QA to ensure on-time and aligned raw-material-related decisions.
- 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 report findings and provides recommendation to supervisors for review and consideration.
- Collaborates with Senior QC 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.
- Participates in troubleshooting of raw material and analytical test methods and instruments, as needed.
- Performs special projects related to problems encountered with analytical testing and instruments, and make recommendations for solutions that will minimize future issues.
- Mentors and trains lower lever analysts, as needed.
- Prepares general lab solutions and buffers as needed and monitor expirations of these solutions and buffers.
- Other duties as assigned.
Education, Experience, & Credentials
- High School Diploma and minimum of 8years directly related experience
- Associate’s degree in scientific field of study and 5 years of experience
- Bachelor’s Degree in a scientific discipline and minimum of 4 years experience
- Experience in one or more of the following areas required: Quality Control, Raw Material testing, and/or GMP testing.
Knowledge, Skills and Abilities
- Demonstrate the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- 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 in depth evaluation of intangible variables.
- Working knowledge of good laboratory practices.
- Excellent understanding of GMPs related to the biotech or pharmaceutical industry
- Ability to act independently to determine methods and procedures on new assignments.
- Demonstrated 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.