The incumbent will join a growing team of scientists and research associates engaged in discovery and translational research of several viral vaccines. This individual will be responsible to establish and manage a non-GLP serology testing laboratory within Discovery Vaccines. He/she will oversee activities related to sample management, equipment qualifications, assay throughput, data integrity, data transfer and documentation. Communication skills are essential to working in a team setting, and to communicate with functional groups outside of Discovery. This position requires the ability to organize the testing laboratory, ensure compliance to SOPs and business practices and supervision of employees. Experience in a GLP or similar environment is needed, and extensive experienced at running clinical assays in support of Vaccine or Biologics clinical trials under appropriate regulatory guidelines.
Oversee the set up, and management, of a non-GLP testing laboratory ensuring that all processes and instrumentation meet general principles of Good Laboratory Practice Supervise and train personnel running clinical assays in a regulated environment Manage sample tracking and inventory. Interact with external groups for acquisition of samples. Ensure laboratory equipment is qualified and properly maintained Ensure proper documentation practices are followed and necessary SOPs, documents and training records are in place Schedule sample testing and assay performance evaluations as needed Certify data integrity and accuracy Interact with members of Quality group to ensure best practices are in place Communicate with other Discovery teams to identify and arrange transfer of assays into the testing laboratory Comply with Takeda safety practices and standard operating procedures. Exhibit and promote Takeda`s Core Competencies.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
BS in with a minimum of 6 years relevant experience, a MS with a minimum of 4 years or a Ph.D with a minimum of 2 years relevant experience. Knowledge of GLP regulations and extensive experience working and/or supervising a compliant testing laboratory. Working knowledge of basic immunological methods and procedures Be well organized and detail orientated Ability to work independently with moderate supervision as well as collaboratively in a team environment. Experience working in a BSL-2 environment. Experience preparing SOPs, technical reports, protocols and summaries. Strong oral and written communication skills. Advanced word processing, data entry, data presentation and computer analysis skills.
- Comply with institutional certifications and requirements in a BSL-2 environment.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Typical laboratory standing, bending, stooping, lifting requirements apply.
- Lifting and moving supplies and equipment (up to 25 pounds).
- Willingness to travel to internal and external training, project and collaborator meetings, including overnight trips (expected to be infrequent).
- Requires approximately 5% travel.
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