Senior Director, Quality Control Analytical Sciences
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required
- A minimum of 0-2 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required
- Experience in a Quality Control setting is preferred
- Experience with biosafety cabinets is required
- Candidate must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance, training/systems applications
Responsibilities
- Lead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team (as needed)
- Be responsible for conducting training and qualifying QC Microbiology Specialists on QC test methods
- Work closely with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events were completed as scheduled and provide feedback as needed
- Conducts Observation, Side-by-Side, and Instructor Led Training inside of laboratory and CAR-T cGMP Manufacturing facility
- Conducts knowledge and skill check and independent performance qualifications for Quality Control Microbiology inside of laboratory and CAR-T cGMP Manufacturing facility
- Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations
- Support day to day Quality Control Microbiology activities as needed
- Perform peer review/approval of laboratory data as needed
- Helps write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments
- Optimizes the effectiveness and efficiency of training program in delivery of qualified personnel
- Work cross functionally with the training team to ensure the development/qualification processes
- Supports investigations and evaluates improvement opportunities for effective compliant training performance leading to sustained right first-time execution
- Provide awareness trainings to the Quality Control Microbiology team
- Performs trainings within CAR-T manufacturing facility inside of cleanroom environments
- Serve as subject matter expert for Learning Management Systems
- Support the maintenance and reporting of quality training metrics
- Other duties will be assigned, as necessary
Skills
QC Microbiology
cGMP
Training Delivery
Test Method Qualification
Cross-Functional Collaboration
Cell Therapy Testing
Legend Biotech
Develops and commercializes cell therapies
About Legend Biotech
Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.
Franklin Township, New JerseyHeadquarters
2014Year Founded
$146.4MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
1,001-5,000Employees