Associate III, QC (Bioassay) - United States
- The QC Bio assay group in RTP, NC has an opportunity for an Associate III.
- QC Bio assay supports Quality Control testing of GMP samples using biological analytical methods, as well as reagent qualification testing, validation/transfer of analytical methods, and technical support of QC investigations.
- Must have the ability to model the leadership competencies and work effectively independently, within a team framework, and across all business areas and levels of the organization.
- Release and stability testing, as needed. Sound technical review for data and documentation.
- Authoring change control requests and quality technical reports, as needed. Participation and support of execution of method transfer and/or method/reagent qualifications, laboratory improvement projects, and troubleshooting of analytical methods in collaboration with teams as appropriate.
- Technical leadership through effective project management and input for decisions related to complex problem solving, while helping to manage non-complex problems routinely. Technical leadership as a subject matter expert in one or more disciplines.
- Leadership and mentoring as needed to aid in the development of their peers.
- Effective participation in leadership or membership roles for site cross-functional teams as a representative of the QC Bioassay laboratory related to laboratory improvements and projects.
- Maintenance of effective laboratory systems to ensure integrity of all laboratory results.
- Candidates must have experience with biological testing (bioassays, cell-based or not), ELISAs, potency and binding assays and extensive GMP experience, preferably in a commercial manufacturing environment.
- Excellent laboratory technique and experimental design
- Statistical experimental design and data analysis with JMP and Excel software
- Relevant experience in reagent qualification, method validation and transfe
- Excellent time management and prioritization skills
- Excellent oral and written communication and presentation skills
Biological Science degree is preferred with 3-5 years of relevant experience (MS degree) or 5+ years of relevant experience (BS degree)
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.