- The candidate will be responsible for coordinating all analytical and technical deliverables of a CMC section of regulatory filings within company’s Gene Therapy portfolio.
- This includes coordinating development work between Gene Therapy Analytical Development and Process Development line functions according to Gene Therapy Asset team timelines and goals.
- The successful candidate will be responsible for leading effective technical team meetings, representing gene therapy Analytical and Process Development to the Asset teams and other functional sub-teams (e.g., Regulatory CMC, Quality), and keeping the line functions well-informed about decisions, achievements, risks, and cross-functional context for gene therapy programs.
- Responsibilities will include authoring analytical chapters to support regulatory filings, coordinating proposals of specifications and comparability strategies, and providing responses to questions from regulatory agencies.
- Demonstrated project management expertise. Ability to manage multiple activities simultaneously and prioritize across projects
- Team leadership abilities, particularly in a cross-functional, matrixed environment.
- Excellent verbal and written communication skills
- Greater than 10 years of analytical or technical development experience
- Experience coordinating CMC activities for gene therapy products
- Demonstrated professional maturity and breadth of experience.
The ideal candidate will possess a PhD in Analytical Sciences, Biochemistry, Biological Sciences or related discipline with at least 8 years of development experience in biotechnology industry, or M.S. degree with at least 12 years of development work experience.
- 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.