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Sr Engineer I/II, Gene Therapy Tech Transfer, Drug Product Development - United States
Posted on : 24 June 2017
- As a member of our company's Gene Therapy Tech Transfer and Drug Product development team, the candidate will be responsible for creating, updating, and communicating technology (tech) transfer deliverables for adeno-associated virus production processes to contract manufacturing partners.
- This role requires the capability to lead both internal cross-functional teams and manage external manufacturing partners.
- Must be able to analyze complex issues and identify business process optimization opportunities.
- Must concisely and accurately articulate departmental priorities to stakeholders and assist in aligning departmental priorities.
- Coordinate and lead tech transfer meetings, attend process development sub-team meetings as necessary, and manage information flow and decisions.
- Responsible for (as appropriate) leading, facilitating, or coordinating all activities pertaining to tech transfer, which includes initial process/facility fit, process transfer, manufacturing readiness, production and testing, and tech transfer/project closeout
- Manage the tech transfer project schedule with external manufacturing partners and integrate this with other scheduling functions, so the schedule is visible and usable by relevant stakeholders
- Cultivate relationships with external business partners and internal stakeholder groups.
- Lead optimization projects resulting in improved (simplified, more robust, or clearer) business processes. Leads the implementation of the agreed-upon solutions and monitors effectiveness of new process(es).
- Coordinates reports/data in support of CAPAs, deviations, presentations, technology transfer optimization, and to support long-range business decisions
- Thorough understanding of technology transfer best practices
- Demonstrated knowledge of protein and adeno-associated virus production processes
- Demonstrate strong organizational skills and multiple project and time/resource management skills.
- Demonstrate excellent verbal and written communication.
- Demonstrate excellent interpersonal skills including the ability to resolve problems.
- Prior experience working in a biopharmaceutical development environment and familiarity with GMPs and FDA/ICH guidelines is preferred
- Ability to travel as needed (both domestically and internationally).
The ideal candidate will possess a B.S. in Chemical or Biotechnology Engineering or related discipline with at least 8 years of relevant work experience in biotechnology, an M.S./MBA degree with at least 6 years of relevant work experience or a PhD with relevant 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.
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