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Manufacturing Scientist II, Mfg Sciences (Gene Therapy)
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitleManufacturing Scientist II, Mfg Sciences (Gene Therapy)
Job DescriptionThe incumbent will provides the technical leadership in regards to viral vector manufacturing at internal & external partners including technical transfers, providing regulatory relevant manufacturing documents, trouble shooting and process improvements. The person works in Global Manufacturing Science and works closely with internal key functions like technical/analytical development, quality, manufacturing operations, regulatory, and planning.

The incumbent will deliver value to the business by offering engineering and scientific leadership to support clinical and commercial manufacturing processes; Lead technology transfer teams, identify opportunities to improve processes/systems (Scale up), and provide management and leadership to cross functional teams. Also this individual will provide interpretation of development / manufacturing data and communicate data to all levels of management. Also as part of tech transfer activities provide technical risk assessments for new manufacturing processes and develop project plans, timelines, and communication forums to ensure a smooth information transfer.

Job Responsibility

•The person will further ensure the standardization of processes across the gene therapy platform and co-ordinate necessary activities and projects related to establishing and building consistency for GMP. In this role the person will also work closely with Technical Development, Manufacturing, and engineering to understand which technologies and capabilities exists across the sites and /or are required to expand capacity and technical capabilities in order to bring in new products, which require those technologies

•Lead / support tech transfer and documentation of process development to validation activities. Leverage and develop where needed standard work practices to support current and future programs. Develop, improve, and document GMP methods, protocols, SOPs, and systems when needed.

•Represent Biogen CMC / PO&T by building relationships with external partners and CMOs.

•Responsible for the manufacturing support and person in plant (PIP) planning at CMO /internal manufacturing for the gene therapy products
LocationCambridge, MA, US
Job CategoryManufacturing
Requisition Number32126BR
•10 years' experience ideally in the pharmaceutical industry and in the area of gene therapy research or manufacturing

•An advanced university degree in biological sciences, process engineering or similar.

•Understanding of analytical techniques specific to the gene therapy process and is able to set specification for in-process-controls, release and stability indicating parameters

•Experience in TD and Mfg process data evaluation

•Technical process understanding of manufacturing of viral vectors for gene therapy

•Experience and knowledge of technology transfer tool application in the GMP manufacturing

•Proficiency in partnership, leading by influence, communication, project management, innovation and continual improvement
EducationPhd Chemical Engineering, Biology, virology
Cell Biology preferred
About BiogenCorporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen 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). Biogen 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.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

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 Biogen 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, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars 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. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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