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Posted:
8/16/2017
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Science
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Supervisor, Quality Control (Materials)
Biogen | Research Triangle Park, North Carolina
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Job Description

External Posting TitleSupervisor, Quality Control (Materials)
Job DescriptionThe QC Materials group in RTP, NC has an opportunity for a Supervisor. QC Materials team supports Quality Control testing of all raw materials/process aids used within the Biogen manufacturing area, as well as material qualification testing, validation/transfer of analytical methods, and technical support of QC investigations. This oversight includes QC testing and all related activities associated with this testing. The QC Supervisor's responsibilities include, but are not limited to, the direction and development of the QC department with regard to both personnel and testing functions.
Responsibilities:

•Plans, implements and directs core functions of direct reports related to routine testing; provides technical support as well as facilitation of investigations; supports QC operations related to business and manufacturing schedules; support of process validation initiatives; where necessary, tracks and trends key indicators of Quality Control laboratory metrics.

•Coordinates and evaluates employees and responsible for proper administration and adherence to all Biogen policies and procedures.

•Supports the Manager for activities related to interviewing, hiring and training of employees, compliance with training policies, performance evaluations, and supporting resolution of employee-related issues.

•Assesses impact to the documentation and group for vendor change notifications or raw material changes as documented within the change control system.

•Authors or reviews investigational protocols, investigational reports, qualification protocols, and qualification reports.

•Performs (occasionally) routine testing and data review, as needed.

•Performs critical data review and COA generation for Biogen testing.

•Supports the execution of the transfer, qualification, method development, analytical improvement projects, and validation of analytical methods in collaboration with the Analytical Technology/Development group.

•Proactively identifies and addresses technical issues and compliance/technical gaps within the group.

•Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Materials laboratory.

•Provides support for projects, regulatory commitments and regulatory and internal inspections.

•Helps define QC budgetary needs for the department.

*LI-CTL2
LocationResearch Triangle Park, NC, US
Job CategoryQuality
Requisition Number32242BR
Qualifications
•Demonstrated management and leadership abilities.

•Candidates must have experience with raw material testing, knowledge of USP, Ph. Eur and JP testing requirements and regulations, and extensive GMP experience, preferably in a commercial manufacturing environment.

•Excellent time management and prioritization skills.

•Excellent oral and written communication and presentation skills.

•Strong organizational skills.

•Ability to coordinate multiple activities in parallel.

•Demonstrated problem solving and instrument/method troubleshooting skills.

•Strong knowledge of FDA/EMA regulations and compliance.
EducationBiological Science degree is preferred with a minimum of 5 years of relevant experience (MS degree) or 7 years of relevant experience (BS degree). 1-3 years leadership experience; does not have to be in supervisory role, can be lead role.
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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