ASU announces Biodesign Center in China
Author Archive: AZBio
Safeguard Scientifics Appoints Mara G. Aspinall to its Board of Directors
Aspinall joins Safeguard with a track record of success as an entrepreneur and healthcare industry visionary
Arizona Bioscience Votes
Whether you are mailing in Early Voting Ballots or planning to vote at the polls, it is important to exercise your right and privilege to vote.Continue reading
Help Inspire Our Next Generation of Scientists as a Mentor
Mentors are needed for the Student Research Program which is part of the Scientific Enrichment Program for Students (SEPS) administered by the Neurology Research Laboratory of Barrow Neurological Institute of St. Joseph’s Hospital and Medical Center.Continue reading
Job Alert: Supervisor, Environmental Control at Celgene
Posting Title: Supervisor, Environmental Control- 3rd Shift- Phoenix, AZ
Celgene Corporation, recently declared “The #1 Employer in America” by Business Insider, continues to grow! We are a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries – and growing – we look for talented people to grow our business, advance our science and contribute to our unique culture.
Our Phoenix manufacturing site has a need for an experienced Supervisor, Environmental Control for our 3rd shift. supervises and oversees the activities and personnel in the QC Microbiology Environmental control group as they perform routine and non routine Environmental Monitoring of Classified areas, Aseptic Area personnel, and Critical Utilities.
EDUCATION/EXPERIENCE REQUIREMENTS
- Requires a Bachelors degree in Microbiology or related science from an accredited college or university with a minimum of 5 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment with at least 5 years direct experience in Aseptic Processing Environmental monitoring.
- An equivalent combination of education, experience and training may substitute.
Celgene Corporation offers an outstanding total rewards package, including base salary/annual bonus/equity (company stock) and a competitive benefit plan (401k match, etc.).
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S
Please see the full details for this opportunity at:
Job Alert: Analyst, Quality Control-Microbiology (Enviro) at Celgene
Posting Title: Analyst, Quality Control-Microbiology (Enviro) 3rd Shift
– Phoenix, AZ
Celgene Corporation, recently declared “The #1 Employer in America” by Business Insider, continues to grow! We are a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries – and growing – we look for talented people to grow our business, advance our science and contribute to our unique culture.
Our Phoenix manufacturing site has a need for an experienced Analyst, QC- Environmental Microbiology for our 3rd Shift. This position works both independently and with the team to perform routine and non-routine microbiological testing and Microbiology laboratory maintenance functions.
EDUCATION/EXPERIENCE REQUIREMENTS
- Requires a Bachelors degree in Microbiology or related science from an accredited college or university with a minimum of 4 years related experience in a regulated laboratory, preferably in a pharmaceutical laboratory environment.
- An equivalent combination of education, experience and training may substitute.
Celgene Corporation offers an outstanding total rewards package, including base salary/annual bonus/equity (company stock) and a competitive benefit plan (401k match, etc.).
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S
Please see the full details for this opportunity at:
Job Alert: Senior Scientist- Validation at Celgene
Title: Senior Scientist- Validation (Technical Services)- Phoenix, AZ
Celgene Corporation, recently declared “The #1 Employer in America” by Business Insider, continues to grow! We are a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries – and growing – we look for talented people to grow our business, advance our science and contribute to our unique culture.
Our Phoenix manufacturing site has a need for Senior Scientist- Validation (Technical Services). This position develops all qualification/validation approaches (risk/science based) and provides the scientific rationale documented in protocols and summary reports (including conducting research into industry standards/FDA guidelines), prepares project schedules, heads up project teams, executes validation studies, and performs data analysis. Primary responsibilities include the following: Process Validation (Process Performance Qualification), Equipment PQ, Continual Improvement Projects, Cleaning Validation and Validation of Single Use Systems.
EDUCATION/EXPERIENCE REQUIREMENTS
• Requires a Bachelor’s degree in Science or Engineering from an accredited college or university with a minimum of 6 years related experience, with at least 2 years validation experience in a pharmaceutical or related industry.
• An equivalent combination of education, experience and training may substitute.
Celgene Corporation offers an outstanding total rewards package, including base salary/annual bonus/equity (company stock) and a competitive benefit plan (401k match, etc.).
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S
Please see the full details for this opportunity at:
Dr. Timothy Franson joins Critical Path Institute Board of Directors
The Critical Path Institute (C-Path), an independent, non-profit organization that works to advance medical product innovation and regulatory science, announced the appointment of Timothy Franson, M.D., to its board of directors.Continue reading
MeMD’s Virtual doc visits ensure victims’ privacy is protected
SHARE THE HEALTH: Free WebCam Health Checks For Local Domestic Violence Victims
Add YOUR Voice to the FDA PDUFA VI Negotiations
In August, the Biotechnology Industry Organization (BIO) announces a first-of-its-kind survey tool on FDA/Sponsor Interactions During Drug Development to better inform policy initiatives designed to improve FDA and drug sponsor coordination and communication during drug development. This will serve to inform the next reauthorization of the Prescription Drug User Fee Act (PDUFA VI), which will begin in late 2015 with final enactment expected in 2017.
“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI,” said John Maraganore, PhD, CEO of Alnylam Pharmaceuticals and Chair of BIO’s Emerging Companies Section Governing Board.
Survey responses will help assess FDA-sponsor interactions during drug development and address problems, particularly those that result from inconsistencies between review divisions.
The survey will focus on individual clinical programs for products that are in the pre-clinical testing phase through the clinical testing phase, prior to submission of an initial NDA/BLA, and responses will be held strictly confidential, blinded, and aggregated.
Sponsor input will help identify areas where policies, regulations, and practices are working well and should not be changed; and identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective.
Participants will have access to the survey tool 24 hours a day, seven days a week so that responses can be updated on a continual basis. The survey is open to all biopharmaceutical representatives regardless of membership within BIO. Participants will be provided with an annual report on the survey results and invited to join exclusive BIO webinars to discuss survey results with industry leaders and regulatory experts.
The survey can be accessed at https://fdasurvey.bio.org.
Dr. Maraganore discussed the upcoming PDUFA VI reauthorization in a recent BIO Buzz Center video interview that can be accessed here.