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Qc Stability Manager Sr Manager Contractor Bay Area details visit 09/02/2010 Company name: Inspiration Biopharmaceuticals
Job code: INBI-1004
Required education: Bachelor's Degree
Position type(s): CONSULTANT, CONTRACTOR,
Skills required / desired: Quality Control
Description:
Position: QC Stability Manager/Sr. M
anager
Reports to: Director of QC
Description: The QC Stability Manager reports to the Director of QC and is primarily responsible for stability program establishment, stability program management, stability data review and trend evaluation for multiple recombinant coagulation factors (complex proteins) for the company, contract laboratories, CMO's and external partners.
Job Responsibilities
. Stability program evaluation and establishment
. Stability program management
. Stability data review and trend analysis
. Stability protocol and report generations
. Stability database evaluation and assessment
. Participate in release and stability method troubleshooting and resolution
. Provide consultation to stability-indicating method qualification & validation
. cGMP compliances for QC stability program and related activities
. Support QA systems and processes related to QC stability and data review
. Support Regulatory Operations for eCTD submissions, including data retrieval for submissions, data integrity of submissions, and trend statistical analysis
Requirements:
Experience and Background
. Requires a BS/BA, MS or Ph.D. in Biochemistry or equivalent scientific discipline
. Minimum of 8 years' previous experience with QC stability program establishment and/or management in a pharmaceutical chemistry, quality control and/or laboratory positions
. Familiar with cGMP, USP/EP, and FDA/EMEA regulations for biopharmaceutical products
. Working experience with blood coagulation products and/or protein/enzyme products
. Solid knowledge and experience using computer-based statistical analysis and data reporting, and trending packages
. Must maintain comprehensive proficiencies with Microsoft Office and associated applications.
About Inspiration Biopharmaceuticals
Inspiration Biopharmaceuticals was founded in 2004 with the mission to revolutionize treatments for Hemophilia. The Company is focused on developing products that have the potential to broaden patient access to therapy, including prophylactic use. Greater access and more frequent prophylactic therapy have been shown to reduce complications of the disease and enhance patients' long-term health and quality of life. Underlying the Company's programs is a novel, proprietary manufacturing technology that allows a greater yield of high-quality protein. Inspirations' lead product candidate, IB1001 is an intravenous recombinant factor IX product for the acute and preventative treatment of bleeding in patients with hemophilia B. With over 130 years of combined management experience in commercializing hemophilia products at firms such as Baxter and Bayer, Inspiration has been able to rapidly and efficiently develop protein therapeutics for hemophilia.
Please see additional information at www.inspirationbio.com
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Cystic Fibrosis Drug Discovery Charlestown Ma details visit 08/31/2010 Non profit laboratory performing HTS for CF is looking for scientists, or students with a direct personal interest in Cystic Fibrosis to contribute in any capacity to our program.
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
Technology And Patent Literature Research details visit 08/31/2010 Immediate, Part-time, Virtual: Use your interest, knowledge, and research skills to earn between $5,000 and $50,000 per research project. Earn potential rewards for uncovering scientific technical documents and develop valuable research experience.
Ar
ticle One Partners is the world’s largest patent research community. Article One posts requests for articles, patents, research papers, product literature, or any publicly available document in any language from anywhere in the world that describes particular technologies as of a specific date. These research postings are called Patent Studies, and the requested information is known formally as prior art.
Article One’s global research community submits prior art in response to the posted Studies. By researching and submitting prior art, Article One’s registered members or Researchers become eligible to receive the stated reward. Rewards are distributed when Article One determines that a Researcher’s submission best matches the requirements of the Study as stated in the Study description.
Anyone can join Article One’s global research community. Register as a Researcher at http://www.articleonepartners.com and begin working on these and other Studies:
• Two-Sided Printable Media ($5,000)
• Method of Manufacturing: Semiconductor Devices ($5,000)
• Data Processing Device: Semiconductor Chip ($5,000)
• Adding Function to a Web Page ($10,000)
• Communication of Selected Information ($20,000)
• Hydraulic Gear Pump Having Sound Absorption Cavities ($15,000)
• Dynamic Power Management Device ($10,000)
• Wireless Device: Multi-Function Communicator ($5,000)
Article One will review all submissions and inform you if you have earned the stated reward. Your active participation on Article One will earn points for profit-sharing, as described on our website.
For more information or to register as a Researcher, visit http://www.articleonepartners.com
When registering, please enter the referral code “craig.”
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