This listing was posted on PrismHR Hiring.
Senior Bioanalytical Scientist (524)
Location:
Petersburg, VA
Description:
About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.Learn more about Civica’s plans and progress at www.civicarx.org About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica has recently begun to commercialize biosimilars to ensure affordability, starting with a commitment to develop and launch affordable insulin vials and pens at transparent, low prices. Essential Duties and Responsibilities: The person in this role must be able to evaluate analytical results for scientific merit and cGMP compliance, critically review analytical method validation documents, participate in GMP laboratory audits, and manage and store data per FDA requirements. This position requires management of analytical activities at contract development and manufacturing organizations (CDMOs) to enable development and approval of new biosimilar insulin products at Civica. This position requires a person with the ability to interact effectively with people of diverse backgrounds and organizational roles while working from a remote location. Effective verbal communication including excellent listening skills are required. The person in this role must make accurate technical decisions with support from colleagues, while providing direction and oversight for contract laboratories or partner organizations. The person in this role must be proactive regarding timelines and manage expenditures wisely. Finally, this position requires the ability to write technical documents for regulatory filings with FDA. Basic Qualifications and Capabilities: Experience working in a Quality Control role supporting development of biologic products is required. Technical and regulatory document writing ability and effective verbal/listening skills are also required. Technical understanding of drug substance impurity (ie host cell proteins, host cell DNA) method development, validation, and testing to current FDA and industry expectations is preferred. Technical expertise and experience with cell-based and binding (SPR) bioassays for biologic product development is also preferred. Experience with development and qualification of mass spectrometry and other biophysical characterization methods would be an added qualification but is not central to this position. Ideally, the candidate would also have experience and personal knowledge of FDA expectations for analytical studies required for biosimilar BLA filings. Preferred Qualifications: A minimum of 6 years experience in a Quality Control role supporting biologics product development is required. 8 years experience is preferred. Technical understanding of drug substance impurity (host cell impurity) method development and/or similar experience and expertise in bioassays (cell-based and binding) is preferred. A minimum of a Master’s degree in Chemistry, Molecular Biology, or related technical field. Physical Demands and Work Environment: Position is remote with 40% travel required. Position: #524
Company:
Civica Rx
Posted:
May 6 on PrismHR Hiring
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More About this Listing: Senior Bioanalytical Scientist (524)
Senior Bioanalytical Scientist (524) is a Science & Pharmaceutical Scientist Job at Civica Rx located in Petersburg VA. Find other listings like Senior Bioanalytical Scientist (524) by searching Oodle for Science & Pharmaceutical Scientist Jobs.
Senior Bioanalytical Scientist (524) is a Science & Pharmaceutical Scientist Job at Civica Rx located in Petersburg VA. Find other listings like Senior Bioanalytical Scientist (524) by searching Oodle for Science & Pharmaceutical Scientist Jobs.