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Senior Analytical Biopharmaceutical Scientist

Company: Civica Rx
Location: Petersburg
Posted on: August 6, 2022

Job 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. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result. Who suffers most? Patients. 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. Led by an experienced team of health care and pharmaceutical industry leaders. Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. 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 Policy for the Civica team has been Do What Is in the Best Interest of Patients. Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs. To find out more about how Civica's innovative model is directly impacting patient care, click below to read a recent article from the New England Journal of Medicine. Video Introduction to Civica: Position Summary The Sr. Analytical Biopharmaceutical Scientist will be expected to supervise, review, design, and assist in the execution of biologic analytical testing and experiments to support the drug development of biopharmaceuticals and biosimilar sterile injectable pharmaceutical products. Under the direction of research and development, you will review and approve protocols, analytical data, method development, method validation reports, analytical method transfer, technical reports, supervise contract testing, and provide technical assessments in support of parenteral product development. Additionally, this role will support cGMP quality and regulatory requirements for BLA product submissions. This job position may be performed remotely, in office, or by hybrid approach. Essential Duties and Responsibilities

  • Provide oversite of analytical method transfer, optimization, and development/validation design. Analytical methods development/validation and stability of drug substances, drug product, excipients, and residual testing, using guidelines from USP and ICH.
  • Support method development/validation using HPLC, UPLC, GC (direct inject/headspace) and ICP-MS as well as other analytical equipment.
  • Work with development partners to develop and own control strategy and justification of specification rationale for biologics products
  • Support microbiological requirements through review, development, and validation in support of product development as required.
  • Develop, author, and review protocols under which the methods development, validation, transfer, and optimization, are conducted.
  • Supports Regulatory Affairs in the preparation and compilation of the necessary documentation to be submitted in the product regulatory filings to support BLA applications.
  • Act as subject matter expert in discussions with FDA, defense of control strategies, justification of specification, and method
  • Review of validation and stability data in support of the method validation report and stability reports for BLA submissions.
  • Reviews, writes, or assists in SOPs, protocols, test methods for analytical development.
  • Review and support of USP Compendial testing and other Compendial testing as required.
  • Review and preparation of certificates of analysis and stability reports.
  • Investigates analytical methods failures by performing root cause analysis techniques.
  • Support investigations and atypical events, as well as resulting corrective or preventive action implementation
  • Works with and consults quality control, raw materials, release, and stability labs to resolve analytical method issues.
  • Consults with scientific professionals and scientific literature for problem solving assistance.
  • Provides analytical testing support for manufacturing process validation.
  • Actively participates in Quality by Design for drug products and Design Control for drug/device combination products.
  • Provides guidance of routine sample processing and dosage form analysis using a variety of analytical instrumentation.
  • Support and supervise the work of contract development and manufacturing organizations, from contract development to technology transfer, process validation, and stability testing.
  • May assist in conducting peer reviews of other analytical data from contract laboratories work in conjunction with quality assurance.
  • Performs other duties as required. Minimum Qualifications (Knowledge, Skills, and Abilities)
    • Bachelor's degree in Chemistry or related scientific field with at least 5 years of biopharmaceutical product analytical chemistry method development/method validation/routine testing experience. cGMP experience preferred.
    • Experience in analytical biological pharmaceutical operations/cGMP environment and performing technology transfer is preferred.
    • Ability to identify and lead development partners and consultants
    • Experience with sterile/parenteral products is preferred but not required.
    • Knowledge of a wide range of pharmaceutical products and processes is preferred.
    • Knowledge of the product development process for biologics/biosimilars.
    • Complex problem solving with the ability to troubleshoot technical issues and provide satisfactory resolution in a timely manner.
    • Ability to work with a variety of technical disciplines.
    • Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
    • Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations.
    • Ability to effectively collaborate with others to achieve team goals and expectations.
    • Effective time management and prioritization skills.
    • Outstanding organization skills and attention to detail.
    • Self-starter, mature, independent, and dependable.
    • Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.
    • Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment. PI

Keywords: Civica Rx, Richmond , Senior Analytical Biopharmaceutical Scientist, Other , Petersburg, Virginia

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