About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Position Summary

This individual will have end to end accountability for biologics analytical method development, qualification, and ongoing performance in development and QC labs.  Scope of role is inclusive of release methods, functional binding and cell-based activity assays, and other advanced characterization assays required to demonstrate biosimilar analytical comparability for Civica biosimilars.  This individual will work with the R&D team to manage and oversee contract development laboratories with a focus on the biologic’s analytics methods.  Following product launch, this individual will be accountable for ongoing troubleshooting/method performance, specification revisions, and other analytical support for Civica biosimilars after approval, as part of lifecycle management.  Individual will be accountable for setting an analytical control strategy that is approvable by FDA and will lead development of the comparability data analysis relative to reference products. , 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.
• Work with development partners to develop and own control strategy and justification of specification rationale for biologics products
• Oversee method development, troubleshooting, validation and execution of advanced binding and cell-based biologic activity assays necessary for extended characterization of protein-based therapeutics. 
• Provide direction to R&D bioanalytical scientists and CDMO’s to execute the development strategy. 
• Review protocols under which the methods development, validation, transfer, and optimization, are conducted.
• Support Regulatory Affairs in the preparation and compilation of the necessary documentation to be submitted in the product regulatory filings to support BLA applications.
• Serve as Civica’s subject matter expert in discussions with FDA, defense of control strategies, justification of specification, and method
• Review validation and stability data in support of the method validation report and stability reports for BLA submissions.
• Reviews protocols, test methods for analytical development.
• Review and support of USP Compendial testing and other Compendial testing as required.
• Investigates analytical methods failures by performing root cause analysis techniques.
• Support investigations and atypical events, as well as resulting corrective or preventive action implementation
• Consults with scientific professionals and scientific literature for problem solving assistance.
• 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)

• MS preferred, PhD a plus, BS/BA level collegiate degree required in chemistry, biochemistry, molecular biology, microbiology, biochemical engineering or other related fields to biologics manufacturing
• Minimum 6 years’ experience as technical subject matter expert and content approver for biologic analytical IND and or BLA submissions.  Capable to defend content with FDA subject matter experts, and fluent understanding of analytical development, justification of specification, and determination of product related impurities for protein therapeutics.
• Demonstrated ability to identify and lead development partners and consultants, particularly specialized bioanalytical characterization laboratories
• Has direct experience with 2^nd order biophysical characterization assays including mass spec, SEC MALS, NMR, and other advanced techniques used in to characterize biophysical and structural properties of large molecules. 
• Demonstrates a deep technical understanding of typical biologic testing assays, including but not limited to separation techniques (HPLC, SDS PAGE, IEF), cell-based potencies and bioassays, and binding activity assays.
• Demonstrates a deep understanding of biophysical characterization assays to ensure primary sequencing and structure.  E.G, NMR, mass spectroscopy, etc. Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations.
• Has effective time management and prioritization skills, Outstanding organization skills and attention to detail.
• Is a Self-starter, mature, independent, and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.

Physical Demands and Work Environment

• Requires up to 25% travel to partner CDMO’s, including international travel to India.  Time outside of travel can be conducted as remote-by-design
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.