Director, Analytical Science and Technology (568)
BioSpace, Topeka, KS, United States
Director, Analytical Science and Technology (568)
1 day ago Be among the first 25 applicants
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 to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one‑third of U.S. hospital beds, have joined Civica. Civica supplies medicines to these members in 49 states and also serves the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile. The organization’s mission now extends to consumers through CivicaScript, which develops quality generic medicines with trusted partners and delivers significant cost savings. A new 140,000‑square‑foot manufacturing facility in Virginia will soon produce more than three dozen sterile injectables and affordable biosimilar insulins. The Civica Foundation, a 501(c)(3) organization, supports these efforts and partners with the diabetes ecosystem to bring affordable insulin nationwide. Civica is leading a patient‑focused movement to eliminate shortages and stabilize high prices.
Learn more at www.civicarx.org
Position Summary This role has end‑to‑end accountability for biologics analytical method development, qualification, and ongoing performance in development and QC labs. The scope covers release methods, functional binding, cell‑based activity assays, and other advanced characterization assays required for biosimilar analytical comparability. The incumbent will manage contract development laboratories, oversee analytical method transfer and optimization, and lead comparability data analysis relative to reference products. Post‑launch responsibilities include ongoing troubleshooting, specification revisions, and analytical support for lifecycle management. The role supports cGMP quality and regulatory requirements for BLA submissions and may be performed remotely, in‑office, or on a hybrid basis.
Essential Duties and Responsibilities
Oversee analytical method transfer, optimization, development, and validation design, including drug substances, drug product, excipients, and residual testing under USP and ICH guidelines.
Work with development partners to create and justify a control strategy and specification rationale for biologics products.
Lead method development, troubleshooting, validation, and execution of advanced binding and cell‑based biologic activity assays for extended protein characterization.
Provide direction to R&D bioanalytical scientists and CDMO partners to execute the development strategy.
Review protocols and ensure that method development, validation, transfer, and optimization meet regulatory requirements.
Collaborate with Regulatory Affairs to prepare documentation for BLA applications supporting biotherapeutic submissions.
Serve as the subject‑matter expert during FDA interactions, defending control strategies and specifications.
Review validation and stability data for method validation reports and stability reports for BLA submissions.
Support USP Compendial testing and other compendial requirements as needed.
Investigate analytical method failures using root‑cause analysis techniques.
Implement corrective and preventive actions for investigational and atypical events.
Consult with scientific professionals and literature for problem‑solving assistance.
Supervise contract development, manufacturing organizations, technology transfer, process validation, and stability testing.
Assist in peer reviews of analytical data from contract laboratories in collaboration with quality assurance.
Perform other duties as required.
Minimum Qualifications
MS preferred, PhD a plus; BS/BA required in chemistry, biochemistry, molecular biology, microbiology, biochemical engineering, or related fields.
Minimum 6 years’ experience as a technical subject‑matter expert and content approver for biologic IND and/or BLA submissions, with the ability to defend content with FDA experts.
Strong experience in analytical development, justification of specifications, and determination of product‑related impurities for protein therapeutics.
Proven ability to lead development partners and specialized bioanalytical characterization laboratories.
Experience with second‑order biophysical characterization assays (mass spectrometry, SEC‑MALS, NMR, etc.) used for biophysical and structural characterization of large molecules.
Deep understanding of typical biologic testing assays, including separation techniques (HPLC, SDS‑PAGE, IEF), cell‑based potency assays, and binding activity assays.
Excellent interpersonal and verbal and written communication skills at all levels.
Strong time‑management, prioritization, and organizational abilities with meticulous attention to detail.
Self‑starter with maturity, independence, and dependability, capable of working in a fast‑paced environment under pressure and multitasking to deliver results.
Physical Demands and Work Environment
Requires up to 25% travel to partner CDMO sites, including international travel to India; remote work is available for non‑travel days.
Typical duties involve frequent talking, hearing, and using hands or fingers to handle tools, objects, or controls; occasional standing, walking, sitting, and reaching with hands and arms are required.
May lift and/or move up to 25 pounds occasionally.
The work environment is usually low to moderate in noise level.
Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
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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 to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one‑third of U.S. hospital beds, have joined Civica. Civica supplies medicines to these members in 49 states and also serves the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile. The organization’s mission now extends to consumers through CivicaScript, which develops quality generic medicines with trusted partners and delivers significant cost savings. A new 140,000‑square‑foot manufacturing facility in Virginia will soon produce more than three dozen sterile injectables and affordable biosimilar insulins. The Civica Foundation, a 501(c)(3) organization, supports these efforts and partners with the diabetes ecosystem to bring affordable insulin nationwide. Civica is leading a patient‑focused movement to eliminate shortages and stabilize high prices.
Learn more at www.civicarx.org
Position Summary This role has end‑to‑end accountability for biologics analytical method development, qualification, and ongoing performance in development and QC labs. The scope covers release methods, functional binding, cell‑based activity assays, and other advanced characterization assays required for biosimilar analytical comparability. The incumbent will manage contract development laboratories, oversee analytical method transfer and optimization, and lead comparability data analysis relative to reference products. Post‑launch responsibilities include ongoing troubleshooting, specification revisions, and analytical support for lifecycle management. The role supports cGMP quality and regulatory requirements for BLA submissions and may be performed remotely, in‑office, or on a hybrid basis.
Essential Duties and Responsibilities
Oversee analytical method transfer, optimization, development, and validation design, including drug substances, drug product, excipients, and residual testing under USP and ICH guidelines.
Work with development partners to create and justify a control strategy and specification rationale for biologics products.
Lead method development, troubleshooting, validation, and execution of advanced binding and cell‑based biologic activity assays for extended protein characterization.
Provide direction to R&D bioanalytical scientists and CDMO partners to execute the development strategy.
Review protocols and ensure that method development, validation, transfer, and optimization meet regulatory requirements.
Collaborate with Regulatory Affairs to prepare documentation for BLA applications supporting biotherapeutic submissions.
Serve as the subject‑matter expert during FDA interactions, defending control strategies and specifications.
Review validation and stability data for method validation reports and stability reports for BLA submissions.
Support USP Compendial testing and other compendial requirements as needed.
Investigate analytical method failures using root‑cause analysis techniques.
Implement corrective and preventive actions for investigational and atypical events.
Consult with scientific professionals and literature for problem‑solving assistance.
Supervise contract development, manufacturing organizations, technology transfer, process validation, and stability testing.
Assist in peer reviews of analytical data from contract laboratories in collaboration with quality assurance.
Perform other duties as required.
Minimum Qualifications
MS preferred, PhD a plus; BS/BA required in chemistry, biochemistry, molecular biology, microbiology, biochemical engineering, or related fields.
Minimum 6 years’ experience as a technical subject‑matter expert and content approver for biologic IND and/or BLA submissions, with the ability to defend content with FDA experts.
Strong experience in analytical development, justification of specifications, and determination of product‑related impurities for protein therapeutics.
Proven ability to lead development partners and specialized bioanalytical characterization laboratories.
Experience with second‑order biophysical characterization assays (mass spectrometry, SEC‑MALS, NMR, etc.) used for biophysical and structural characterization of large molecules.
Deep understanding of typical biologic testing assays, including separation techniques (HPLC, SDS‑PAGE, IEF), cell‑based potency assays, and binding activity assays.
Excellent interpersonal and verbal and written communication skills at all levels.
Strong time‑management, prioritization, and organizational abilities with meticulous attention to detail.
Self‑starter with maturity, independence, and dependability, capable of working in a fast‑paced environment under pressure and multitasking to deliver results.
Physical Demands and Work Environment
Requires up to 25% travel to partner CDMO sites, including international travel to India; remote work is available for non‑travel days.
Typical duties involve frequent talking, hearing, and using hands or fingers to handle tools, objects, or controls; occasional standing, walking, sitting, and reaching with hands and arms are required.
May lift and/or move up to 25 pounds occasionally.
The work environment is usually low to moderate in noise level.
Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
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