Head of Biologics Development and Technology-Drug Substance

Company: Civica RX
Location: Petersburg
Posted on: November 17, 2023

Job Description:

This individual has accountability to oversee and deliver all technical activities for the end-to-end development lifecycle of recombinant drug substance in support of Civica biosimilar programs.-- The scope of the programs includes affordable insulin, as well as future biosimilars. The successful candidate will work through development partners and CDMO's to ensure all aspects of the drug substance process development and manufacturing, from host selection through final Drug Substance, are completed according to cGMP and Quality by Design principles.-- --For new products, this individual will partner with Civica Business development, Quality, and Executive Leadership to identify and secure agreements with potential CDMO's, and explore existing technology platforms related to biosimilars. --This leader will have full lifecycle accountability from initial development through post-approval changes.
Civica is a non-profit, not for stock corporation focused on doing what's in the interest of patients and ensuring a robust supply of affordable medicines in the US.-- This is an exciting, technical leadership opportunity with a novel non-profit manufacturing startup.-- The role is remote by design, and involves up to 35% travel.
Essential Duties and Responsibilities:

Accountable as technical subject matter expert for all drug substance process development and manufacturing information supportive of the Biologics Licensing Application (BLA)
Provide input to selection of drug substance Contract Development and Manufacturing Organizations (CDMO) to Civica Executive team.
Manage and oversee the delivery of process development and characterization activities to ensure a robust, efficient process is developed and approved by US FDA.
Act as accountable person for all drug substance related sections of the CMC dossier for IND and BLA filings with health authorities
Ensure robustness and quality of drug substance
Work with DP development team to ensure drug substance input material meets requirements
Will act as individual contributor working through CDMO's at first but may build/manage a small team of scientists/engineers to enable program delivery.
Work with CDMO project management and Civica program management to build tech transfer and startup schedules, and carefully manage schedule adherence.--
For startup sites, work directly with general management and staff to recommend and implement operational improvements.----
Basic Qualifications and Capabilities:

Minimum 10 years experience, with experience in supporting BLA-enabling process development.-- Experience with Drug Substance development IND and BLA support, with biosimilar experience a plus--
Experience in Quality and Operations organizations within GMP manufacturing
MS preferred, PhD a plus, BS/BA level collegiate degree required in bioprocess engineering, chemical engineering, biology, microbiology, or other related fields to biologics manufacturing. --
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Keywords: Civica RX, Richmond , Head of Biologics Development and Technology-Drug Substance, IT / Software / Systems , Petersburg, Virginia