Head of Biologics Development and Technology-Drug Substance
Company: Civica RX
Location: Petersburg
Posted on: November 17, 2023
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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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PI07094ba6e4b1-25660-33260180
Keywords: Civica RX, Richmond , Head of Biologics Development and Technology-Drug Substance, IT / Software / Systems , Petersburg, Virginia
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