Executive Director, Biologics Analytical Research & Development
Company: Initial Therapeutics, Inc.
Location: Rahway
Posted on: April 7, 2025
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Job Description:
Our Research Scientists are our Inventors. We identify and
target steps in disease mechanisms or pathways that could be
inhibited or enhanced. Our goal is to isolate a compound that is
effective against a disease target. Using innovative thinking,
state-of-the-art facilities, and robust scientific methodology, we
collaborate to discover the next medical breakthrough.Our team in
Rahway, New Jersey, is seeking an exceptional leader who is
passionate about leading a team of Scientists to deliver analytical
solutions that enable and accelerate process and product
development and manufacturing, ensuring the safety and quality of
our products. The successful candidate will be accountable for
proactive resourcing planning, risk assessment strategies, and will
focus on talent development and partnering to build an integrated
culture of innovation across modalities. They will partner with
cross-functional development teams to enable pipeline decisions.The
Executive Director, Biologics Analytical Research and Development
(B-AR&D) is responsible for providing strategic and technical
leadership for analytical development of candidates from the
discovery interface through first product registration. They will
manage a portfolio of Biologics programs (approximately 10-15
programs) and lead multiple Director-led Development teams,
comprising approximately 40-50 scientists. Strategic partnering
with Biologics Analytical Research and Development method
development GMP laboratories, complementary areas of Analytical
Research and Development, Biologics Process Research and
Development, CMC, and Regulatory in aspects of control strategy and
filings, Quality, and our partners in commercialization and
manufacturing is essential.The successful candidate must function
well and collaborate in a fast-paced, integrated, multidisciplinary
team environment. Research and industry experience should
demonstrate successful application and management of
state-of-the-art analytical techniques to solve problems. This
includes a strong background and experience in separations science,
extensive experience with UPLC/HPLC analysis of biologics (e.g.,
SEC, RP, IEX), experience in microbiological techniques, ELISA,
PCR, cell-based analytics, a background in analytical
methodologies, and sound scientific understanding of Critical
Quality Attributes/QbD/DOE principles, as well as data analysis and
statistics for setting specifications. The incumbent will be
responsible for the recruiting, appraisal, and development of
personnel under their supervision.The Executive Director selects,
trains, and effectively works with colleagues to action development
plans of personnel under their direction within the framework of
Company policy. The Executive Director will be a manager of
managers, with a keen focus on coaching and mentoring
organizational leaders in talent development. The role will also be
responsible for proactive resourcing planning, risk assessment
strategies, and budget management as necessary (including merit and
promotion planning). Maintaining a strong network internally and
across the external academic and regulatory community is expected,
as well as advancing a culture of scientific excellence, compliance
mindset, and collaboration with various partners and stakeholders
in development.Education:
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Keywords: Initial Therapeutics, Inc., Trenton , Executive Director, Biologics Analytical Research & Development, Executive , Rahway, New Jersey
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