Vincerx is seeking an experienced, passionate, and impactful
individual to lead the chemical process development,
implementation, and management of robust, cost effective, and safe
processes for the manufacture of APIs from the research stage,
through clinical development and marketing approval.
It is a highly visible role that is integral to the advancement
of Vincerxs growing portfolio of drug candidates and will provide
technical oversight for all small molecule drug substance
development related activities. The individual will represent
chemical development on project teams and collaborate closely with
other functions including analytical and formulation development,
non-clinical development, quality, regulatory, and supply chain to
support program transition from clinical candidate through clinical
development phases to NDA and commercialization.
PRINCIPAL ROLES / RESPONSIBILITES:
Provide strong scientific leadership to ensure timely and
innovative process development and scale-up of drug substance
incorporating quality, safety, compliance, cost efficiency,
sustainability, and reliability to meet development requirements
Direct outsourced chemical development activities in a virtual
environment both domestically and internationally Oversees the
development and transfer of starting materials, intermediates, and
drug substance manufacturing processes to CDMO partners Participate
in vendor selection process supporting Drug Substance Manufacturing
at CMOs, and the building of a resilient supply chain Oversee
contract development and responsible for the technical management
of third-party drug substance manufacturers Oversight and direction
of GMP production activities at contract CDMOs, including review
and approve master batch records, executed batch records,
manufacturing deviations, investigations and Change Control
Participation in the preparation of technical reports, data
summaries and CMC related documents required for various regulatory
submissions including IND/IMPD/NDA/BLA/MAA Travel as required to
CDMO, CRO and key vendor sites to represent Vincerx for
Manufacturing oversight and partnership development purposes.
Provide on-site technical support on an as-needed basis to oversee
various manufacturing campaign activities. Provide technical
expertise to troubleshoot manufacturing process issues Work closely
with analytical, bioassay, QC and QA partners to assess product
quality and product stability Provide organizational leadership in
all areas related to process development Partner with key functions
including Quality, Project Management, Clinical Operations,
Preclinical, Pharmaceutical Development, Finance and Regulatory
Subject matter expertise in process chemistry. Experience in
late-stage development is preferred, i.e., registration
manufacturing and process validation.
The candidate must be highly self-motivated, demonstrate
exceptional leadership, possess strong experimental skills
Excellent written and oral communication abilities Collaborate
effectively on multidisciplinary teams and be able to demonstrate
flexibility in adapting to change in a fast-paced, dynamic research
Remain current with the latest synthetic methodologies Drive
innovation, actively apply new concepts to continuously improve
process chemistry capabilities and expertise, and be active in the
external scientific community via collaboration, publications, and
external presentations Ability and track record of successfully
working in cross-functional teams to progress projects as a
representative of the CMC team in a regulated environment Ability
to multitask and be successful in a fast-paced, matrixed work
environment Desire to be a part of a highly innovative company
aimed at helping patients with serious diseases Once safe to do so,
this individual must be able to travel frequently when needed.
EDUCATION / TRAINING:
PhD in synthetic organic chemistry.
12+ years of experience in pharmaceutical research, development,
and manufacturing in the life science industry.
5+ years of experience in a leadership role responsible for process
development, process characterization, process validation and
product life cycle management.
Competitive compensation and stock options.
100% employee and dependent premiums paid for medical, dental, and
10 company-wide holidays with two floating holidays per year.
Flexible vacation policy with up to 4 weeks per year of paid
Company paid group life and disability insurance.
At Vincerx, we are passionate about our work family. Weve
pledged to create an open, aware, and accepting workplace and, by
extension, a responsive, innovative, and successful company.
Vincerx is an organization dedicated to delivering training and
other resources to help employees, at all levels, feel a sense of
belonging and support and achieve their full potential.
We are determined to address biases and inequities that may
exist in our industry. We believe our focus on diversity and
inclusion will enable us to further strengthen our unique and
collaborative culture, continue to enhance employee engagement and
satisfaction, and drive innovation and improved performance. Our
diversity is our strength and sets us apart from many
We lead with respect, humanity, integrity, and inclusion.