OBJECTIVE / PURPOSE:
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 Vincerx’s 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 Affairs
- 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 environment.
- 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
- Must be able to travel frequently when needed.
EDUCATION / TRAINING:
PhD in synthetic organic chemistry with > 12 years of experience in pharmaceutical research, development, and manufacturing in the life science industry, with > 5-year experience in a leadership role responsible for process development, process characterization, process validation and product life cycle management