Senior Director, Drug Product Development (Small Molecules)

Responsibilities

• This role is responsible for the design, optimization, and manufacture of phase-appropriate small molecule drug products to support non-clinical (Discovery support, animal safety studies) and clinical development programs (Phase 1 to commercial).  The role also has responsibility for line-of-sight to commercially viable manufacturing processes, including selection of appropriate container closure systems.
• The role will also provide technical expertise and guidance regarding pre-formulation activities for internal scientists within Scorpion Discovery teams to enable in vivo evaluation of lead compounds by providing.
• This role will include travel to CDMO sites as required for project meetings, due diligence activities and manufacture.

Key aspects of the role are:

• Key member of Project Development Teams, collaborate and partner closely with CMC project management, drug substance SMEs, DMPK/toxicology, clinical operations, regulatory and quality
• Execute physico-chemical characterizations, chemical stability assessments, and pre-formulation development activities for small molecule lead compounds
• Lead and manage outsourcing activities (formulation/product development and manufacturing) at global CDMO sites, in alignment with program goals
• Design drug product R&D and cGMP stability studies to support product development
• Act as key product SME for the successful execution of technology transfer of drug product processes to manufacturing site(s), providing technical input/insights to the CDMOs
• Create, review, and approve specifications, batch records and other critical development/cGMP documents
• Author, review, and complete drug product sections of regulatory documents (IND, IMPD)
• Foster strong team spirit and promote knowledge exchange within and between teams
• Support Discovery with evaluation of dosing solutions, stability studies, outsourcing activities and evaluate novel formulation technologies to assure the most appropriate delivery of compounds for in vivo studies
• As a part of the CMC development team, evaluate and select the most suitable physical forms of compounds entering development and define formulation strategies for successful transfer from Discovery to Development
• Contribute to evaluation of new scientific technologies and various innovative initiatives within the team
• Report and present scientific/technical results internally and contribute to publications, presentations and patents

Qualifications

• Degree in Pharmaceutical Sciences, Chemistry or Engineering with at least 10 years of life sciences industry experience
• Expertise in phase-appropriate formulation development and manufacture
• Knowledge of current Good Manufacturing Practices and experience in leading manufacture under cGMP
• Strong verbal, written and communications skills as well as a collaborative spirit are essential
• Direct experience of interactions with CDMOs and manufacturing operations
• Proven success working in cross-functional teams
• Strong scientific background and knowledge of the drug development process
• Experience in the application of scientific tools such as design of experiments (DoE) to facilitate efficient drug development
• Skill in fostering open communication, mutual understanding, and cooperation
• Strong understanding of productivity tools, Power Point, Excel, Word along with other related software
• Experience in managing multiple programs at one time, can work well with different management styles to keep a project moving
• Competency in developing, implementing, and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints
• Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a cross- functional team environment
• Experience in developing and commercializing drugs for oncology is an advantage