Senior Director, Drug Product Development (Small Molecules) Boston, MA - Tbwa Chiat/Day Inc

Senior Director, Drug Product Development (Small Molecules)

Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.

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.
• 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.

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.