Program Lead CMC

Summary

The qualified candidate will provide knowledge-based leadership, coordination and management of global and regional CMC development teams (CMC subteams) across the Daiichi Sankyo organizational matrix for multiple early and late phase drug development candidates. The candidate will represent CMC development teams on global and regional cross-functional drug development project teams with both a strategic and operational focus and will liaison with global and regional senior management within the Global Pharmaceutical Technology Unit. Responsibilities also include providing project management and operational oversight of vendors (CXO) involved in activities that cover the range of pharmaceutical development functions. CMC development teams are accountable for the coordination and management of global and regional development candidates in both early and late phase drug development and will deliver on the project goals according to agreed upon timelines. This position requires a solid technical understanding of drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical methods development and validation, technology transfer and scale-up, process characterization and validation, clinical and commercial supply operations, and CMC regulatory and GMP compliance requirements. This position will identify, recommend and facilitate the implementation of improvements in the operational efficiency of CMC development teams across the Daiichi Sankyo organizational matrix in the Pharmaceutical Technology Department. This position will require moderate supervision.

Responsibilities

- Operational coordination and management of global and regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates and to facilitate the establishment of integrated global and regional CMC operational plans and oversee their execution.

- Represent CMC development teams on global and regional cross-functional drug development project teams with a predominantly operational focus, ensure alignment of CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions.

- Provide project management and operational oversight of routine vendor (CXO) services, managing contracts, timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing and analytical testing services.

- Facilitate regional process improvement, identifying and recommending improvements in the operational efficiency of the Pharmaceutical Technology Department; participate and facilitate on cross-functional teams responsible for implementing process improvements.

- Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development operational teams for early phase projects.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- PhD in biochemistry, (bio) chemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences with a minimum of 3 years industrial experience preferred or

- Master's Degree with a minimum of 5+ years industrial experience preferred or

- Bachelor's Degree with a minimum of 7+ years industrial experience required

Experience Qualifications

- 4 or More Years experience in the pharmaceutical/biotechnology industry working in a drug development environment required

- 1 or More Years experience as a matrix lead of a CMC development teams for drug development candidates and representing those teams on cross-functional drug development project teams, or equivalent. preferred

- Experience in biologics processing, product or analytical development activities and knowledge of CMC regulatory requirements is required.

- A working knowledge of the roles, responsibilities, and operational requirements of all functions represented on CMC development teams. required

- Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional team environment. required

- Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment. Required.

- Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans required

- Experience in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate. preferred

- Experience in the process development, characterization, validation of Antibody Drug Conjugates (ADCs) and monoclonal antibodies is required.

- Experience working within a global matrix organization. preferred

Travel

Ability to travel up to 20% Communications (electronic and teleconference/video-conferencing) across all global time zones, global and domestic travel required.