Associate Director CMC Management and Operations
- Employer
- Daiichi Sankyo
- Location
- Basking Ridge, New Jersey, United States
- Start date
- May 21, 2019
View more
- Discipline
- Manufacturing & Production, Operations
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Pharm Country
Job Details
With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
Job 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 CMC functions. A successful candidate will play a key role in developing junior members of the CMC team.
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
1. 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.
2. 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.
3. 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.
4. 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.
5. Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development operational teams for early phase projects.
Qualifications
Education
Ph.D. in biochemistry, (bio) chemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences with a minimum of 5 years industrial experience, or a corresponding Master's/Bachelor's degree with a minimum of 7 years industrial experience
Experience
The following is required:
- At least 5 years of experience in the pharmaceutical/biotechnology industry working in a biologics drug development environment
- Experience in biologics processing, product or analytical development activities and knowledge of CMC regulatory requirements.
- A working knowledge of the roles, responsibilities, and operational requirements of all functions represented on CMC development teams.
- 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.
- Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment.
- Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
- Experience in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate.
- Experience in the development of Antibody Drug Conjugates (ADCs).
- Experience working within a global matrix organization.
Job Title
Associate Director CMC Management and Operations
City
Basking Ridge
Functional Area
Pharma Technology
State
New Jersey
Company
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
For more information, please visit: www.daiichisankyo.com.
Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.
STOCK EXCHANGE: Tokyo Stock Exchange
STOCK SYMBOL: 4568
- Website
- http://www.daiichisankyo.com/
- Phone
- (908) 992-6400
- Location
-
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States
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