CMC Management & Operations Intern
- Employer
- Daiichi Sankyo
- Location
- Basking Ridge, NJ
- Start date
- Mar 18, 2023
View more
- Discipline
- Manufacturing & Production, Operations, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country
Job Details
- Understand regulatory compliance/requirements of manufacturing clinical and commercialization products.
- Support Tech Transfer of Biologics Manufacturing processes within our company’s internal and external manufacturing network and Potential involvement with all phases of project management
- Work with operations and quality groups to maintain products at a high level of performance/compliance
- Collaborate with cross-functional teams internally and externally to improve and/or optimize CMC related business processes
- Review completeness of documentation to support IND/BLA/MAA submissions
- Understand manufacturing changes to ensure compliance with appropriate change control systems/process and support regulatory filing strategy (PAS, CBE, Annual Reports, etc.)
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Qualified candidates must currently be enrolled in an accredited undergraduate program with a concentration in Chemical, Biochemical, Biomedical or other related Engineering disciplines, Regulatory or pharmaceutical science, or other related fields in science and technology (Chemistry, Biology, Microbiology, Operations Research, Industrial Engineering, etc.) or related field.
- Prior experience in a corporate business environment is preferred; experience in the pharmaceutical industry is a plus.
- Candidates must have excellent academic achievement and analytical thinking ability.
- Candidates should have knowledge of current Good Manufacturing Practices (cGMPs), data analytics experience.
- Candidates should have Pharmaceutical science and manufacturing process unit operation knowledge.
- Candidates should have experience writing, editing, and reviewing scientific publications and content.
- Candidates must have good organizational skills.
- Candidates must have superior communication and interpersonal skills.
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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