Takeda's internship program blends real world experience with an extensive overview of the pharmaceutical industry. Knowledgeable mentors will provide guidance as you gain professional hands-on experience. The summer internship program is 12 weeks in length and offers a unique perspective into a world-class pharmaceutical company. Compensation is competitive, and financed temporary housing is available to those who qualify. Our internship program also provides you the opportunity to network with people at Takeda through various planned events and activities.
The purpose of this position is to gain practical experience in the fields CMC (chemistry, manufacturing and controls) as they relate to the overall drug development process. The position will entail working in the Pharmaceutical Science Product Development group with significant interaction with related functional groups. The position shall provide the individual with an understanding of FDA/ICH regulations and guidance for CMC documents for drug substance and drug product R&D, clinical supplies manufacturing, manufacturing technical support with an emphasis on GMP and experience critically reviewing the basic chemical/physical properties of various drug candidates. These objectives will be achieved under the supervision and guidance of CMC Manager(s) and product development team members, as appropriate.
- Execute and present the findings of a primary project that is assigned at the commencement of the internship
- Provide input into documents related to the drug development process, including Investigator Brochures, IND's, and NDA's
- Interface with various disciplines (Statistics, Clinical Research, Clinical Operations, Project Management, Regulatory, Quality Assurance) and all personnel directly or indirectly involved in the effective management of drug product development.
- Learn applicable regulations and guidelines that govern clinical and commercial supplies (i.e. FDA and ICH guidelines)
- Participate in cross-functional team meetings
- Assist in the review of published scientific literature and drug development/delivery technologies
- Assist in the review compilation and analyses of experimental results and laboratory data
EDUCATION, EXPERIENCE, KNOWLEDGE, AND SKILLS
- Enrolled in a U.S. accredited university
- Must have completed his/her sophomore year
- Pursuing either a B.S. (majoring chemistry, biology or pharmacy) or enrolled in PharmD program
- Superior communication skills: written, oral, interpersonal and presentation
- Excellent problem solving and analytical skills.
- Previous university pharmacy program experience
- Science Knowledge - possesses the necessary science education and knowledge to learn to be able to initiate clinical manufacturing, packaging and testing programs under GMP
- Product Knowledge - rudimentary understanding of the medical/therapeutic characteristics of drug products
- Pharmacy Knowledge - Basic pharmacology, therapeutics and concept of clinical trials
- Pharmaceutics Knowledge - ability to recognize the importance of formulation design and an understanding of the scientific data required to support formulation development
- FDA Familiarity - ability to learn and apply applicable regulations, current Good Manufacturing Practices, and ICH Guidelines
We are driven to improve people's lives.
- Excellent communication skills
- Ability to prioritize work to effectively meet timelines
- Analytical skills - understanding of analytical chemistry or other technical issues, and determine the cause and possible solutions to the problem
- Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to team goal achievement
- Mastery of MS Word, Excel and data analysis packages
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 19 months ago