Takeda Pharmaceutical Microbiome Development 2022 Summer Intern
Takeda Pharmaceutical Microbiome Development 2022 Summer Intern. Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people’s lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
2022 Summer Intern — Microbiome Development
Job ID: R0055042
Location: Boston, Massachusetts
About the role:
Takeda’s summer 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. Our internship program also provides you the opportunity to network with people at Takeda through various planned events and activities.
Project title: Document management and control for a complex Live Biotherapeutic program (LBP) based on naturally occurring organisms from human gut microbiota.
Rationale: Current LBP project is a complex program based on 30+ naturally occurring live organisms isolated from the human gut. The 30+ strains lead to 30+ each of Master Cell Banks, Working Cell Banks, and Drug Substances (DS). In turn, for each of these items, many documents must be generated before manufacturing can commence and after manufacture is completed. These include Master Batch Records (MBRs), Executed Batch Records, Specifications and Justification of Specifications, Stability Protocols, and Method Qualifications, among others.
Assistance with organizing and uploading these documents into electronic document control systems is requested.
What the intern will learn: The intern will learn Quality Assurance (QA), Introduction to Good Manufacturing Practices (GMP), documentation, and regulatory requirements for drug development, with specific emphasis on requirements for LBPs. They will learn GMP including what is involved in creating MBRs and other crucial documents. The intern will also learn about the complexities of managing a program with multiple drug substances, as well as QA requirements for document dependencies and required sequences of events.
How you will contribute:
- Deadline-driven with a high level of organizational and planning skills
- Strong analytical, problem-solving, and oral and written communication skills; he or she also has the ability to work well in teams, effectively manage projects, and present ideas clearly and concisely.
- Global mindset to grow in a diverse work environment
- Excellent communication and leadership skills
- Strong attention to detail, strong organizational skills, comfort with interacting with computers and software
What you bring to Takeda:
- Must be authorized to work in the US on a permanent basis
- Must be available full time (40 hours/week) a minimum of 12 weeks during the Summer months
- Minimum GPA 3.0/4.0
- Undergraduate, Graduate, PhD, MD student with at least one year of university studies before internship.
- Pursuing degree in one of the following fields: Chemical Engineering, Bioengineering, Microbiology, or other related fields. We will also accept other majors, even non-STEM majors, so long as the intern has good organizational skills and an interest in Drug Development.
- Return to university for at least one semester post-internship
- Takeda does not provide student housing or housing stipends
Salary & Location:
- Intern pay rate ranges are from $18/hour to $45/hour, depending on students level in their undergraduate or graduate program and level professional experience.
- Location is COVID-19 dependent, remote applicants may apply.