- Assist selection of parameters to monitor (product on time delivery, yield, deviation rate, on-time investigation closure, etc) (end of Week 2).
- Datamine previously manufactured batches to establish baseline and trends (end of Week 4).
- Assemble data into visual format to communicate baseline and trends. Draft presentation to communicate with vendor and internally (end of Week 6).
- Develop template for tracking of metrics and reporting at project team and JSCs (end of Internship).
- Assist with drafting of request for proposals (RFPs) including mining batch records / reports for detailed manufacturing process information, document formatting, editing and comment resolution (end of Week 2).
- Identify list of potential manufacturing sites (end of Week 4).
- Communicate with potential CMOs to gather initial information including business development contacts, broad facility capabilities and alignment with project needs (end of Week 6).
- Present results to 2nd supplier team with recommendations and justifications for CMOs that should receive RFP (end of Internship).The Intern will also Track daily supply activities and progress of the Clinical Supply Chain.
- Overview of drug development including stages, data points and quality/regulatory oversight (end Week 2).
- General structure of pharmaceutical companies and interaction between different departments (end Week 2).
- Understanding of GMP regulations and how those regulations impact manufacturing processes (end of Internship).
- Exposure to the process of selecting clinical packaging CMOs with a review of current and potential future Vaxcyte CMOs (end of Internship).
- Exposure to supplier contracting, purchase order and invoicing systems (end of Internship).
- Exposure to the daily management of a clinical supply chain, including oversight of planning and distribution systems, internally and at suppliers (end Week 3).
- Detailed insight to management of GMP materials suppliers and establishment of suppliers (end of Internship)
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Summer Intern - San Carlos, United States - Vaxcyte
Description
Join our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning.
Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making
Summary:
Vaxcyte's Summer Internship program offers students with an opportunity to gain valuable work experience that complements their college curriculum with relevant hands-on work that can shape their future career pathing and interests.
As a Commercial Manufacturing and Supply Chain Intern for Vaxcyte, you will be responsible for assisting with establishing KPIs to monitor CMC supplier performance and identifying a secondary supplier for production of GMP materials.
The Intern will:
Program Details:
Internship will begin in June and will be 8-10 weeks (6-8 hours per day) in duration at our San Carlos, California location
Requirements:
Must be pursuing a Bachelor's Degree (enrolled student with at least 1 year at university completed) with a focus on Biology or related subject.
Demonstrates collaboration and teamwork. Enthusiastic - Shows curiosity and is eager to learn.
Dedicated.
Reports to:
Director, CMC Supplier ManagementLocation:
San Carlos, CA
Salary Range:
The expected salary range for this position is $20-$23 per hour. Actual pay will be determined based on year of university/college completed. The Summer Internship position will not be eligible for benefits and relocation and housing will not be offered.
Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070We are an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.