QC Stability Program - Intern

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Date: Sep 16, 2022

Location: San Diego, CA, US

Company: Wacker Chemie AG

 

Our world needs ideas! As one of the world’s most research-intensive chemical companies, we have been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 14,300 employees from 70 nations.

 

Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

 

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications.  At our San Diego site, we are currently looking for a ​QC Stability Program Intern​.

***************************INTERNSHIP IS ON SITE LOCATION IN SAN DIEGO*******************************

The QC Stability Program Intern will be responsible for the following:
Stability Program
Develop a more automated, efficient, and flexible stability program(s) to support both GMP and non-GMP materials, requiring minimal input to initiate, manage and trend new stability studies.    
Develop a straightforward database to track and trend stability data and extrapolate expiration dates.
Setup a system to track stability time points and alert analysts when and what testing is required. 
Gather an understanding of the International Conference on Harmonization of    Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Stability requirements, Guidance Q1A(R2), Q1D, and Q1E, to ensure stability program meets all guidelines.
Generate a stability report template that is flexible for multiple clients.

 

Project Objectives:
Reduce QC analyst time spend on stability data entry, trending, and scheduling.

We are looking forward to your online application!

Reference Code: 16562 

 

 

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.

In accordance with the Internal Placement Policy, you must be in your current role for at least one year, and must inform your current supervisor prior to applying for a new position.  If you have any questions or concerns, please contact your local HR department.

A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.  Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

 

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.


Nearest Major Market: San Diego