Job Description
An exciting opportunity has arisen for a Biologics Drug Substance Specialist, within our Technology Transfer Delivery Team, at a cutting-edge manufacturing facility.
We are a premier biotechnology company that enables and advances innovative solutions. By integrating leading-edge technology with a dynamic workspace, our facility supports seamless connection and collaboration across teams and functions.
The Technology Transfer Delivery group works closely with external stakeholders and internal partners to deliver seamless New Product Introduction to our multi-product facility.
The successful candidate will be responsible for supporting New Product Introduction, acting as a key contributor to the evolving site tech transfer strategy, and driving process improvements.
Key Responsibilities:
* Collaborate with stakeholders to execute the transfer requirements of late-stage clinical and/or PPQ programs.
* Attend meetings with local and international groups to coordinate and execute implementation tasks for new drug substance processes.
* Manage new program introduction schedules to ensure timely execution and right-first-time delivery.
* Develop and deliver GMP documents related to TT, such as risk assessments, change controls, batch records, and sampling plans.
Required Skills and Qualifications:
To excel in this role, you will need:
* A minimum of 3 years of work experience in the pharmaceutical or biotech industry.
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or a related field.
* Technical knowledge of biologics drug substance upstream and downstream operations or process development.
* Understanding of New Product Introduction (NPI) principles and activities.
* Familiarity with automation systems and business tools.
Benefits:
We offer a dynamic and inclusive work environment, opportunities for growth and development, and a competitive compensation package.
Others:
We are committed to 'Inventing for Life' and strive to find solutions for some of the world's most challenging healthcare needs.
If you are ready to drive innovation, impact the future, and inspire your team, please apply today.