Process Specialist
We are seeking a skilled and experienced Process Specialist to lead our Quality initiatives.
About Your New Role:
* Plan and coordinate Technical Transfer activities to support new product launches and production operations.
* Develop instructions for manufacturing processes such as tableting and packaging.
* Review and report on Technical Transfer activity data and collaborate with the scheduling team to ensure timely execution.
* Support the Manufacturing team throughout the production process and develop necessary protocols.
You will utilize a risk-based approach for planning, readiness, and execution of Technical Transfer activities, developing functional partnerships with site business units to address related issues.
Required Skills and Qualifications:
* A minimum of a Master's degree in a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals).
* A PhD is desirable.
* At least 5 years of experience in the biotechnology and/or pharmaceutical industry, with operational experience in new product introductions and product support.
* Knowledge of pharmaceutical manufacturing processes and equipment (oral solid dose, parenterals, and/or biologicals).
* Experience in authoring, reviewing, and executing process validation studies and reports.
What We Offer:
* Competitive salary and benefits package.
* Opportunities for professional development and career growth.
* A dynamic and collaborative work environment.
* Exposure to cutting-edge technology and processes in the biotechnology and pharmaceutical industry.