Senior Biopharmaceutical Specialist
We are seeking an experienced professional to take on a pivotal role in our biopharmaceutical innovation unit. This position offers a unique opportunity for career growth and development.
Key Responsibilities
* Laboratory Operations Management: Oversee equipment qualification, documentation generation, and subject matter expert review of standard operating procedures and work instructions, contributing to laboratory and process establishment.
* Data Analysis and Reporting: Analyze laboratory data to support batch release, maintain oversight of review metrics, and collate quarterly and yearly reports.
* Inventory Management: Maintain and release laboratory stock, ordering consumables as required.
* Collaboration and Communication: Participate in functional meetings, lead departmental and cross-functional meetings, and ensure effective communication among team members.
* Audit and Inspection Readiness: Support internal and external audits and inspections, ensuring permanent inspection readiness.
* Safety and Culture Enhancement: Drive site safety and promote a positive, respectful culture that values diversity.
* Good Manufacturing Practice Activities: Perform troubleshooting, execute in-process and drug substance analysis studies, and participate in laboratory projects.
* Innovation and Methodologies Implementation: Introduce novel solutions, collaborate with the global Microbiology Center of Expertise, and participate in lean laboratory methodologies.
Requirements and Qualifications
* Qualifications: A degree in Biological Sciences or Engineering, preferably with a background in microbiology; an Advanced Degree (e.g., MSc) is desirable.
* Experience: 3+ years of experience in a relevant industry field, with technical knowledge of biologics drug substance manufacturing and microbiological testing techniques.