Job Opportunity
We are seeking a Biopharmaceutical Manufacturing Expert to provide technical expertise in monoclonal antibody production processes. The successful candidate will demonstrate strong data-driven decision-making and problem-solving capabilities.
Responsibilities:
* Provide technical oversight for monoclonal antibody manufacturing processes, ensuring compliance with regulatory requirements.
* Participate in the resolution of technical issues related to control strategy and manufacturing operations.
* Author deviations and change controls to maintain process validation and qualification.
* Manage internal and external relationships to ensure effective communication and collaboration.
* Bulletin and maintenance of relationships with development and central technical organizations.
* Evaluate and justify the state of validation with data that evaluate the capability of the manufacturing process.
Requirements:
* Bachelors (minimum) in Biotech, Chemistry, Biochemistry, Biology, Pharmacy, or Engineering.
* At least 3 years of experience in biopharmaceutical manufacturing and regulatory expectations.
* Strong understanding of regulatory requirements and their application in a manufacturing environment.
* Demonstrates adaptability and a collaborative mindset.
* Proven ability to effectively communicate and influence across diverse technical teams.
* Demonstrated project management expertise with a track record of coordinating multifaceted projects.