The selected candidate will be responsible for the primary following activities :
* Guide the team and facilitate collaboration with colleagues at the local site across the global network to shape and implement next-generation technologies with innovations for GMP Batch and Continuous Manufacturing in Drug Substance and Drug Product
* Serve as a subject matter expert in assessing innovative equipment to enhance manufacturing processes, including the development of user requirements and preparation of capital investment proposals
* Strive to align technologies across batch and continuous manufacturing to enable seamless flexibility in transitioning between both approaches
* Support the development of GMP Documentation such as : Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs
* Deliver QA and GMP compliance expertise while collaborating with global, cross-functional teams
To be considered for this position, the ideal candidate must have :
* A minimum of 5 years of work experience in the pharmaceutical or biotech industry
* Minimum of 3 years of experience with quality management and compliance systems, Working knowledge of quality auditing - preferred.
* Familiarity with Upstream and Downstream Unit Operations for biologics manufacturing.
* Experience as a Project Manager with cross-functional team members Competent in analyzing complex situations and showing practical problem-solving capabilities
* Excellent communication skills and fluency in English, German is a plus
This is a unique opportunity to immediately join a renowned international company and assume a key leadership role as an integral part of the team for the next 18 months.
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