As a member of the growing BPRnD, you will be responsible for the ensuring and supporting a fast and efficient Tech Transfer from development area to clinical manufacturing to keep the company at the forefront of clinical manufacturing of biologics.
- ID: 19076
- Employment type: Temporary via nemensis ag, 100% (Maternity cover)
- Duration: 01.07.2023 - 29.03.2024
- Salary: CHF 47 - 57.- / h gross
Your responsibilities:
- Support coordination of efforts with colleagues across the local site and global MSD network in shaping and implementing a robust and efficient Tech Transfer process for GMP Batch and Continuous Manufacturing of Drug Substance
- Contribute/lead tiered meeting structure support coordinating activities locally and with international (US, Ireland) groups for implementation of new processes for Drug Substance manufacturing
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop
- Contribute/support in various teams as WAG manufacturing representative
- Technical review of process descriptions, related documents and Campaign summary reports
- Ambassador of the global Tech Transfer procedure SOP to ensure standard process descriptions used to simplify Tech Transfer internally. Continuously bring in ideas for improvement of the process descriptions to accelerate Tech Transfer
- Bring in ideas and work to harmonize and simplify TechTransfer in batch and continuous manufacturing, for easy flexibility in switching between the two paradigms
- Support the development of GMP Documentation such as: Risk Assessments, Investigations, Changes, Batch Records, Sampling Plans and SOPs/WI's
- Provide quality assurance and GMP compliance support within global and interdisciplinary teams
- Support to aggregate process related knowledge and centralize for knowledge management
Your profile:
- 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
- Experience as a Project Manager with cross-functional team members
- Understanding of Critical Process Parameters, Critical Quality Attributes and general principles of a Tech Transfer (New product introduction)
- Technical knowledge with Biologics drug substance operations and analytical testing or process development.
- Familiarity with Upstream and Downstream Unit Operations for biologics manufacturing
- Competent in analyzing complex situations and showing practical problem-solving capabilities
- Business Fluent in English (C1) and German (B1)
Contact:
Nicolas Gerster , 061 205 98 69, nicolas.gerster@nemensis.com
