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Cmc Program Lead
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**Job Profile**:
The CMC Program Lead is responsible for contributing strategically to CMC development planning and executing the CMC strategy for Alentis monoclonal antibody products.
The position includes the management of CMC project manager, the oversight of the outsourced CMC activities (such as cell line development and banking, USP/DSP/formulation development, analytical method development and qualification, DS and DP manufacture and release), the coordination and the preparation of regulatory submissions for biological products. This position will report to the Head of CMC.
**Responsibilities**:
- Oversee the outsourced CMC development activities and ensure GMP compliance where relevant
- Ensure and enforce adequate qualification and continuous GMP compliance of CMOs involved in manufacturing of biopharmaceuticals for human use, including the appropriate documentation, approvals, and qualification records
- Ensure timely supply of toxicology and clinical material meeting internal and regulatory quality expectations
- Provide leadership and drive to ensure that projects are executed on-time and within budget
- In collaboration with CMC project manager, review and approve technical documents (USP/DSP/Formulation/Analytical development reports, master and executed batch records, change controls, deviations, etc.) and manage stability data tracking for shelf-life extension
- Oversee interaction of CMC project manager with clinical operations and QA to ensure issuance of clinical-batch relevant documentation
- Represent relevant CMC activity at the functional project team level
- Manage scheduling, agendas and minutes preparation of internal CMC team meetings
- Proactively identify, assess and mitigate quality, operational and organizational risks; escalate key risks and issues to the line manager
- Ensure efficient monitoring/implementation of actions and decisions
- Ensure appropriate documentation maintenance at all levels (quality system, scientific reporting, etc)
- Manage contracts and review/approve vendor invoices according to the work performed
- Liaise with line manager for budget adjustments
**Qualifications & Experience**
- Master’s degree or PhD in Biology, Biotechnology, Pharmacy, Pharmaceutical Sciences
- 5+ years of working experience related to clinical development of monoclonal antibodies and/or biopharmaceuticals
- 3+ years of relevant experience in CMC management of biological drugs
- Solid experience in GMP manufacturing and CMC regulatory requirements for biopharmaceuticals
- Experience in authoring and reviewing eCTD CMC documents for biologics
- Excellent planning and organizing skills, able to manage multiple tasks simultaneously and set priorities
- Excellent communication skills (verbal, written and technical)
- Fluent in English (spoken and written), any further languages are an asset
- Able to guide clinical manufacturing, regulatory, QA according to cGMP requirements
- Proficiency in MS Office package and data analysis in Excel
- Ability to maintain detailed documentation
- Ability to work independently and as a team player in a multi-cultural environment
**Work location**: On site with 1 day home office, contract with Alentis Geneva Office
**Work permit**:EC national or appropriate work permit
