Cmc Project Manager

vor 2 Wochen

Geneve, Schweiz Alentis Therapeutics AG Vollzeit

**Job Profile**:
The CMC operations project manager is responsible for coordinating, planning, managing and administering the outsourced CMC activities for Alentis monoclonal antibody products. The position includes and the preparation of CMC regulatory dossiers. His function will report to the CMC Program Lead.

**Responsibilities**:
**Technical**:

- Project and timeline monitoring
- Attend regular meetings (TC) with external CMOs and lead the discussion as primary contact for Alentis in CDMO/CRO external CMC project team
- Oversee USP/ DSP development/ production activities and provide technical support and troubleshooting
- Oversee the development and qualification of analytical methods to ensure effective characterisation and release of clinical batches
- Design and oversee formulation development and stability studies for drug substance and drug product
- Collaborate with line manager to develop and implement specifications for drug substance and drug product
- Review and coordinate internal review process of technical documents (ie, master and executed batch records, change controls, deviations, etc.)
- Create trending tables to monitor the stability of each manufactured DS/DP batch over time
- Track actions and follow up on any discrepancies with contractors and/or line manager
- Collect relevant documents required for the generation of regulatory dossiers and batch release
- Participates in regular internal project meetings to discuss and plan projects
- Follow the invoices and confirm the corresponding work execution to the line manager
- Collaborate with clinical ops to ensure that drug supplies are available on-time for support of clinical studies and coordinate DP shipping with logistic departments
- Collaborate with QA to manage out of specifications, deviations, CAPA and investigations

**Regulatory**:

- Draft and compile pre-IND briefing book (Quality section), Module 3 and IMPD in accordance with guidelines
- Propose and discuss the CMC section drafting plan with line managers, program leads and external regulatory consultant
- Coordinate internal review process of documents before submission
- Provide status updates on project activities to the line manager
- Ensure timely delivery of high-quality CMC documents in line with company project plans
- In collaboration with line managers, draft the responses to health authority comments and questions related to CMC topics
- Evaluate proposed manufacturing and quality changes and liaise with line manager for the implementation in the CMC development plan
- Set-up and maintain the internal CMC regulatory tracker in countries/regions of interest
- Review post-approval changes (change controls) and assess the regulatory impact on affected registrations

**Qualifications & Experience**
- Master degree or PhD in Biology, Biotechnology, Pharmacy, Pharmaceutical Sciences
- 3+ years of industry experience in biopharmaceutical manufacturing management
- Hands-on experience (authoring and reviewing) in regulatory CMC for biopharmaceuticals would be a plus
- Excellent planning and organizing skills, able to manage multiple tasks simultaneously and set priorities
- Good knowledge of GMP, GLP, GCP, Regulatory processes
- Experience in managing CMOs and CROs on a global basis
- Fluent in English (spoken and written), any further languages are an asset
- Proficiency in MS Office package and data analysis in Excel
- Flexible, proactive, efficient and able to work independently with a problem-solving attitude 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

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