Cmc Project Manager - Geneve, Schweiz - Alentis Therapeutics AG

Alentis Therapeutics AG

Geprüftes Unternehmen

Geneve, Schweiz

vor 2 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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 ontime 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 preIND 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 highquality 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
Setup and maintain the internal CMC regulatory tracker in countries/regions of interest
Review postapproval 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
Handson 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 problemsolving attitude in a multicultural environment

Work location:
On site with 1 day home office, contract with Alentis Geneva Office

Work permit:
EC national or appropriate work permit