WE ARE HIRING
External Manufacturing & Project Manager
Neuraxpharm
is looking for people who want to make a difference and improve patients' lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause
Neuraxpharm is looking for a
External Manufacturing & Project Manager
based in
Sant Joan Despí
Your mission:
Evaluation and assessment of manufacturing process for:
Semi finished: for solids and liquid forms (including sterile products).
Pharmaceutical finished products: for solids and liquid forms (including sterile FDF).
For the assigned molecules and FDF, to become the Expert with regards of the manufacturing process along the lifecycle management of these FDF, that includes the management of changes into the manufacturing process, manufacturing troubleshooting, addition of new sources of API and any change that could affect to the manufacturing process (CPP and KPP), related with externals CMO's.
Within the life cycle management, to define a manufacturing transfer strategy for the defined TT projects. For that, the main topics are:
Manufacturing process Transfer / Validation strategy: GAP analysis of the different manufacturing processes between different CMO's for same FDF, taking into consideration Dossier paragraph per registered country
Raw materials: GAP analysis for excipients between sending Unit and receiving unit & API evaluation (CQA's impact for the manufacturing process)
Packaging materials:
GAP analysis for packaging materials between sending Unit and receiving unit & evaluation of any improvement according ICH stability and QA data from sending unit
GMP Guidelines and country requirements
Change Control procedures
Project Management: timelines – costs – risk management – change management
Write or approve the technical documentation of the EM LIFECYCLE MANAGEMENT department in accordance with current quality regulations.
Provide technical support and to coordinate Tech Transfer responsible of CMO's (sending units & receiving unit), QC & QA specialist and regulatory specialists towards the execution of all activities of preparation, follow up and achievement of objectives, supervise all the activities and results of the work defined in the tech transfer program/project. To define actions to address any gap or difficulty faced during the activities. Project management.
Your major accountabilities:
Revision of Manufacturing process Validation Protocols & Reports of manufacturing process for FDF's from CMO's. Whenever required, to provide support for the Protocol & Report edition to CMO's.
GAP analysis of the different manufacturing processes between different CMO's for same FDF. Raw materials GAP analysis and primary packaging materials GAP analysis.
Evaluate and approve starting materials and primary packaging materials to be used for validation batches during the TT. Revision of TT Protocols & Reports as part of the corresponding TT strategy for FDF
Define validation strategy taking into consideration technical feasibility, batch size and potential for commercial use. Support to manufacturing sites to produce trials, scale up batches and validation batches (onsite support). To become an Expert in terms of manufacturing process for assigned FDF's.
Management and review of the documentation provided by Receiving unit CMO's in reference to the Manufacturing process (Master batch record & Process validation report). Collect the Master Batch records from Sending unit CMO's and to review and file into NxP QMS system.
Writing of technical reports and SOP's (Standards Operating Procedures). Continuous learning for being the most updated possible in manufacturing process & validation requirements described in guidelines, etc. To support in the building up of the business intelligence with regards to different market requirements (FDA, US, ANVISA, EUR).
Support to Regulatory Affairs team to answer the deficiency letters from agencies or to clients' queries in life cycle management projects to get the dossier approval.
Support to QA dept with regards to any quality topic from manufacturing process for the assigned projects.
Support to CMO Management department in sharing all critical tech details that could affect into CMO selection for a new project.
Within the project lifecycle, to evaluate and to improve the ma