Manufacturing Specialist

hace 5 meses

Sant Joan Despí, España Neuraxpharm A tiempo completo

WE ARE HIRING

Manufacturing Specialist – External Manufacturing Management

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 Manufacturing Specialist – EMM based in Sant Joan Despí, Barcelona

Your mission:

Evaluation and assessment of manufacturing process for Semi finished: for solids and liquid forms (including sterile products and 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 life cycle 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 EMM department in accordance with current quality regulations.

Provide technical support and to coordinate with Tech Transfer responsible of CMO’s (sending units & receiving unit), QC & QA specialist and regulatory specialist. 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 life cycle, to evaluate and to improve the manufacturing process, based on experience and quality issues (manufacturing troubleshooting). Manage any change into manufacturing process. Tech support to CMO’s and to build up a win-win relationship with Tech counterpart at CMO’s. As project manager, to run project meetings to monitor project milestones, track project execution and report on progress, for TT and for any change related to manufacturing process. Cross-departmental relationship build up and to take care of company stakeholders.

We would like you to have:

Bachelor’s degree in pharmacy or chemistry Experience minimum demonstrable of 1-2 years as technology transfer in External manufacturing dept of a pharmaceutical company. Extensive knowledge of specific manufacturing processes for pharmaceutical products. FDF’s:Oral solid forms (tablets, fct, capsule), Oral liquid forms, Injectable products, GMP Guidelines. Change Control procedures and Quality support.Good understanding of the Variation Guideline Intermediate level of English and Spanish. Specific Knowledge: Quality Systems: GMPs, GLPs, Pharmacopoeia, ICH regulations and Office tools (MS Office) and LIMS and SAP software. Key Capabilities: Analytical thinking, and team player mentality, with organizational and prioritization skills. Availability to travel: 30 % Immediate availability.

ABOUT US

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain

Be part of the team where you can count on us to deliver:

Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy. Attractive remuneration according to the experience and skills provided. An inspiring leadership team that drives performance. An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert & excellent team

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