Manufacturing Specialist

hace 3 semanas

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

  • Quality Control Specialist

    hace 1 mes

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    Quality Control 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! ...

  • Quality Control Specialist

    hace 3 semanas

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    Quality Control 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! ...

  • QA Specialist

    hace 3 semanas

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    About the Neuraxpharm Group Neuraxpharm is the 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...

  • Quality Control Specialist

    hace 7 días

    Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    Quality Control Specialist – External Manufacturing ManagementNeuraxpharm is seeking individuals who are passionate about making a positive impact and enhancing the lives of patients within the CNS field. We are looking for proactive team players who are committed to achieving remarkable results.Joining our team means working not just for a company, but...

  • Planning Specialist

    hace 2 meses

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    WE ARE HIRING! Production Planner 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...

  • Planning Specialist

    hace 7 días

    Sant Joan Despí, Barcelona, España Neuraxpharm A tiempo completo

    WE ARE HIRING Production Planner 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 ...

  • Planning Specialist

    hace 3 semanas

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    WE ARE HIRING! Production Planner 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...

  • QP Buccolam QA

    hace 2 meses

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    About the Neuraxpharm Group Neuraxpharm is the 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...

  • Corporate Master Data Specialist

    hace 4 semanas

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    Master Data Governance & Management Specialist 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...

  • Corporate Master Data Specialist

    hace 3 semanas

    Sant Joan Despí, España Neuraxpharm A tiempo completo

    Master Data Governance & Management Specialist 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...

  • IT Specialist Trainee

    hace 3 semanas

    Sant Joan Despí, España Ecolab A tiempo completo

    JOB DESCRIPTION Additional Job Description IT Support Trainee Are you a brilliant mind with an interest in Information Technology? Would you like to challenge yourself in a dynamic international environment? Ecolab is looking for an IT Support Trainee who can efficiently support our IT team, contributing to the ongoing success of the company. This is a...

  • Biologics Drug Product Senior Scientist

    hace 2 semanas

    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:15 May 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: We are a growing team involved in many Biologics projects where everyone contributes to bring the best products to patients. We are looking for a Biologics Drug Product Senior Scientist to join us in our R&D centre in Barcelona. Our...

  • Digital Asset Management

    hace 3 semanas

    Sant Cugat del Vallès, España Omega CRM A tiempo completo

    Omega CRM Consulting is looking for a Digital Asset Management (DAM) Support Specialist   that would like to collaborate with one of the top global pharmaceutical companies.   Digital Asset Management (DAM) Support Specialist supports the Digital Asset Management platform (DAM), global platform for storing, managing, and sharing our creative content...

  • Biologics Drug Substance Senior Scientist

    hace 2 días

    Sant Feliu de Llobregat, España Almirall A tiempo completo

    **Date**:25 Jun 2024 **Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain **Company**:Almirall **Mission**: The Biologics Development department in Almirall is growing and we are looking for a Drug Substance Scientist/Manager that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center...

  • Product Safety Specialist Material Declaration

    hace 7 días

    Sant Cugat, Barcelona, España Roche A tiempo completo

    The Position for English version see below - Als Product Safety Specialist (m/w/d) bist Du Mitglied unserer globalen Einheit "Diagnostics Product Sustainability & Compliance". Die Abteilung Compliance Operations ist verantwortlich für die Daten- und Prozesse innerhalb von Diagnostics Quality & Regulatory, die eine chemikalien- und umweltrechtlich...

  • Product Safety Specialist Material Declaration

    hace 7 días

    Sant Cugat, Barcelona, España Roche A tiempo completo

    The Positionfor English version see below -Als Product Safety Specialist (m / w / d) bist Du Mitglied unserer globalen Einheit Diagnostics Product Sustainability & Compliance .Die Abteilung Compliance Operations ist verantwortlich für die Daten- und Prozesse innerhalb von Diagnostics Quality & Regulatory, die eine chemikalien- und umweltrechtlich konforme...

  • Biologics Drug Product Senior Scientist

    hace 1 mes

    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission  We are a growing team involved in many Biologics projects where everyone contributes to bring the best products to patients. We are looking for a Biologics Drug Product Senior Scientist to join us in our R&D centre in Barcelona. Our biologics pipeline is growing, and we need your competences to secure our end goals are met. As our Drug Product...

  • Biologics Drug Product Senior Scientist

    hace 3 semanas

    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission  We are a growing team involved in many Biologics projects where everyone contributes to bring the best products to patients. We are looking for a Biologics Drug Product Senior Scientist to join us in our R&D centre in Barcelona. Our biologics pipeline is growing, and we need your competences to secure our end goals are met. As our Drug Product...

  • Biologics Drug Substance Senior Scientist

    hace 16 horas

    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    MissionThe Biologics Development department in Almirall is growing and we are looking for a Drug Substance Scientist/Manager that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center in BarcelonaOur biologics pipeline is growing, and we need your competences to secure our end goals are meet.As...

  • Biologics Drug Substance Senior Scientist

    hace 20 horas

    SFEL - R&D SANT FELIU DE LLOBR, España Almirall A tiempo completo

    Mission The Biologics Development department in Almirall is growing and we are looking for a Drug Substance Scientist/Manager that is going to help us bring the best innovative biopharmaceuticals to patients and will join the team in our R&D center in Barcelona! Our biologics pipeline is growing, and we need your competences to secure our end goals are...