External Manufacturing Specialist

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 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:

• Degree in Pharmacy or Chemistry. Master or Postgraduate specialized in Pharmaceutical Industries or analytical techniques will be a plus.


• 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, capsules)


• Oral liquid forms


• Injectable products

• GMP Guidelines


• Change Control procedures and Quality support


• Good understanding of the Variation Guideline


• Availability to travel (Support to CMO’s for implementing, improving, applying changes, etc into manufacturing process)

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 40 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, one in the Middle East, one in Australia, and globally via partners in more than 50 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!

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com

If you want to join us, this is your opportunity!

WE COUNT ON YOU, YOU COUNT ON US

At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.

We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.

We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.