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.
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, become the expert with regards to 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 the manufacturing process (CPP and KPP), related with externals CMO's.
Within the life cycle management, define a manufacturing transfer strategy for the defined TT projects. The main topics are:
Manufacturing process transfer / validation strategy: GAP analysis of the different manufacturing processes between different CMO's for the 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 to 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 life cycle management department in accordance with current quality regulations.
Provide technical support, coordinate tech transfer, QC & QA specialists, 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; 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, provide support for the protocol & report edition to CMO's.
GAP analysis of the different manufacturing processes between CMO's for the 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 manufacturing sites to produce trials, scale-up batches and validation batches (onsite support). 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 review and file into NxP QMS system.
Writing of technical reports and SOPs (standard operating procedures). Continuous learning to be as up-to-date as possible in manufacturing process & validation requirements described in guidelines, etc. Support building up business intelligence with regards to different market requirements (FDA, US, ANVISA, EUR).
Support regulatory affairs team to answer deficiency letters from agencies or to clients' queries in life cycle management projects to get the dossier approval.
Support QA dept with regards to any quality topic from manufacturing process for the assigned projects.
Support CMO management department in sharing all critical tech details that could affect CMO selection for a new project.
In the project lifecycle, evaluate and improve the manufacturing process, based on experience and quality issues (manufacturing troubleshooting). Manage any change into manufacturing process. Tech support to CMO's and build a win‐win relationship with tech counterpart at CMO's.
As project manager, run project meetings to monitor milestones, track execution and report progress for TT and for any change related to manufacturing process. Build cross‐departmental relationships and take care of company stakeholders.
Desired Qualifications
Degree in Pharmacy or Chemistry. Master or postgraduate specialized in pharmaceutical industries or analytical techniques is a plus.
Minimum 1–2 years demonstrable experience as technology transfer in external manufacturing department 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.
Knowledge of GMP guidelines, change control procedures, quality support, and variation guideline.
Availability to travel to support CMO's for implementing, improving, applying changes into manufacturing process.
Benefits
Individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
Attractive remuneration according to experience and skills.
An inspiring leadership team that drives performance.
An inclusive culture promoting diversity across the teams.
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.
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