Process and Project Manager Pilot Plants & Systems (temporary, 2 years)

Process and Project Manager Pilot Plants & Systems (temporary, 2 years)

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

“Global Technical Development” (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, partnership, dedication, and mutual respect and contributes every single day, continuously improving what it does.

“Small Molecules Technical Development” (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), and analytical sciences, and collaborates closely with key partners in Research and Early Development (pRED / gRED), Small Molecule Manufacturing (PTC) and other departments in Global Technical Development (PTD). PTDC is responsible for late stage technical development of our small molecules (SM) pipeline and manufacture of DS and DP for clinical studies across our SM manufacturing network.

This position is part of the Drug Product Small Molecules Development organization, is reporting to the Section Head of Pilot Plants & Systems. As a Process and Project Manager you are responsible for supporting the manufacturing of innovative drug delivery systems of new chemical entities in all clinical phases. You are ensuring SHE and clinical Good Manufacturing Practice (cGMP) compliance of our Drug Product Pilot Plant and Technikum with regard to systems, equipment, infrastructure, warehousing and logistics. In addition, you build up capabilities and competencies to leverage new manufacturing technologies and IT solutions to assure state of the CMC development.

Responsibilities include:

• Work together with associates having the focus on infrastructure, premises and systems as well as with Quality Assurance (QA), Engineering and other departments (e.g. Procurement, Commercial Manufacturing and IT) to support infrastructure and equipment related activities
• Develop and maintain systems, infrastructure and equipment for the GMP and non-GMP plants taking into account cGMP and SHE requirements
• Manage deviations and changes and represent the department in internal and external GMP and Safety, Health & Environment (SHE) audits
• Authoring, review and approval of SOP’s relevant for the area of responsibility (GMP Pilot Plant and Technikum)
• Within a team planning and coordination of development and manufacturing activities in GMP and non-GMP areas in close collaboration with the formulation and process development teams
• Support the evaluation and implementation of new IT systems (e.g. SAP ERP and MES) in close collaboration with QA and IT-function and contribute to the portfolio of Small Molecules-Drug Product manufacturing technologies and innovation

Your Profile:

The successful candidate has first experience in GMP manufacturing and Manufacturing Execution System (MES, e.g. PMX and PharmaSuite) applied in an IMP environment.

In addition, you meet the following requirements:

• You hold a Bachelor’s or Master’s degree in pharmaceutical sciences or equivalent preferably with a background in Drug Product development or manufacturing of oral dosage forms or Quality Assurance
• Capability to strive for excellent results and implement innovative solutions with a high level of motivation and the ability to work collaboratively in a matrix organization as well as independently
• Experiences in lean manufacturing and continuous improvement (e.g. lean six sigma) are a plus
• Interest towards Manufacturing IT Systems and IT-Manufacturing interdependencies is a plus
• Demonstrate excellent interpersonal and influencing skills, with high level of proficiency in German and English

Wer wir sind

Bei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

Job-Fakten

• Standort Schweiz, Basel-Stadt, Basel Headquarter
• Funktion Research & Development
• Subfunktion Research
• Arbeitszeit Vollzeit
• Funktionsebene Entry Level
• Art der Anstellung Temporär (Befristet)
• Firma/ Division Roche Pharmaceuticals
• Posted since 2019/04/12
• Job-ID 201807-114980

Kontaktieren Sie uns

Jonathan Weinhardt

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