Manager, Technical Integrator Drug Substance

Vor 2 Tagen

YverdonlesBains, Schweiz Incyte Corporation Vollzeit

During the tech transfer of a new biologic product to Incyte Bioplant, the Technical Integrator Manager Drug Substance will mainly be responsible for the management of local tech transfer activities (manufacturing and QC readiness) in line with global tech transfer strategy (managed in the US). She/He will also manage continuous improvement and other projects to implement in Manufacturing on the Bioplant.

This requires managing projects executed by interdisciplinary team of process engineers, production technicians, scientists across manufacturing, Manufacturing Technology, Process Sciences, QC, QA, procurement, etc.

**DUTIES AND RESPONSABILITIES**

During the tech transfer phase, you will mainly:

- Provide technical oversight of tech transfer activities
- Coordinate local tech transfer activities by running weekly meetings, tracking actions and chasing action owners
- Track and report progress of Tech Transfer
- Actively interface with and influence Global Tech Transfer and translate Tech Transfer strategies into local actions, deliverables, etc
- Author the relevant section of the Tech Transfer plan and report
- Ensure that decision making is performed at the appropriate level
- Create a maintain a list of deliverables (for example Mass Balance, BoM, Room layout, Batch Records, sampling plan)
- Create and maintain a project timeline
- Create and maintain project RACI matrix
- Author, review Tech Transfer Policies, Work Instructions, SOP, etc
- Review relevant BLA sections
- Manage other projects to be implemented at manufacturing scale
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines

**REQUIREMENTS**
- PhD (preferred) or MSc in relevant discipline, like pharmaceutical sciences, pharmacy, (bio)chemistry or other life sciences or engineering.
- A minimum of 5 years pharmaceutical industry experience, preferably in a biopharmaceutical drug substance development environment
- Experience with tech transfer of biotechnology bulk Drug Substance
- Experience in the field of biotechnology production of Bulk Drug Substance
- Project management experience (certification preferred)
- GMP experience
- Excellent Project Management skills
- Good MS-Office knowledge and SAP (advantageous)
- Ability to work in a fast paced - high regulated environment
- French and English (Fluent)
- Team work oriented mindset

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

We Respect Your Privacy

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

  • Qc Lab Coordinator

    vor 1 Monat

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Aperçu: **SUMMARY** 1 year temporary - The QC Lab Coordinator supports the activities of the Quality Control department with missions related to administrative tasks such as documentation management and reconciliation, lab reagents/consumables purchase, related goods receipt, sample/material shipment arrangement, invoices reconciliation, production samples...

  • Qc Lab Coordinator

    vor 1 Monat

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Overview: **SUMMARY** 1 year temporary - The QC Lab Coordinator supports the activities of the Quality Control department with missions related to administrative tasks such as documentation management and reconciliation, lab reagents/consumables purchase, related goods receipt, sample/material shipment arrangement, invoices reconciliation, production...

  • Technician Quality Control

    vor 7 Monaten

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Overview: Technician QC Job Summary (Primary function) The Technician QC performs QC analysis to support production and release of drug substance, participates to equipment setting up, orders the material and reagent needed for the Lab, authors the analytical procedures and also the general QC procedures, like standard management, equipment usage, and/or...

  • Technician Quality Control

    Vor 3 Tagen

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Technician QC Job Summary (Primary function) The Technician QC performs QC analysis to support production and release of drug substance, participates to equipment setting up, orders the material and reagent needed for the Lab, authors the analytical procedures and also the general QC procedures, like standard management, equipment usage, and/or...

  • Processing Api Manager

    Vor 5 Tagen

    Yverdon-les-Bains, Schweiz MediCrops Holding AG Vollzeit

    **(Equal Opportunity Employer)**: - — Yverdon-les-Bains**Purpose of the Job**: - The Process API Manager will be responsible for the daily care of processing cannabis plants (Herbal Substance, Cannabis Sativa L.) into Herbal Preparation API (Cannabis Herbal Preparation) in the Processing Area (GMP) from Pre-Processing Decarboxylation (GMP), SFC CO2...

  • Qc Technician Physico Chemistry

    vor 4 Monaten

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Overview: **Job Summary (Primary function)** The QC Technician Physico Chemistry performs QC analysis to support production and release of drug substance, stability testing. The QC Technician Physico Chemistry also actively participate to new product introduction and method transfer. He/she also authors the analytical procedures and the general QC...

  • Technician Qc

    vor 2 Wochen

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Job Summary (Primary function) During the construction and QC laboratory startup phase, the QC technician will participate to equipment setting up. This person will also participate to the documentation preparation linked to QC activities. For the first project phase, the QC technician will be in charge of the utilities and environmental monitoring...

  • QC Lab Coordinator

    vor 1 Woche

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    OverviewSUMMARY1 year temporary - The QC Lab Coordinator supports the activities of the Quality Control department with missions related to administrative tasks such as documentation management and reconciliation, lab reagents/consumables purchase, related goods receipt, sample/material shipment arrangement, invoices reconciliation, production samples...

  • Processing Api Manager

    Vor 5 Tagen

    Yverdon-les-Bains, Schweiz MediCrops Holding AG Vollzeit

    **Purpose of the Job**: - The Process API Manager will be responsible for the daily care of processing cannabis plants (Herbal Substance, Cannabis Sativa L.) into Herbal Preparation API (Cannabis Herbal Preparation) in the Processing Area (GMP) from Pre-Processing Decarboxylation (GMP), SFC CO2 Extraction Processing (GMP), Evaporation/Fraction Processing...

  • Cultivation Manager

    Vor 5 Tagen

    Yverdon-les-Bains, Schweiz MediCrops Holding AG Vollzeit

    **(Equal Opportunity Employer)**: - — Yverdon-les-Bains**Purpose of the Job**: - The Cultivation Manager will be responsible for the daily care of medical cannabis plants (Cannabis Sativa L.) in Cultivation Area (GACP/GMP) from Mother/Clones Plants to Harvesting and from Harvest to Primary Packaging for the next pre - processing step (GMP) and for...

  • Ass. Director/director, E2e Supply Chain and

    vor 7 Monaten

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Aperçu: SUMMARY The AD/Director will be in charge of the entire Bioplant E2E (End to End) Supply Chain and Logistics from material procurements to drug substance (DS) batch release management. He or she will have the entire visibility of the Bioplant activity and will be the site depositary to supply on time and in full any commercial and clinical DS...

  • Marketing Manager for An International Company

    vor 2 Wochen

    Yverdon-les-Bains, Schweiz Academic Work Vollzeit

    You have already run marketing campaigns? You want to work for an international company in full growth? You are fluent in English? This opportunity is for you! **À propos du rôle**: Our client, an international company specialized in high-tech industry, is looking for its future marketing manager to join its team. You will develop and manage the marketing...

  • Project Manager

    vor 7 Monaten

    Yverdon-les-Bains, Schweiz Symbios Orthopédie S.A. Vollzeit

    Yverdon-les-Bains Posté il y a 2 heures To support our Continuous Improvement team, we are currently looking for a Project Manager - Manufacturing Execution Systems (MES) **Key responsibilities**: Coordinate a multidisciplinary project team to support the design, development, documentation, validation and implementation of Manufacturing Execution Systems...

  • General Manager, France

    vor 7 Monaten

    Yverdon-les-Bains, Schweiz Symbios Orthopédie S.A. Vollzeit

    Yverdon-les-Bains Posté il y a 3 heures To prepare for the upcoming retirement of our France Leader, we a looking to hire a key position leading our France Sales organization: General Manager, France This role will be directly leading the France Sales organization, and will be based at our site in Chassieu, France (Lyon area). **Key...

  • Cultivation Manager(Equal Opportunity Employer)

    Vor 5 Tagen

    Yverdon-les-Bains, Schweiz MediCrops Holding AG Vollzeit

    **Purpose of the Job**: - The Cultivation Manager will be responsible for the daily care of medical cannabis plants (Cannabis Sativa L.) in Cultivation Area (GACP/GMP) from Mother/Clones Plants to Harvesting and from Harvest to Primary Packaging for the next pre - processing step (GMP) and for further Extraction Processing activities (GMP). Also,...

  • General Manager Switzerland

    vor 4 Monaten

    Yverdon-les-Bains, Schweiz Symbios Orthopédie S.A. Vollzeit

    Yverdon-les-Bains Posté il y a 14 heures To prepare for the upcoming move of our current GM Switzerland/Austria to the position of VP Sales EMEA, we are looking to hire a key position leading our Switzerland and Austria Sales team: Country General Manager, Switzerland & Austria Reporting to the VP Sales EMEA of Symbios, this role will be directly leading...

  • Senior Manager ERP Tech Ops IT

    vor 3 Monaten

    Yverdon-les-Bains, Schweiz Incyte Corporation Vollzeit

    Overview: Job Summary (Primary function) The Senior Manager ERP Tech Ops IT will report to the Associate Director ERP Tech Ops and will be responsible for SDLC and ITSM activities associated with the Incyte SAP Ecosystem (primarily SAP S/4HANA). The primary SAP areas of focus for this role will be SAP Production Planning and Execution (including Detailed...

  • Technicien Support Niveau 1

    vor 3 Wochen

    Yverdon-les-Bains, Schweiz IT Advanced Consulting Vollzeit

    **Informations sur le poste**: ID du Affaire - ZR_5977_JOB Domaine - Technicien / Administrateur / Ingénieur / Système / Réseau Type d’emploi - Full time État/Province - Waadt Ville - Yverdon-les-Bains Pays - Switzerland Code postal - 1400 Date ouverte - 18/12/2024 Secteur d’activité - Grocery **Description du poste**: **Role...

  • Technicien Support Niveau 1/2

    vor 3 Wochen

    Yverdon-les-Bains, Schweiz IT Advanced Consulting Vollzeit

    **Informations sur le poste**: ID du Affaire - ZR_5977_JOB Domaine - Technicien / Administrateur / Ingénieur / Système / Réseau Type d’emploi - Full time État/Province - Waadt Ville - Yverdon-les-Bains Pays - Switzerland Code postal - 1400 Date ouverte - 18/12/2024 Secteur d’activité - Grocery **Description du poste**: **Role...

  • Technical Project Manager Intern

    vor 1 Tag

    Plan-les-Ouates, Schweiz Richemont Vollzeit

    Richemont owns some of the world’s leading luxury goods Maisons, with particular strengths in jewellery, watches, fashion, and accessories. Each Maison represents a proud tradition of style, quality, and craftsmanship, and Richemont seeks to preserve the heritage and identity of each of its Maisons. At the same time, we are committed to innovation and...