Senior Specialist, Manufacturing (temporary Position)
Celgene Corporation
Zofingen, Aargau CH
vor 55 Tg.

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.

Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge.

With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

1.Competences

Under direction of the Sr. Manager, Manufacturing this individual is responsible to manage assigned tasks in Supply Chain activities with several Contract Manufacturers on operational topics and database management system.

The incumbent leads special projects related to external API manufacturing activities and supports the Sr. Manager, Manufacturing with daily business in relation with several CMOs.

2.Skills / Knowledge Required

  • Bachelor in Chemistry, Chemical Engineering or Life Sciences (Master an asset)
  • Ideally 2 years experience in the pharmaceutical industry in a Technical Operations or Development function
  • Good understanding of GMP / GDP requirements and of Quality Management principles
  • Experience with ERP systems : Oracle, SAP and OBIEE preferred, or similar
  • Background in Project Management and first hands-on experience; ability to coordinate and lead cross-functional teams of internal and external stakeholders
  • Good understanding in planning processes over different time horizons and the links between planning and operational activities
  • Strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required
  • Analytical mindset and strong process orientation
  • Strong organizational and coordination skills, ability to keep high level overview
  • Able to partner effectively with internal and external stakeholders
  • Effective and competent communication skills
  • Fluent in both English and German (oral and written)
  • Strong identification with Celgene’s values
  • Experienced in common computer software (Windows, MS Office, etc.)
  • 3.Duties and Responsibilities

    3.1Support of Ext. Manufacturing activities for assigned third party vendors (CMOs) :

  • Acquires basic process knowledge of Celgene’s commercial APIs manufactured at CMOs
  • Leads communication with CMOs on operational level, and supports Sr. Manager, Manufacturing in operational business with assigned CMOs
  • Follows production operations at CMO, in collaboration with Sr. Manager, Manufacturing and the Celgene appointed QA responsible.
  • Creates and updates campaign preparation documents (e.g. kick-off meeting preparation),
  • Initiates and assesses Change Requests, implements assigned Actions and CAPAs
  • Receives requests from CMOs on operational topics,distributes them to appropriate internal SME functions, coordinates and leads the discussions with internal and external stakeholders
  • Tracks campaign objectives and lifecycle requirements (e.g. initiation of stability studies, etc.)
  • Leads special projects on behalf of Sr. Manager, Manufacturing pertaining to lifecycle activities, new regulatory requirements, etc.
  • e.g. analytical method transfers, implementation of new ICHQ3D requirements at CMO)

    3.2Manage Supply Chain activities :

  • Execute transactions in Oracle related to assigned CMOs, like placement of purchase orders, material reception and material consumption
  • Contributes to control of inventory accuracy in Oracle (e.g. material status)
  • Runs reports in OBIEE; performs UATs and improves OBIEE reports in collaboration with PTM team to support Celgene Chemicals requirements;
  • is OBIEE super-use and primary point of contact to PTM team

  • Coordinates retesting activities of commercial API inventory with CMOs and internal functions
  • Contributes to reporting of external API manufacturing and Supply Chain activities to Celgene International Management
  • Tracks Key Performance Indicators for assigned CMOs and Celgene Chemicals; requests the necessary data from CMOs and internal functions and compiles them
  • Continuously improves and refines the CMO score card system for KPI and OTIF reporting
  • 3.3Various Tasks

  • Liaises with Logistics department for bulk and sample shipments
  • Is deputy of Logistics department for bulk shipments to micronization sites
  • Supports the creation of SOPs related to external manufacturing activities
  • Implements and maintains documents in CelDox and routes them for approval
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