Sample Manager Large Molecules (f/m/d)

Sample Manager Large Molecules (f/m/d) – laboratory/logistic/LIMS/ Veeva/ German

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Sample Manager Large Molecules

Background:
The Lab Support and Compliance section belongs to the „Operations Support & Compliance“ (OSC) area within the „Synthetic Molecules Technical Development“ (PTDC) at the Basel Site. The area is responsible for late-stage technical development of our Synthetic Molecules pipeline of Drug Substances (DS) and Drug Products (DP) for clinical trials.
The section provides key support activities for internal partners such as PTDE, responsible for the development of large molecule products, e.g., parenterals. In this context, the section is responsible for the smooth sample coordination between the logistics area and the various partners (CSC, production, various analytical laboratories, stability management, etc.).

The perfect candidate: has an educational background in laboratory work and 3 years‘ experience in working in the pharmaceutical industry, within a GMP environment as well as with SOPs. Additionally, the candidate is skilled in working with computers, especially with databases and GMP systems. Lastly, the candidate has very good German skills and good English skills. No PHD or MAster degree!

The perfect candidate:
In this role, the Local Deployment PMO is a member of the PTS Deployment Team and will enable successful business transformation by ensuring that local Project Management processes/practices are in place to meet the project deliverables, outcomes and schedule.
The local PMO will work in alignment with the Wave ASPIRE Project Office to establish the project plan framework and to understand core dependencies/critical path and dependencies on QA/Compliance and OCM The Local PMO will support the local Deployment Lead and E2E streams in their activities and ensure clear x-site communications, updates and reporting. Position will report to Local Deployment Lead and dotted line reporting to Wave Deployment PMO.

Tasks & Responsibilities:

• ensure on-time and compliant sample flow between manufacturers (incl. CMO) and Sample Office (PTDC-T) / main laboratory
  * Sample reception and control, incl. Check of the temperature logger and related GMP Documentation
  * Sample preparation (sorting, labeling)
  * Sample distribution to the internal partners, shipping to the external partners
  * Support the storage of stability samples
  * Login samples (polled bulk) and document the chain of custody within the LIMS System
  * Review and ensure the GMP documentation according to ALCOA principles (data integrity), Incl. planned and unplanned events (UPE and PE).
  * Collaboration/creation of task-related documents (e.g. SOPs)
  * Proposal/implementation of process improvements and harmonization
  * Support the other flex team members of the section
  * Support for inspections and audits ( incl. preparation)
  * Support/collaboration in task-related and relevant projects (continuous improvement, IT and CSV etc)
  * Critical assessment of your own work results to improve continuously

  Must Haves:

• Vocational training in laboratory, logistic, production or similar with relevant professional experience
  * At least 2 years of professional experience in the Pharmaceutical Industry, within a GMP environment and with SOPs
  * Good computer skills and familiarity with databases, and GMP systems (knowledge of SingleLIMS, Phoenix and Veeva is an advantage)
  * Very good knowledge of spoken and written German and good knowledge of English
  * Very high teamwork and excellent communication skills
  * Very high customer orientation, building and taking care of good relationships with internal and external partners
  * Very high flexibility and organizational talent, high commitment,
  * solution-oriented, able to work independently
  * High reliability, quality and safety awareness
  * Passion for continuous improvement activities

Reference Nr.: la
Role: Sample Manager Large Molecules
Industry: Pharma
Workplace: Basel
Pensum: 60-100%
Start: 01.07.2023
Duration: 12++

Deadline: 14.06.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.