Job Description
The Analytical Outsourcing Lead is an individual expert contributor capable of independently executing writing assignments concerning the end to end outsourcing process (involving analytical strategies and/or specific assays) thorough deep understanding of analytical R&D processes and procedures. He/she would be expected to manage the third-party process and related documents in collaboration with Analytical Product Leaders, ARD technical experts, TRD experts, commercial QC, QA, Regulatory Affairs, Procurement and Finance. The Outsourcing lead has the ability to plan and prioritize with minimal supervision and liaise with more junior and more senior members of the team.
Your Responsibilities:
1. Managing the process for outsourced testing for clinical at all production steps in collaboration with BE, US and IT Product Analytic Senior Managers.
2. Leading the implementation of analytical outsourcing with key stakeholders like procurement, finance, due diligence, Quality and Third Parties based on requests initiated by APL and/or Analytical Platforms.
3. Managing PO and task order creation link with budget and quotation.
4. Requesting and following-up testing activities with Third parties like COA, protocol review and quotation request.
5. Closely working with project manager and analytical expert for budget alignment.
6. Supporting the sample management and shipping to Third Parties.
7. Ensuring the consistency and quality level of all documents that are issued requiring minimal quality check and rework.
8. Ensuring the quality assurance for all written materials within scope (reports, quotation, master service agreement, etc) in line with internal or external procedures.
9. Demonstrating skills in effectively managing assignments (including multiple priorities and responsibilities) and assures assigned milestones are achieved within the established time frames.
10. Having the ability to work within a complex matrix structure (with Analytical Product Leader, Technical Development Leader, Platform heads, technical experts) and drive the process.
11. Having the ability to establish a network of communication and continuously build collaboration to facilitate smooth partnerships and interfaces between all groups involved in project delivery.
Qualifications
12. MS with 3+ years of experience OR BS with 6+ years of experience.
13. Degree in Chemistry/Biochemistry/Biology or µAdministrative field with 5 year experience in pharmaceutical environment.
14. Possesses knowledge of internal processes/procedures.
15. Possess general computer literacy.
16. Possess excellent command over English language (verbal and written).
17. Proficiency in written and spoken English.
18. Ability to integrate and work in a team.
19. Flexible, and easily adapt to new/unexpected situations.
Additional Information
20. A full-time (40hours/week) Monday – Friday job.
21. A Permanent contract with flexible working hours.
22. Work in a fast-growing international organization.
23. Meal Vouchers 8 Euro/Working Day.
24. Eco-Cheques +/- 250 Euro/Year.
25. DKV Hospitalization insurance.
26. Additional 12 ADV days.
27. A company well-being program targeting both mental and physical well-being.
28. A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment
29. Personal development through learning on the job and additional trainings.