Analytical Project & Development Manager Pharma (m/f/d)
gloor & lang is THE Career Partner for Swiss Life Science Industry: Pharma - Biotech - MedTech is our core competence. We are scouting specialistes and managers for exciting opportunities either permanently or contractor based. You are highly specialized? We are too!
Our customer is an innovative pharmaceutical company located in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs. The Technical Operations department conducts the development and production of clinical trial material and commercial products. An increased focus on marketed products makes it necessary to reinforce the in-house analytical team to handle those demanding projects.
The Analytical Project and Development Manager serves as interface, liaison and point of contact for all quality control related analytical activites within his projects, performed at external partners under GMP.
In this role, you are responsible for the definition, oversight and technical guidance of all analytical development and related activities for one late phase or some early phase development project(s) mainly performed at CRO/CMO. You select and manage providers of analytical services, including analytical services embedded in CMOs and monitor these for all CMC analytical activities for small molecules from starting material to DS and DP. You design and oversee the development, validation and transfer of phase appropriate analytical methods for raw material, IPC, DS and DP testing and ensure the availability of all required documentation. You actively contribute to CMC and project teams, and ensure alignment of analytical activities with the project development plans and contribute to specification preparation in accord with current regulatory requirements. You will also draft and review CMC sections of regulatory submissions along with other functional groups. Participate in preparation of responses to regulatory agency questions.
- Degree (MSc, PhD) in chemistry or pharmacy with specialisation in analytics
- Min. 2-3 years of Pharma Industry experience: analytical development or QC for DP or DS
- Experiences in the writing of CMC and/or RA documents (eCTD, Module 3)
- Project management capabilities, able to influence and drive project success
- Critical analysis with eye on details and inconsistent data
As a project manager with the described tasks and skills you take appropriate actions for resolution, including excellent communication skills at different levels and independent decision making.
You are very structured in your working approach, adopt a solution-oriented approach and have a highly accurate vision of analytical data, both from a scientific and regulatory perspective. You have excellent English skills. The position is based in Basel.
Interested? We are looking forward to get in touch with you.
Tel.: +41 61 206 61-81
Fax: +41 61 206 61-91