For our client, one of the leading pharmaceutical companys, we are looking for an experienced:
Analytical Project Leader (Scientist / Senior Scientist)
The position is in the Analytical Development Synthetic Molecules team within Pharma Technical Development.
The Analytical Development team is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of our work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply.
As Scientist in Analytical Development, you have a strong quality mind-set and excellent attention to detail. You routinely apply GMP requirements where necessary, and understand how to exert them in different clinical phases. You have solid IT/Digital skills to actively contribute to our digital transformation. You are open-minded, goal-oriented, and able to work in a fast developing environment. As a matter of course, you take challenges as opportunities and you are able to respectfully collaborate with team members, customers and stakeholders.
This role is to backfill someone leaving. The perfect candidate has minimum 3 years of experience in analytical development. Ideally, this person has pharma experience (academic experience is acceptable too as long as it was within relevant field). We are looking for minimum Master or PhD (Post Doc is acceptable too if obtained not long ago) in specific fields mentioned in the must-haves.
The candidate will be supervising technical work and lab technicians. Please note there is no direct management involved, it is only supervision. We would like someone with previous similar experience.
Tasks & Responsibilities:
- Cover all analytical aspects during the project development lifecycle (drug substance and/or drug product analytics of synthetic molecules)
- Deliver packages that provide a solid control strategy for reliable commercial manufacturing of each product
- Work in close collaboration with peers, lab technicians and cross-functional partners from e.g. process development, formulation, material sciences, manufacturing, regulatory affairs, and quality assurance
- Actively contribute to regulatory submissions such as IND and NDA by authoring relevant sections and provide scientific support to address any questions from the health authorities
- You will be part of larger Technical Development Teams in which you regularly report out your progress and in which you additionally collaborate with stakeholders from different disciplines, varying with the clinical phase of the project
- Contribute to or drive activities to implement innovative approaches and technologies in cross- functional teams
- Master or PhD in chemistry, pharmacy, biotechnology or biochemistry
- Min 3 y of experience in pharma (pharma preferred, university acceptable)
- Experience with analytical development, synthetic molecules technical development (small molecule)
- Experience with Health Authorities
- Experience supervising technical work and lab technicians
- Fluent English speaker (German is an advantage only)
Nice to haves:
- Experience with vendor management (CMO/CRO)
- Experience in analytical development with Oligonucleotides, Peptides, biologically derived molecules and/or broad and advanced formulation principles
- Start date: ASAP
- Latest possible start date: Early April (Max 1 month notice period)
- End date: 6 months duration
- Extension: possible
- Workplace: Basel
- Workload: 100%
- Remote/Home Office: around 50% onsite needed, Covid certificate required.
- Travel: No
- Team: Around 15 people
Please apply online. For further information about the position, please contact your Kelly recruiter, Judith Atgé Martin (+41 61 270 80 16).