Analytical Project Leader Scientist
vor 2 Wochen
Analytical Project Leader Scientist (m/f/d) - pharmaceutical / analytical development / PCR / GMP / IND (Investigational New Drug) and NDA (New Drug Application) submissions/ English/ German
Project:
For our customer, a big pharmaceutical company in Basel, we are looking for an Analytical Project Leader Scientist (m/f/d).
Background:
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10,000 employees worldwide.
Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops creative technical solutions to bridge early-stage, late-stage, and commercial product needs. The mandate of the group is to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
Synthetic Molecules Technical Development (PTDC) brings a broad range of experience across drug substance (DS), drug product (DP), analytical sciences, and Manufacturing Science & Technology (MS&T), and collaborates closely with key partners in the departments Research and Early Development (pRED / gRED), Small and Large Molecules (PTC, PTB), PTD, and MS&T across our manufacturing network.
This position on offer is located in Analytical Development Synthetic Molecules within Pharma Technical Development. Analytical Development 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 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.
The perfect candidate:
Has a Master Degree or Ph.D. in chemistry, pharmacy, biotechnology, or biochemistry and at least 3 years of professional experience in the pharmaceutical industry. Additional experience in analytical development with Oligonucleotides, Peptides, biologically derived molecules, and their advanced formulations is a plus, as well as knowledge in analytical methodologies such as PCR (Polymerase Chain Reaction) sequencing.
Tasks & Responsibilities:
- Cover all analytical aspects during the project development lifecycle
- Work in close collaboration with peers, lab technicians, and cross-functional partners from e.g. process development, material sciences, manufacturing, regulatory affairs, and quality assurance
- Plan and document your experiments/results independently, and prepare for regulatory submissions such as IND (Investigational New Drug) and NDA (New Drug Application)
- Be part of larger Technical Development Teams in which you regularly report out your progress
- Collaborate with stakeholders from different disciplines, varying with the clinical phase of the project
- Network closely with external partners such as CMOs and CROs (Contract Manufacturing/Research Organizations)
Must Haves:
- Master or Ph.D. in chemistry, pharmacy, biotechnology, or biochemistry
- Minimum 3 years of professional experience in the pharmaceutical industry
- Experience in analytical development with Oligonucleotides, Peptides, biologically derived molecules, and their advanced formulations is a plus
- Knowledge in analytical methodologies such as PCR (Polymerase Chain Reaction) sequencing is a plus
- Strong quality mind-set and excellent attention to detail
- Experience in applying GMP requirements where necessary, understanding how to exert them in different clinical phases
- Ideally experience of working in a paperless environment with strong IT skills to support digital transformation initiatives
- Open-minded, goal-oriented, and able to work in a fast-developing environment
- Takes challenges as opportunities and is able to respectfully collaborate with team members, customers, and stakeholders, even in stressful situations
- Fluent in English; German is a plus
Reference Nr.: 923941SDA
Role: Analytical Project Leader Scientist (m/f/d)
Industrie: Pharma
Workplace: Basel (max. 20% home office)
Pensum: 100 %
Start: ASAP (latest start date 01.04.2025)
Duration: until 2028
Deadline: 22.01.2025
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.
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