Within the framework of the Development of Drug Product Process, Synergy is looking for an Analytical Senior Scientist in analytical development with experience to execute the following tasks:
- To assure the scientific, technical and operational monitoring of the activities of development, qualification and validation of analytical methods carried out by an external commercial manufacturer (outsourced activities) or at the client sites to support process development.
- To assure the scientific, technical and operational monitoring of the validation of the analytical methods
- To assure the repatriation at the client facility of all the analytical knowledge generated within the framework of the project for the process development.
- To write supportive technical document, review and/or write validation protocols and report
- Operational activities (fully self-sufficient)
- Job responsibilities:
- Supervision of the analytical part of the pharmaceutical development project carried out by the commercial manufacturer.
- Participate to the optimization of the analytical solutions to reach fit-for-purpose best balance of quality/time and costs
- Supervision of the analytical method validation (internal or external exercise)
- Provision when needed of high-quality documentation of all technical work performed by the external partner, including writing and review of protocols, reports and methods.
- Manage the external partner in the conduct of the analytical part of the project in order to meet deadlines within given constraints in resources, time, costs etc.
- expert in the analytical domain to interact with the Scientist in charge of the project at the external laboratory
- Participate to scientific/technical/operational meeting/teleconference with the external partners
- Participate to all appropriate internal meeting in framework of the project
- Participate to the external partners performance management
- Is attentive that all activities carried out by the external partner comply with all appropriate regulations (GMP, HSE, ISO140001...) and SOPs
Specific professional/technical expertise and key skills required:
- PhD or Engineer or Master in Analytical Chemistry
- International experience is a plus
- Language skills:
- English: good in speaking, reading and writing - able to communicate with English-speaking partners
- French: mandatory / fluent
- Experience in drug product development, method development, validation and transfer of analytical methods in a Pharmaceutical Company: 5-10 years
- Experience in managing/leading analytical project in a Pharmaceutical Company: min 3-5 years
- Demonstrated capacity for developing/managing/leading projects with outsourced resources
- Experience in problem solving in the Chemical / Pharmaceutical industry
- Must be able to independently manage scientific tasks in order to meet deadlines within given constraints in resources,
- Team player demonstrated capacity to work in a matrix environment,
- Compliant/rigorous (understands the importance of following procedures in detail)
- Be able to activate all appropriate internal /external experts to solve issues
- Detailed understanding of regulatory and GMP quality constraints
- Demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
Key technical backgrounds: small-molecule chromatography (UHPLC/HPLC/GC) and detection techniques (UV/Vis, MS), dissolution, USP/EP pharmacopoeias, ICH guidelines
if you are interested please contact firstname.lastname@example.org
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