Technical R&D - Analytical Project Lead (m/f/d)

Gi Life Sciences Basel
Basel Il y a 55 jours CDI Ingénierie & Technique
Les ingénieurs procédés pharmaceutiques/ingénieures procédés pharmaceutiques conçoivent et développent des technologies utilisées dans la recherche et la fabrication de… Lire la suite →
📈 Perspectives moyennes
Gestion de projet & timelines Connaissance réglementaire Swissmedic & FDA Process Analytical Technology (PAT) & OEE Optimisation de la production et réduction des coûts
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For a leading pharmaceutical company, we are looking for a qualified


Technical R&D - Analytical Project Lead (m/f/d)

 

General Information:

  • Location: Basel
  • Workload: 100%
  • Start: ASAP
  • Duration: 12 months (Extension possible)
  • Home Office: max. 1 day per week

 

Your Responsibilities:

  • Serve as the Analytical SME / Analytical Project Lead (APL) and drive the development of state-of-the-art analytical control packages for synthetic molecules, including direct materials, IPCs, intermediates, and crude APIs
  • Actively contribute to portfolio delivery by ensuring efficient and effective process development analytics, including the use of modern approaches such as modeling and simulation
  • Coach technicians and junior scientists on project-related tasks and serve as a central point of contact for analytical topics and project information
  • Supervise internal laboratory activities and/or external testing activities at CLOs/CDMOs
  • Collaborate cross-functionally with key stakeholders in Research, Early Development, Regulatory, and Quality to ensure smooth project execution and alignment
  • Author, review, and approve key technical documents and regulatory dossiers such as QIMPDs and NDAs in compliance with quality standards and data integrity requirements
  • Act as Chemistry Project Lead (CPL) for external testing activities at CDMOs/CLOs
  • Support team development through coaching and contribution to the hiring of new colleagues

Your Profile:

  • Master’s degree or Ph.D. in Chemistry, Pharmacy, or a related field
  • Minimum 5 years of professional experience in the analytical development of synthetic molecule drug substances
  • Strong expertise in liquid chromatography, especially HPLC and UHPLC, combined with hands-on experience in advanced detection methods such as UV, MS, fluorescence, and charged aerosol detection
  • Solid understanding of analytical chemistry, especially chromatographic methods such as HPLC and GC, as well as titration and physicochemical techniques
  • Proven ability to independently develop analytical control packages for intermediates and APIs
  • Strong collaboration, technical leadership, and project management skills with a structured and rigorous working style
  • Experience in supervising laboratory work and managing external partners such as CDMOs and CLOs
  • Strong digital acumen and familiarity with the statistical analysis of analytical data
  • Experience in authoring and reviewing regulatory documentation, especially dossiers such as NDA and QIMPD
  • Excellent command of English, both written and spoken, German skills are an advantage

Interested? Then apply today. We look forward to hearing from you!

 

Foire aux questions — ingénieur procédés pharmaceutiques/ingénieure procédés pharmaceutiques

Gestion de projet & timelines · Connaissance réglementaire Swissmedic & FDA · Process Analytical Technology (PAT) & OEE · Optimisation de la production et réduction des coûts · Sécurité, qualité & bonnes pratiques de fabrication (GMP)
Salaire moyen estimé : 85'000 CHF/an.
Une formation de niveau Bachelor ou Master en génie chimique, génie des procédés ou ingénierie pharmaceutique, complétée par une spécialisation en contrôle qualité ou sécurité des procédés. Diplômes ou équivalences reconnus : E, n, S, u, i, s, s, e, ,, u, n, C, F, C, e, n, g, é, n, i, e, c, h, i, m, i, q, u, e, o, u, u, n, B, a, c, h, e, l, o, r, e, n, g, é, n, i, e, d, e, s, p, r, o, c, é, d, é, s, e, s, t, g, é, n, é, r, a, l, e, m, e, n, t, r, e, c, o, n, n, u, c, o, m, m, e, é, q, u, i, v, a, l, e, n, t, à, u, n, e, f, o, r, m, a, t, i, o, n, t, e, c, h, n, i, q, u, e, d, e, n, i, v, e, a, u, 5, ., L, e, s, d, i, p, l, ô, m, e, s, é, t, r, a, n, g, e, r, s, d, o, i, v, e, n, t, ê, t, r, e, é, v, a, l, u, é, s, p, a, r, l, \, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , .
Les perspectives d'emploi pour ce métier sont jugées moyennes en Suisse.
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