Associate Director - Extractables & Leachables - Technical Development
PositionVollzeit · Festanstellung · Director · Andere
KonditionenVor Ort
VergütungCHF 126,000.00 - CHF 234,000.00
Anforderungen10+ J. Erfahrung · Doktortitel
Deine Übereinstimmung
01
Skills
02
Learning AgilityCommunicationProblem SolvingBiotechnologyStakeholder engagementData integrationTeam managementanalytical chemistryFinancial Acumenrisk assessmentsStrategic PlanningRegulatory Compliance in Medicine
Sprachen
Englisch
Vergütung
03
CHF 126,000.00 - CHF 234,000.00
Die Stelle
04
01Provide expert support to a team of 4+ associates, including laboratory scientists and E&L experts (i.e. methods or analytical experts in the field of E&L).
02Guide specialty team in alignment with business priorities and agreed strategies on technical, scientific and project management matters.
03Act as Subject Matter Expert (SME) for E&L and lead relevant initiatives within the broader Organization.
04Engage with stakeholders and partners (e.g. Drug Substance ( DS) and Drug Product (DP) development, Manufacturing Science and Technology (MS&T), toxicologists) and manage interfaces as appropriate to ease workflows and satisfy partners.
05Coordinate end-to-end project support on relevant E&L activities and ensure submission readiness for projects assigned to team.
06Ensure compliance with regulatory requirements applying principles described in relevant guidelines e.g. from Food & Drug Administration (FDA), International Conference on Harmonization (ICH), United States Pharmacopeia (USP), International Organization for Standardization ( ISO).
07Support integration of Data & Digital tools and Artificial Intelligence AI in E&L workflows and contribute or lead related initiatives.
Anforderungen
↳University degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences or other relevant science discipline.
↳Minimum 10 years of proven experience in the pharmaceutical industry.
↳Minimum 5 years in a leadership position with successful performance and track record of leading teams.
↳Advanced knowledge in Extractables & Leachables (incl. Analytics/Regulation) as well as biotechnological CMC development.
↳Strong Leadership Skills: Proven ability to lead and inspire a team of scientists in a dynamic environment, with a “make-it-happen” spirit.
↳Solid business acumen with the ability to align scientific and technical decisions to organizational strategy and priorities.
↳Excellent communication and interpersonal skills.
↳Strategic thinking, high learning agility, solution oriented mindset.
Vorteile
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