Analytical Project Leader (m/f/d) (80-100%)

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Analytical Project Leader (m/f/d) (80-100%). We are looking for an Analytical Project Leader to support Analytical Research & Development which sits within the… 390288BR

Analytical Project Leader (m/f/d) (80-100%) Switzerland

About the role

Location: Basel, Switzerland Role Purpose: We are looking for an Analytical Project Leader to support Analytical Research & Development which sits within the Global Technical R&D department of Global Drug Development and plays a crucial role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production. We need an experienced APL with a strong background and hands on experience in parenteral development to join our team. Expertise in RLT or peptide analytics is an asset. Your main responsibilities:
  • Be a member of a global CMC subteam, responsible for leading the technical development of Drug Substance and Drug Products from early to late phase clinical development.
  • Lead analytical activities within a Technical CMC project team, e. g. defining control and specification setting strategies for Drug substances and Drug products of small molecule new modalities (e.g., Radioligand Therapies, xRNAs,)
  • Lead a global analytical subteam and prepare analytical project plans and be accountable to meet quality, timelines and budget for assigned projects.
  • Responsible to provide valuable input to the analytical CMC documents and support regulatory submissions.
  • Write or contribute to analytical source documents (e.g., Analytical methods, Specifications, Validation reports, Stability reports)
  • Collaborate with internal and external stakeholders of drug development and mentor analytical experts.
  • Lead outsourced analytical activities at CROs / CDMOs and contribute to manage the external partnership.

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Essential Requirements:
  • Desirable: PhD in analytical chemistry or equivalent and a minimum 5 years experience in the pharmaceutical industry in analytical development, preferable in development of sterile parenteral products. Experience in Peptide or RLT analytic is a plus.
  • Proven knowledge in Early or late phase parenteral development and filings
  • Proven leadership experience in managing development projects, ideally in a global matrix environment.
  • Excellent understanding and awareness of regulatory guidelines for analytical development.
  • Collaborative spirit, self-driven attitude, high level of learning agility are key attitudes
  • Strong quality focus and experience in a cGMP environment.
  • Broad scientific knowledge in chemistry, pharmaceutical or analytical sciences, ability to perform in a highly dynamic environment.
  • Fluent in English (oral and writing), German/ French a plus
Why Novartis? Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

Development

Business Unit

TECHNICAL R & D GDD

Work Location

Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No

Next Process

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Post Date : 01-02-2024