Analytical Project Leader (mf/d)
Analytical Project Leader (mf/d)
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Job Description
Job Description Summary
Location: Basel SwitzerlandRole Purpose:
We are looking for an Analytical Project Leader to support Analytical Research & Development (ARD) in the area of Project management. ARD sits within the Technical R&D department of Novartis Development and plays an essential role in the characterization and analysis of Drug Substances and Drug Products from the time the compounds leave the discovery laboratories until they are transferred to Commercial Production. We are looking for a highly motivated and experienced Analytical Project Leader with experience in Oligonucleotide analytics.
Job Description
Your main responsibilities:
You will be a member of a global CMC subteam which is responsible for leading the technical development of Drug Substance and Drug Products from early to late phase clinical development.
You will manage 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. xRNAs)
In your role you will be leading an analytical subteam and preparing analytical project plans and be accountable to meet quality timelines and budget for assigned projects.
You are responsible to accurately forecast FTE and cost demand for your assigned projects.
You are responsible for the timely issuance of analytical source documents (e.g. Specifications Validation reports Stability reports etc.)
You provide scientific inputs to the analytical CMC documents and support regulatory submissions.
You collaborate with internal and external stakeholders of drug development and coaching of analytical experts.
You lead outsourced analytical activities at CROs / CDMOs and contribute to manage the external partnership.
Educational background:
Desirable: PhD in analytical chemistry or equivalent and a minimum of 5 years experience in the pharmaceutical industry in analytical development as project leader preferable in development for sterile parenteral products. Experience in Oligonucleotides 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.
High level and intrinsic motivation to work with new development compounds where it is sometimes necessary to go the extra mile is a key element to our success.
Broad scientific knowledge in chemistry pharmaceutical or analytical sciences ability to perform in a highly dynamic environment.
Good scientific/technical writing skills.
Good understating on how to use novel digital tools to become more productive in a global project management environment.
Proven leadership in guiding and coaching colleagues
Excellent communication and role model skills
Fluent in English (oral and writing) German/ French a plus
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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Skills Desired
Required Experience:
Senior IC
Employment Type
Full-Time
