Analytical Project Leader (m/f/d) at Novartis

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

07 Jun, 26

Salary

0.0

Posted On

09 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Analytical Development, Oligonucleotide Analytics, Drug Substance, Drug Products, Control Strategy, Specification Setting, CMC, Regulatory Submissions, CRO Management, CDMO Management, Analytical Chemistry, Parenteral Development, Leadership, Communication

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Location: Basel, Switzerland #onsite Role Purpose: We are searching 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 Main Accountabilities: 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 Ideal 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 filing Proven leadership experience in managing development projects, ideally in a global matrix environment. Excellent understanding and awareness of regulatory guidelines for analytical development. 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. Excellent communication and role model skills Good understating on how to use novel digital tools to become more productive in a global project management environment. Fluent in English (oral and writing), German is 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 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. Skills Desired Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The Analytical Project Leader will manage analytical activities within a Technical CMC project team, defining control and specification setting strategies for Drug Substances and Drug Products, particularly for small molecule new modalities like xRNAs. Responsibilities include leading an analytical subteam, preparing project plans, meeting quality/timeline/budget goals, forecasting FTE/cost demand, and ensuring timely issuance of analytical source documents.