Senior Expert Medical Device Analytical Representative (fmd)

Band

Level 4

Job Description Summary

#LI-Hybrid

Internal job title: Senior Expert - Science & Technology
Location: Basel Switzerland or Schaftenau Austria

With the increasing diversity of Novartis portfolio the need for drug-device combination product analytical data packages is also increasing. As such we are searching for a Senior Expert - Medical Device Analytical Representative with combination product development experience to lead the creation of strong analytical data-packages.

As a member of the global Chemistry Manufacturing Control (CMC) analytical sub team and device sub team for your project(s) you will be the main contact & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all levels (from component to drug product to final product).

Job Description

Key Responsibilities:
As a member of global CMC analytical subteam and device subteam for your project(s) you are the contact person & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all levels (from component to drug product to final product); plan resource & budget for your project(s)

Select testing laboratory inline with resource availability capability and in/outsourcing strategy e.g. GDPD QC CRO; lead outsourced analytical project activities at CROs and contribute to manage external partnership

Own drug-specific analytical methods (AMs) / parameter sheets (PSs) organise and align x-functional inputs (e.g. with Device/Pack Tech); define organise document AM/PS validation and transfer

Co-shape and co-author x-functional analytical CMC strategies and documents e.g. drug product and final product stability strategy protocols and reports method validation and transfer status summaries Analytical Specifications (AS); organize input to Justification of Specification JoS (from Device/PackTech and HFE)

Contribute to and review regulatory documents support product registrations incl. present at inspections with minimal support by Leader or assigned to moderately complex projects

Essential Requirements:
Master or PhD in engineering or chemical/bio analytics or equivalent and some working experience in pharmaceutical industry in combination product development

Proven knowledge in late phase parenteral analytical development; leadership experience in managing development projects ideally in a global matrix environment understanding and awareness of regulatory guidelines for combination product analytics experience with cGMP and relevant ISOs

Collaborative spirit self-driven attitude high level of learning agility

Proficiency in English (written and spoken)

Youll receive (for candidates in Austria)
In addition to a market-competitive base salary we offer an attractive incentive program a modern company pension scheme childcare facilities learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is 65605.54/year (on a full-time basis). In most cases the actual salary will be higher as we strive to maintain a competitive position in the market and consider your previous experience qualifications and individual competencies.
We are open for part-time and job-sharing models and support flexible and remote working where possible.

Commitment to Diversity & 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 (for candidates in Switzerland):

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.

Adjustments for Applicants with Disabilities (for candidates in Austria):

If because of a medical condition physical disability or a neurodiverse condition you require an adjustment during the recruitment process please reach out toand let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative Behindertenvertrauensperson (BVP) in the application process. If you would like to request this please let us know in advance as a note on your CV.

Skills Desired