Senior Expert - Device Project Leader - Combination Product Portfolio (m/f/d)
Salary Range:
€66,918.00 - €117,800.00
Band
Level 4
Job Description Summary
Location: Schaftenau, Austria, or Basel, Switzerland,#LI-Hybrid
With the increasing diversity of Novartis' portfolio, the need for driving our device portfolio is also increasing. As such, we are searching for a Senior Expert – Device Project Leader for joining our team in Basel or Schaftenau in the Portfolio & Customer Center within Global Device and Packaging Development.
Job Description
In the role of Senior Expert – Device Project Leader, you will be a vital part of the Portfolio & Customer Center within the Global Device and Packaging Development (GDPD) team based in Basel /CH or Schaftenau/AT. Your primary responsibility is to guide and manage cross-functional project teams both within and outside of the GDPD. This includes representing GDPD in the CMC sub-teams, leading relevant discussions, gaining support, and securing approval for project strategy and changes with the primary focus on the Cell & Gene Therapy (C>) and Radioligand Therapy.(RLT) projects.
Job Description
Your responsibilities include but are not limited to:
Represent GDPD in CMC sub-teams, leading device-related discussions and securing endorsement for project strategy or changes.
Lead cross-functional project teams, acting as a single point of contact (SPOC) for all device and packaging related issues.
Plan, manage, and control project resources, schedules, and budgets.
Assess and negotiate internal & external resource needs on an ongoing basis. Establish and maintain a high-quality if necessary adequate documentation up to Design History File, in case of the product is a combination product for developments and LCM projects until transfer to manufacturing sites.
Ensure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements.
Contribute to the improvement of process and delivery technology approaches.
Evaluate suitable device technology to support different project phases.
Support internal and external audits on packaging and medical device related matters.
Assist teams in regulatory dossiers preparation, including documents for medical device/combination product registration and in responding to health authority queries.
Essential Requirements:
Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
Minimum 2-4 years of experience in the pharmaceutical industry, preferably with experience exposure to C> and RLT and to drug-device combination product technical development including technical operations.
Ability to work and lead a cross-functional team in a matrix environment
Proven knowledge and track record in project and program planning and execution
Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and current good manufacturing practices (cGMP).
Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker.
Fluent in English (oral and writing), German is beneficial
Rewards:
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 € 65,605.54 EUR/year (on a full-time basis). The actual salary will be significantly 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 and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and 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
Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model