Job Description Summary
Internal job title: Associate Director - Science & Technology
Location: Schaftenau, Austria
#LI-Hybrid
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/out‑sourcing 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 independently leading all analytical tasks of complex projects; leading GDPD/TRD/NTO x‑functional overarching initiatives; mentoring (senior) experts
Essential Requirements
Master or PhD in engineering or chemical/bio analytics or equivalent and significant 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)
You’ll receive
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 €78,383.90/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.
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
Coaching Skills
Data Science
Environment
Experiments Design
Health And Safety (Ehs)
Laboratory Equipment
Manufacturing Process
Materials Science
Process Simulation
Sop (Standard Operating Procedure)
Technical Writing
Waterfall Model
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