Senior Expert

**Summary**:
LI-Hybrid

We are seeking a highly skilled and motivated Senior Expert to develop and implement analytical strategies to support late-phase product development and regulatory submissions for accelerated Biologics portfolio projects.

In the role of Senior Expert - Process Analytical Sciences, you will play a key role in driving Extractable and Leachable activities within late-phase development of New Biological Entity and Biosimilar projects. Your primary responsibility is to guide and manage activities within cross-functional project teams.

**About the Role**:
**Key Responsibilities**:
Your responsibilities include but are not limited to:

- Lead and represent in cross-functional project teams, acting as a single point of contact (SPOC) for all extractable and leachable related topics.
- Plan, manage, and control project resources, schedules, budgets and outsourcing activities.
- Review and Approval of laboratory data, internal and external documents.
- Writing and providing scientific justification for risk assessments, study protocols, study reports in the field of extractables & leachables.
- Ensure compliance with internal process requirements and current regulations.
- Support mock PAI’s (Pre-Approval Inspections) and Audits as Subject Matter Expert (SME).
- Prepare Biologics License Application (BLA) Submission relevant reports, assist teams in regulatory dossiers preparation and in responding to health authority questions.
- Proactively lead and drive initiatives independently, taking ownership from concept to execution while ensuring successful outcomes.

**Essential Requirements**:

- Master or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent.
- Minimum 3-5 years of experience in the pharmaceutical industry, preferably in Extractables & Leachables and/or late phase development.
- Excellent and extensive analytical understanding, e.g. HS-GC/MS, GC/MS, HPLC/MS.
- 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 standards and guidelines for Extractables and Leachable’s, e.g USP
,
,
,
, ISO-10993-17, ISO-10993-18.
- Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker.
- Fluent in German (oral and writing) and English (oral and writing).

**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 € 65,605.54 a 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.

**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

**Adjustments for Applicants with Disabilities**

Division

Development

Business Unit

Innovative Medicines

Location

Austria

Site

Schaftenau

Company / Legal Entity

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Adjustments for Applicants with Disabilities**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.