Senior Manager - Extractables & Leachables (m/f/d)

Job Description Summary

We are seeking a highly skilled and motivated Senior Manager at the Associate Director level to lead the local E&L Specialty team in Austria (Schaftenau), contribute to the development and be responsibe for the implementation of E&L testing and assessment strategies in alignment with the global E&L community and wide organization within a multidisciplinary project team developing biological drugs.

As Senior Manager of the Extractables & Leachables (E&L) Specialty AT within Process Analytical Sciences (PAS), you will lead a team of 9+ associates, including laboratory scientists, methods and analytical experts. You will be directly responsible for managing Extractables & Leachables activities primarily related to late phase NBE assets and Biosimilars. This includes guiding and driving activities within cross-functional project teams, shaping risk assessment and analytical strategies, and ensuring compliance with internal and external regulatory standards.

 

Job Description

Key responsibilities:

• Lead the Extractables & Leachables (E&L) Specialty in Austria (Schaftenau)

• Manage as Operational Manager a team of 9+ associates, including laboratory scientists and E&L experts (i.e. methods or analytical experts in the field of E&L).

• Provide accurate capacity and demand planning, plan resources for assigned projects.

• Support own team on technical, scientific and project management matters in alignment with business priorities and agreed strategies.

• Act as  SME for E&L, lead relevant initiatives within the broader Organization and manage interfaces as appropriate to ease workflows

• Coordinate end-to-end project support on relevant E&L activities and ensure submission readiness for projects assigned to own team.

• Ensure compliance with regulatory requirements applying principles described in relevant guidelines e.g. from FDA, ICH, USP, ISO

• Ensure alignment with the global E&L Specialty (Switzerland/Slovenia) on relevant workflows, processes, initiatives and strategies with focus on analytical and process excellence

• Anticipate future (regulatory, technical) trends and align on strategies to proactively support the organization.

Essential Requirements:

• University degree (preferably PhD) in Pharmacy, Biotechnology, Life Sciences or other relevant science discipline.

• Minimum 10 years of proven experience in the pharmaceutical industry.

• Minimum 5 years in a leadership position with successful performance and track record of leading teams.

• Advanced knowledge in Extractables & Leachables (incl. Analytics/Regulation) as well as biotechnological CMC development.

• Strong Leadership Skills: Proven ability to lead and inspire a team of scientists in a dynamic environment, with a “make-it-happen” spirit.

• Solid business acumen with the ability to align scientific and technical decisions to organizational strategy and priorities.

• Excellent communication and interpersonal skills.

• Strategic thinking, high learning agility, solution oriented mindset.

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-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 € 78,383.90 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

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. Th