Associate Director - Extractables & Leachables - Technical Development

Salary Range:

CHF126,000.00 - CHF234,000.00

Job Description Summary

WORK ARRANGEMENT: Onsite, #Onsite
LOCATION: Basel, Switzerland
RELOCATION SUPPORT: This role is based in Basel, Switzerland. Novartis is unable to offer relocation support: please only apply if accessible.
We are seeking a highly skilled and motivated Associate Director to support the local Extractables & Leachables (E&L) Specialty team, contribute to the development and be responsible for the implementation of E&L testing and assessment strategies in alignment with the global E&L community and wider organization within a multidisciplinary project team developing biological drugs.

Job Description

ROLE PURPOSE
As Associate Director in the Extractables & Leachables (E&L) Specialty CH within Process Analytical Sciences (PAS), you will be part of a small team of 4+ associates, including laboratory scientists, methods and analytical experts. You will be directly responsible for managing Extractables & Leachables activities primarily related to late phase assets, with focus on complex and innovative medicines (i.e. Antibody-oligonucleotide conjugates (AOCs), Cell & Gene Therapy (CGT)). This includes guiding and driving activities within specialty and cross-functional project teams, shaping risk assessment and analytical strategies, developing concepts in line with internal and external regulatory standards while driving Data & Digital initiatives within the specialty.

KEY RESPONSIBILITIES

• Provide expert support to a team of 4+ associates, including laboratory scientists and E&L experts (i.e. methods or analytical experts in the field of E&L).

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

• Act as Subject Matter Expert (SME) for E&L and lead relevant initiatives within the broader Organization.

• Engage with stakeholders and partners (e.g. Drug Substance (DS) and Drug Product (DP) development, Manufacturing Science and Technology (MS&T), toxicologists) and manage interfaces as appropriate to ease workflows and satisfy partners.

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

• Ensure compliance with regulatory requirements applying principles described in relevant guidelines e.g. from Food & Drug Administration (FDA), International Conference on Harmonization (ICH), United States Pharmacopeia (USP), International Organization for Standardization (ISO)

• Support integration of Data & Digital tools and Artificial Intelligence AI in E&L workflows and contribute or lead related initiatives.

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.

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. 

Accessibility and Accommodation 

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 to receive more detailed information about the essential functions of a position, please email [email protected] and share the nature of your request along with your contact information. Please include the job requisition number in your message. 

Why Novartis: 

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture 

Benefits and Rewards: 

Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB) 

 

Skills Desired

Budget Management, Data Science, Process Simulation, Waterfall Model