Associate Director, Technical Development

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.

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)).

• 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.