Associate Director, Technical Project Leader Drug Substance

Idorsia Pharmaceuticals Ltd; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Idorsia Pharmaceuticals Ltd in Basel Area is seeking an Associate Director, Technical Project Leader Drug Substance to lead the technical development of several drug substances from early phase to commercial supply, overseeing development, analysis, and scale‑up activities.

You will collaborate with external partners, ensure GMP compliance, define CPPs/CMAs, manage risk mitigation, and drive cross‑functional alignment with Drug Product teams; a Master/PhD with ≥5 years in pharma is preferred.

Qualifikationen

• Chemist, Chemical engineer or equivalent with Master or PhD (preferred) with minimum 5 years of relevant experience in the pharmaceutical industry.
• Minimum of 2 years of leading of an interdisciplinary drug product team.
• Scientific expertise in Drug Substance development and / or Manufacturing.
• Experience in setting development and regulatory drug substances strategies for products in development.
• Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines.
• Profound knowledge in QbD, DOE and QRM.
• Ability to negotiate, plan, and coordinate technical development and manufacturing activities.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
• Excellent English required (oral and written).

Aufgaben

• Lead the technical development of drug substances from early to late phase development up to commercial supplies.
• Lead manufacturing and scale‑up activities toward API including supplies of building blocks and GMP intermediates.
• Lead technical transfer for drug substance processes and define CPPs and CMAs.
• Coordinate development activities for development, scale‑up, validation and manufacturing of a drug.
• Collaborate with external development partners focusing on cost efficiency, timelines and quality.
• Work with Drug Product teams to address physico-chemical requirements for the DS.
• Develop and execute risk mitigation plans for drug substance supplies.
• Ensure compliance with regulatory guidelines including new initiatives (e.g., nitrosamines risk assessment).
• If needed, assume responsibilities of API safety project leader.

Kenntnisse

Leadership

Project management

Interpersonal skills

English (excellent)

Ausbildung

Master or PhD (preferred)

Tools

GMP knowledge

Jobbeschreibung

Location: Basel, CH

Associate Director, Technical Project Leader Drug Substance

The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.

Headquartered in Switzerland – a biotech‑hub of Europe – Idorsia is a high‑potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.

We are looking for a Technical Project Leader – Drug Substance to join our Drug Substance and Sourcing Strategy team to lead the development of new chemical entities with a focus on Drug Substance matters. Idorsia is currently running development programs for numerous products at all clinical phases (I, II & III) as well as managing commercial assets.

Job Responsibilities

• The Technical Project Leader Drug Substance will lead the technical development of several drug substances, from early phase to late phase development activities up to commercial and/or product discontinuation. Main responsibilities are as follows:
• Lead and manage development, analysis, and production of drug substance for the assigned projects for clinical and / or market supplies
• Lead manufacturing and scale‑up activities toward API including supplies of building blocks, Regulatory starting materials or GMP intermediates
• Leads technical transfer for drug substance processes and the definition of CPPs and CMAs for drug substances
• Lead the technical drug substance development activities (in house or external): plan, organize and administer the different aspects of the technical activities required for development, scale‑up, validation and manufacturing of a drug from development up to commercial supplies
• Lead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality
• Works collaboratively with Drug Product Technical Project Leader(s) to address any physico-chemical requirements for the DS
• Develop and execute risk mitigation plans for drug substance supplies
• Ensure compliance with regulatory guidelines and adapting to and implementation of new regulatory initiatives (e.g. nitrosamines risk assessment) at Idorsia
• Upon project needs at the discretion of the Head of DSDM, assume whole or partial responsibilities and tasks of API safety project leader

Candidate Requirements

• Chemist, Chemical engineer or equivalent with Master or PhD (preferred) with minimum 5 years of relevant experience in the pharmaceutical industry
• Minimum of 2 years of leading of an interdisciplinary drug product team
• Scientific expertise in Drug Substance development and / or Manufacturing
• Experience in setting development and regulatory drug substances strategies for products in development
• Profound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines
• Profound knowledge in QbD, DOE and QRM
• Ability to negotiate, plan, and coordinate technical development and manufacturing activities
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics
• Excellent English required (oral and written)

Work Location: Basel Area

Business Area: Technical Operations - Drug Substance and Sourcing Strategy

Job Type: Permanent

Job Id: 4799

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.