Associate Director, Technical Project Leader Drug Substance Job Details | Idorsia

Das ist der Job

Lead technical transfer for drug substance processes and define CPPs and CMAs for drug substances.

Darum lohnt es sich

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. Minimum of 2 years of leading an interdisciplinary drug product team.

Associate Director, Technical Project Leader Drug Substance Location: Basel, CH The purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.

Headquartered in Switzerland, 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.

Idorsia is currently running development programs for numerous products at all clinical phases (I, II & III) as well as managing commercial assets. Job Responsibilities Lead the technical development of several drug substances from early to late phase development activities up to commercial and/or product discontinuation.

Lead and manage development, analysis, and production of drug substance for 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.

Lead technical drug substance development activities (in‑house or external): plan, organize and administer the different aspects required for development, scale‑up, validation and manufacturing from development up to commercial supplies.

Lead collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality. Work 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 adapt to and implement new regulatory initiatives (e.g., nitrosamines risk assessment) at Idorsia. Assume whole or partial responsibilities and tasks of API safety project leader at the discretion of the Head of DSDM, when project needs arise.

Candidate’s Qualifications Chemist, chemical engineer or equivalent with a Master or PhD (preferred) and minimum 5 years of relevant experience in the pharmaceutical industry. Scientific expertise in drug substance development and/or manufacturing.

Experience in setting development and regulatory drug substance 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 written and oral English required.

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. #J-18808-Ljbffr