Associate Director, Technical Project Leader Drug Substance

Job description

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's Requirement 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 Country : Switzerland Business Area: Technical Operations - Drug Substance and Sourcing Strategy Schedule: Fulltime 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. Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course. Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.