Associate Director, Technical Project Leader Drug Product

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ppb Associate Director, Technical Project Leader Drug Product /b /p /p Location: p Basel, CH /p pThe purpose of Idorsia is to discover, develop, and commercialize innovative medicines to help more patients.br/ br/ 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. /p pWe are looking for a bTechnical Project Leader – Drug Product /b to join our Drug Productand CMC strategy team to lead the drug product development.

Idorsia is currently running development programs for numerous oral products at all clinical phases (I, II III) as well as managing commercial assets. /p pbJob Responsibilities /b /p pThe Technical Project Leader Drug Product will lead the technical development of several oral solid dosage forms, from early phase to late phase development activities, including formulation development and production scale up with external partners.br/Main responsibilities are as follows: /p liLead and manage development, analysis and production of solid dosage forms, including clinical and market forms /li liLead the technical drug product 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 /li liLead the collaboration with external development partners with special emphasis on cost efficiency, timelines and scientific quality /li liSupport the development, communication and execution of the overall CMC strategy /li liAct as Subject Matter Expert for Drug product manufacturing activities, focusing on technologies required for the selected development programs. /li liEnsure sufficient and timely supplies for development projects based on input from the CMC, Project and/or Life Cycle management and Global Supply Chain functions /li liEnsure compliance with regulatory guidelines /li pbCandidate’s Requirements /b /p liPharmacist or Equivalent with PhD Minimum of 10 years job relevant working experience in the pharmaceutical industry /li liMinimum of 5 years of leading of an interdisciplinary drug product team /li liScientific expertise in small molecule formulation development /li liScientific expertise in oral solid dosage forms (conventional dosage forms), experience in Lipid Based Formulations and/or Amorphous Solid Dispersions is a plus /li liProfound knowledge of GMP, quality control and pharmaceutical development and/or production processes, based on current guidelines /li liProfound knowledge in QbD, DOE and QRM /li liAbility to negotiate, plan, and coordinate technical development and manufacturing activities /li liExcellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics /li liExcellent English required (oral and written) /li pbWork Location /b: Basel Area /p pbCountry /b: Switzerland /p pbBusiness Area /b: Technical Operations - Product Development and CMC Strategy /p pbSchedule: /b Fulltime /p pbJob Type /b: Permanent /p pbJob Id : /b4798 /p pbAt Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success.

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. /b /p pPlease 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. /p pIdorsia 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. /p