PpbAbout Idorsia Pharmaceuticals Ltd /b Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in‑house development pipeline; and a specialized drug discovery engine focused on small‑molecule drugs that can change the treatment paradigm for many patients. /p pbAnalytical Project Manager /b to join our team! /p pThe Analytical Project Manager is responsible for the development of analytical methods of Idorsia’s Drug Substance (DS) and Drug Product (DP) and the establishment of the analytical methods for Quality Control testing. The Analytical Project Manager ensures that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines. The Analytical Project Manager working in AD/DC will have the following responsibilities and tasks which are: /p h3Job Responsibilities /h3 ul liResponsible for the state‑of‑the‑art development of analytical methods for new drug substances and drug products being selected for preclinical and clinical development. /li liManagement of a product portfolio of approx. 2–4 projects (depending on the live cycle of the project). /li liManaging analytical projects with CMOs and CROs. /li liDevelopment, optimization and implementation of analytical methods, e.g., for purity, stability, cleaning verification/validation, excipients, content and potentially genotoxic impurity determinations as well as write‑up of the documents for implementation. /li liRepresentation of AD/QC in technical project team and Product team meetings. /li liProper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies). /li liReview, approval according to internal procedure, interpretation of analytical data including results from method development, release, retest, validation, stability and transfer. /li liWrite‑up, review and approval according to internal procedure of analytical protocols and reports and establish specifications. /li liAssurance of adequate maintenance and operation of analytical equipment according to GMP. /li liDrafting and review and approval according to internal procedure of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs. /li liOrganization of GMP‑(re)qualification and validation of analytical equipment with external companies. /li liIndependently designs and executes projects or experiments with hands‑on involvement. /li liIndependently reviews scientific work in project‑related activities. /li liIndependent evaluation and development of novel analytical techniques and instrumentation. /li liEstablishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings. /li liParticipate in technology transfer between laboratories, both internal and external to the company. /li /ul h3Candidate's Requirements /h3 ul liCollege‑ or university‑degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering required with: 10+ years BS, 7+ years MS or 2+ years PhD experience in the pharmaceutical industry with demonstrated previous success in a project management function. /li liGood knowledge in GMP regulations and regulatory requirements to successfully develop Drug Substances and Drug Products from early phase to commercialization. /li liBroad knowledge in analytical chemistry (HPLC‑UV, HPLC‑MS, GC‑MS, NMR, spectroscopy, wet chemistry, dissolution). /li liSound knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing. /li liExperience in the development and performance of analytical tests for a variety of drug substances and products like oral solid‑dose forms, vaccines, parenterals. /li liExperience in international and cross‑cultural environments. /li liExcellent written, verbal, and listening communication skills. /li liExcellent at problem solving and ability to measure and manage risk(s). /li liEffective negotiation and influencing capabilities. /li liReliable, conscientious, and adaptable. /li liAbility to work independently and collaboratively in a matrixed environment. /li liAbility to travel at least 25%. /li /ul pbWork Location: /b Basel Area /p pbBusiness Area: /b Analytical Development and Quality Control /p pbJob Type: /b Permanent /p pbAt Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success. We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration. We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees. /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 would be informed in greater detail in due course. /p pIdorsia Pharmaceuticals Ltd (“Idorsia”) is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. /p pPlease note 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, 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 /p #J-18808-Ljbffr