About Idorsia Pharmaceuticals Ltd 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.
We are looking for an Analytical Project Manager to join our team!
The 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.
Job Responsibilities
* Responsible for the state‑of‑the‑art development of analytical methods for new drug substances and drug products being selected for preclinical and clinical development.
* Management of a product portfolio of approx. 2‑4 projects (depending on the live cycle of the project)
* Managing analytical projects with CMOs and CROs
* Development, optimisation 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.
* Representation of AD/QC in technical project team and Product team meetings
* Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
* Review, approval according to internal procedure, interpretation of analytical data including results from method development, release, retest, validation, stability and transfer.
* Write‑up, review and approval according to internal procedure of analytical protocols and reports and establishment of specifications.
* Assurance of adequate maintenance and operation of analytical equipment according to GMP.
* Drafting and review and approval according to internal procedure of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
* Organisation of GMP‑(re)qualification and validation of analytical equipment with external companies.
* Independently designs and executes projects or experiments with hands‑on involvement.
* Independently reviews scientific work in project‑related activities.
* Independent evaluation and development of novel analytical techniques and instrumentation.
* Establishment of source documents for IND, IMPD and NDA/MA submissions as well as responding to agency questions and together with technical regulatory colleagues interacting with Health Authorities and reviewing CMC sections for IND/IMPD and NDA/MAA filings.
* Participate in technology transfer between laboratories, both internal and external to the company.
Candidate's Requirements
* College‑ or university‑degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering required with: 10+ years of actuarial experience, 7+ years Master’s experience or 2+ years PhD experience in the pharmaceutical industry with demonstrated previous success in a project management function.
* Good knowledge in GMP regulations and regulatory requirements to successfully develop Drug Substances and Drug Products from early phase to commercialization.
* Broad knowledge in analytical chemistry (HPLC‑UV, HPLC‑MS, GC‑MS, NMR, spectroscopy, wet chemistry, dissolution).
* Sound knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing.
* Experience in the development and performance of analytical tests for a variety of drug substances and products like oral solid dosage forms, vaccines, parenterals.
* Experience in international and cross‑cultural environments.
* Excellent written, verbal, and listening communication skills.
* Excellent at problem solving and ability to measure and manage risks.
* Effective negotiation and influencing capabilities.
* Reliable, conscientious and adaptable.
* Ability to work independently and collaboratively in a matrixed environment.
* Ability to travel at least 25 %.
* Languages: fluent in English.
Work Location: Basel Area
Country: Switzerland
Business Area: Analytical Development and Quality Control
Schedule: Fulltime
Job Type: Permanent
At 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.
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 would be informed in greater detail in due course.
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