Analytical Project Manager
Location:
Basel, BS, CH
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 which are:
Job Responsibilities
1. 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.
2. Management of a product portfolio of approx. 2-4 projects (depending on the live cycle of the project)
3. Managing analytical projects with CMOs and CROs
4. Development, 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.
5. Representation of AD/QC in technical project team and Product team meetings
6. Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
7. Review, approval according to internal procedure, interpretation of analytical data including results from method development, release, retest, validation, stability, and transfer.
8. Write-up, review and approval according to internal procedure of analytical protocols and reports and establish specifications.
9. Assurance of adequate maintenance and operation of analytical equipment according to GMP.
10. Drafting and review and approval according to internal procedure of CoAs, Analytical results sheets,
specifications, SOPs, GUIs, TPLs and FRMs.
11. Organization of GMP-(re)qualification and validation of analytical equipment with external companies.
12. Independently designs and executes projects or experiments with hands on involvement.
13. Independently reviews scientific work in project related activities.
14. Independent evaluation and development of novel analytical techniques and instrumentation.
15. Establishment 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.
16. Participate in technology transfer between laboratories, both internal and external to the company.
Candidate's Requirements
17. College-, 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.
18. Good knowledge in GMP regulations and regulatory requirements to successfully develop Drug Substances and Drug Products from early phase to commercialization
19. Broad knowledge in analytical chemistry (HPLC-UV, HPLC-MS, GC-MS, NMR, Spectroscopy, wet chemistry,
Dissolution).
20. Sound knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing
21. Experience in the development and performance of analytical tests for a variety of drug substances and products like Oral Solid dosage forms, vaccines, parenterals
22. Experience in international and cross‑cultural environments.
23. Excellent written, verbal, and listening communication skills.
24. Excellent at problem solving and ability to measure and manage risk(s)
25. Effective negotiation and influencing capabilities.
26. Reliable, conscientious, and adaptable.
27. Ability to work independently and collaboratively in a matrixed environment.
28. Ability to travel at least 25%.
29. 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.
Idorsia 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.
Please 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.