About Idorsia Pharmaceuticals Ltd
Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.
In order to achieve this, we want to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,000 highly qualified specialists dedicated to realizing our ambitious targets.
We are looking for a Microbiological Operations Manager to join our team !
- Lead all microbiology quality control team activities.
- Act as the single point of contact for any microbiological questions within Idorsia.
- Build and recruit a team of highly skilled specialists with the right flexibility and competences.
- Implement and maintain the microbiological quality control laboratory based on the respective
- healthy authority regulations.
- Set microbiology quality control strategies and direction for Idorsia (i.e. for ADQC as well as other
- departments within Idorsia).
- Build environmental monitoring program, set appropriate levels, and define trending tools to control
- manufacturing processes.
- Develop, implement, and foster the company quality culture.
- Review and approve standard operation procedures, methods and specifications that impact
- product quality.
- Define and support acceptable specifications, levels or acceptance criteria, where the
- pharmacopeia does not provide guidance.
- Ensure that out-of-investigations or non-conformances are investigated, well documented and
- appropriate CAPAs are defined and implemented.
- Support regulatory inspections and client audits.
- Ensure a GMP-compliant technical transfer process.
- Maintain current knowledge of applicable regulations, guidelines, and standards.
- Experience in Microbiology Quality Control and strong knowledge of GMP functions
- Good knowledge of GMP-regulatory documents
- General knowledge of manufacturing processes and analytical methods - excellent knowledge of validation and qualification process would be an advantage (aseptic and non-sterile)
- Hands on experience with and satisfactory ability for aseptic skills
- Excellent interpersonal, communication, and collaboration skills
- Strength in delivering results on critical deadlines to support product development programs
- Good troubleshooting skills for analytical analyses
- Inspection and auditing hosting experience
- Sound scientific expertise in microbiology
- Regulatory knowledge of compendial Microbial Assays would be an asset
- Profound understanding of QC laboratory processes and knowledge in QC related applications
- Knowledge of Rapid Microbial Methodology and implementation strategy would be an asset
- Solution oriented quality mindset
- Fact-based decision maker with strong collaborative mindset
- Read, writes and speaks German and English
- Ability to work independently and to take initiative
- Life-long learning mindset and strong sense of accountability
- Ability to prioritize and manage work to critical project timelines
- Able to influence the industry or authorities to create future standards
What Idorsia offers
Exciting opportunities for development and professional growth within our dynamic organization
A collaborative and solution-oriented environment where you can make a difference
An innovative and open culture in a truly multicultural environment
A competitive salary and generous social benefits
Work Location: Allschwil (Basel Area)
Business Area: Global Pharmaceutical Development & QA - Analytical Development and Quality Control Microbiology Laboratory
Job Type: Permanent
Job ID: 3166
If you are interested, please click on apply now.
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.
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.