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 motivated Temporary ADQC Manager to join our dynamic team !
Design, plan, organize, interpret and report results of scientific experiments for the preparation and timely delivery of drug substance (DS) or drug products (DP), processes and procedures. Lead and manage all project and local network activities as well as support/coach/mentor team members, participate in sub-teams and contribute to overall GPDQA strategies and goals. AD/QC Manager must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.
The Manager working in AD/QC will have the following responsibilities and tasks:
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late-stage projects (typically phase 3 and commercial).
- Proactively communicate key issues and other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
- Manages a team of direct reports or for matrix organization lead with indirect leadership
- Leads cross functional teams related to analytical topics
- Acts as a Subject Matter expert (SME) on different analytical areas
- Organization of laboratory activities. Follow the processes defined in Guidelines and SOP's.
- 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 these documents for implementation.
- Representation of AD/QC in technical project team and CMC team meetings
- Conduct of release, retest, stability studies, transfer and validation analyses.
- 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, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
- Write-up and review of analytical protocols and reports and establish specifications.
- Assurance of adequate maintenance and operation of analytical equipment according to GMP.
- Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
- Ensuring initial and continuing training of the personnel of AD/QC and adaptation according to business needs
- Ensuring cleanliness of laboratory and workspace.
- Independently designs and executes projects or experiments with hands on involvement.
- Independently reviews scientific work in project related activities.
- Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.
- Contact 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Independent evaluation and development of novel analytical techniques and instrumentation.
- Leverages workload of respective project members to assure timelines and budget are met.
- 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
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
- Set and accomplish product development timelines working closely with formulation scientist.
- Responsible for the management of the GMP laboratory and employees
- Responsible for the analytical expertise for defined Idorsia drug substances and/or drug products
- Summarizing, defending and communicating results and product quality issues to management
- Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input and evaluation of the analytical services from the suppliers.
- Evaluation of analytical service providers including supplier selection for dedicated work packages (e.g. DS monitoring)
- Participate in technology transfer between laboratories, both internal and external to the company.
- Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures.
- Give analytical expert input for Product Quality Reviews (PQR)
- College-, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 12+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry with demonstrated previous success in a managerial function.
- In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required.
- Personality and disposition to manage professionals effectively in a matrix system. High flexibility, superior communication, time-management and team-working skills.
- Diligent attention to details.
- Willingness to limited travel.
- Ability to work independently and to take initiative.
- Proficient in English.
- Strong skills in timeline development and management.
- Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams
- Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development.
- Experience in the development and performance of analytical tests for a variety of drug substances and products.
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
Work Location: Allschwil (Basel Area)
Business Area: Global Pharmaceutical Development & QA - Analytical Development and Quality Control Drug Substance
Job Type: Temporary for 1 year
Job ID: 3474
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.