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Analytical Development and Quality Control Manager, Basel-Stadt
Client: CTC
Location: Basel-Stadt
Job Category: Other
Job Reference: 7da857a9a85c
Job Views: 4
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
Main Responsibilities:
* Manages a team of up to 3 direct reports.
* 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).
* 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.
* Organization of GMP (re)qualification and validation of analytical equipment with external companies.
* Elaboration of qualification plans and review of qualification documents.
* 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 for 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 drug substances and/or drug products.
* Summarizing, defending and communicating results and product quality issues to management.
Qualifications and Experience:
* Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
* 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. Diligent attention to details. Willingness to limited travel. Mature stable person with a positive and dynamic demeanor.
* High flexibility, superior communication, time-management and team-working skills. Ability to work independently and to take initiative.
* Proficient in English. Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
* Ability to complete assignments, meeting quality- and time-oriented objectives.
* Strong skills in timeline development and management.
* Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams of people with multiple perspectives and talents, capable of functioning as individual contributor or team leader.
* 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.
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