Manager (Analytical Development and Quality Control)
- Interim/Contract
- Technical Operations
This vacancy has now expired. Please see similar roles below...
Hobson Prior are looking for a Manager (Analytical Development and Quality Control)
to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. You will be accountable to manage a team of up to 3 direct reports.
Job Responsibilities:
- Accountable for a project portfolio of up to 4 small projects (typically up to phase 2), or 1-2 highly complex /late stage projects (typically phase 3 and commercial).
- 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.
- Organization of laboratory activities.
- 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 of cleanliness of laboratory and workspace.
- Self-sufficiently designs and executes projects or experiments with hands on involvement.
Key Skills:
- Personality and disposition to manage professionals effectively in a matrix system
- Mature stable person with a positive and dynamic demeanour.
- High flexibility, superior communication, time-management and team-working skills.
- Ability to work independently and to take initiative.
- Ability to complete assignments, meeting quality- and time-oriented objectives.
- Strong skills in timeline development and management.
Requirements:
- College-, or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering.
- 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
- 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.
- Proficient in English.
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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