Analytical Development and Quality Control Manager – 6255 URA
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas and committed to delivering products on the market over the next 5 years, is looking for an AD/QC Manager for a 12-month contract based in Basel .
Analytical Development / Quality Control (AD/QC) is responsible for the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines. An ideal candidate has a background in Biology or Chemical Engineering with a proven track record in a managerial role as a Senior Scientist within a pharmaceutical company.
Main Responsibilities:
Manage 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).
Organize laboratory activities and follow the processes defined in Guidelines and SOPs.
Develop, optimize, and implement analytical methods for purity, stability, cleaning verification/validation, excipients, content, and potentially genotoxic impurity determinations.
Represent AD/QC in technical project team and CMC team meetings.
Conduct release, retest, stability studies, transfer, and validation analyses.
Document all analytical activities according to Good Documentation Practices.
Review, interpret, and document analytical data including results from method development, release, retest, validation, stability, and transfer.
Write and review analytical protocols and reports and establish specifications.
Ensure adequate maintenance and operation of analytical equipment according to GMP.
Draft and review CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.
Organize GMP (re)qualification and validation of analytical equipment with external companies.
Elaborate qualification plans and review qualification documents.
Ensure initial and continuing training of the personnel of AD/QC.
Maintain cleanliness of laboratory and workspace.
Design and execute projects or experiments with hands-on involvement.
Review scientific work in project-related activities.
Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.
Act as contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
Evaluate and develop novel analytical techniques and instrumentation.
Leverage workload of respective project members to assure timelines and budget are met.
Establish source documents for IND, IMPD, and NDA/MA submissions.
Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks.
Set and accomplish product development timelines working closely with formulation scientists.
Manage the GMP laboratory and employees.
Provide analytical expertise for defined drug substances and/or drug products.
Summarize, defend, and communicate 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 success in a managerial function.
Strong background in analytical chemistry and knowledge of GMP/regulatory requirements.
Ability to manage professionals effectively in a matrix system with diligent attention to detail.
High flexibility, superior communication, time-management, and team-working skills.
Proficient in English with a lifelong learning mindset and a strong sense of accountability.
Ability to complete assignments, meeting quality and time-oriented objectives.
Strong skills in timeline development and management.
Excellent problem-solving skills and ability to work with diverse teams.
Broad knowledge in analytical chemistry and basic knowledge in synthetic chemistry, drug substance processing, and/or formulation development.
Experience in the development and performance of analytical tests for a variety of drug substances and products.
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