Analytical Development and Quality Control Manager
vor 1 Woche
Analytical Development and Quality Control Manager – 6255 URA
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, 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 is someone who 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:
- 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 SOPs.
- 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 documentation for implementation.
- Representation of AD/QC in technical project team and CMC team meetings.
- Conduct 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 and review analytical protocols and reports and establish specifications.
- Assure adequate maintenance and operation of analytical equipment according to GMP.
- Draft and review 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.
- Ensure initial and continuing training of AD/QC personnel and adaptation according to business needs.
- Ensure cleanliness of laboratory and workspace.
- Independently design and execute projects or experiments with hands-on involvement.
- Independently review scientific work in project-related activities.
- Ensure availability of adequate lab materials and justify 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.
- Leverage workload of respective project members to assure timelines and budget are met.
- Establish source documents for IND, IMPD, and NDA/MA submissions as well as respond to agency questions and interact with Health Authorities.
- 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 scientists.
- Responsible for the management of the GMP laboratory and employees.
- Responsible for the 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 previous success in a managerial function.
- In addition to knowledge of 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 detail. 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 take initiative.
- Proficient in English. Life-long learning mindset and a strong sense of accountability. Should actively seek 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 the ability to work with diverse teams of people with multiple perspectives and talents, capable of functioning as an 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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