​Analytical Development Manager

​Analytical Development Manager

Work Location: Allschwil, Switzerland

About the Role:

A pharmaceutical business is seeking a dedicated and experienced Manager in Analytical Development-Quality Control (AD/QC). This role is pivotal in ensuring that Drug Substance (DS) and Drug Product (DP) meet the highest quality standards and comply with GMP and regulatory guidelines.

Key Responsibilities:

• Team Management: Lead and manage a team of up to 3 direct reports.

• Project Oversight: Handle 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).

• Laboratory Organization: Oversee laboratory activities, ensuring adherence to Guidelines and SOPs.

• Method Development: Develop, optimize, and implement analytical methods for various determinations, including purity, stability, and cleaning verification/validation.

• Project Representation: Represent AD/QC in technical project team and CMC team meetings.

• Analytical Studies: Conduct release, retest, stability studies, transfer, and validation analyses.

• Documentation: Ensure proper documentation of all analytical activities according to Good Documentation Practices.

• Data Review: Review, interpret, and document analytical data from various studies.

• Protocol Writing: Write and review analytical protocols and reports, and establish specifications.

• Equipment Maintenance: Ensure adequate maintenance and operation of analytical equipment according to GMP.

• Document Drafting: Draft and review CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.

• Qualification Plans: Organize GMP-(re)qualification and validation of analytical equipment with external companies.

• Training: Ensure initial and continuing training of AD/QC personnel and adapt training according to business needs.

• Laboratory Cleanliness: Maintain cleanliness of laboratory and workspace.

• Project Execution: Independently design and execute projects or experiments with hands-on involvement.

• Scientific Review: Independently review scientific work in project-related activities.

• Material Availability: Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.

• External Contacts: Act as a contact for 3rd parties, such as CMOs and CROs, for defined analytical tasks.

• Novel Techniques: Independently evaluate and develop novel analytical techniques and instrumentation.

• Workload Management: Leverage workload of project members to ensure timelines and budget are met.

• Regulatory Submissions: Establish source documents for IND, IMPD, and NDA/MA submissions, respond to agency questions, and interact with Health Authorities.

• Troubleshooting: Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks.

• Timeline Management: Set and accomplish product development timelines in collaboration with formulation scientists.

• GMP Laboratory Management: Manage the GMP laboratory and employees.

• Analytical Expertise: Provide analytical expertise for defined drug substances and/or drug products.

• Communication: Summarize, defend, and communicate results and product quality issues to management.

• Outsourcing Management: Manage the outsourcing of analytical activities to CROs/CMOs, including supplier selection input.

• Technology Transfer: Participate in technology transfer between laboratories, both internal and external.

Qualifications:

• Proven experience in pharmaceutical analytical development and quality control.

• Strong leadership and project management skills.

• In-depth knowledge of GMP and regulatory guidelines.

• Excellent communication and documentation skills.

• Ability to work independently and as part of a team.

Apply today to be part of a dynamic and innovative team!