Manager in Analytical Development-Quality Control

Manager in Analytical Development-Quality Control

Duration: TBD

RESPONSIBILITIES AND TASKS:
Analytical Development / Quality Control (AD/QC) is dealing with 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.

• 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 of cleanliness of laboratory and workspace.
• Independently designs and executes projects or experiments with hands on involvement.
• 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.
• Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.

REQUIRED QUALIFICATIONS AND EXPERIENCE:

• College or university-degree or equivalent education in the field of chemistry, biochemistry, pharmacy, 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.
• 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.

Apply:
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.