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 into delivering products on the market over the next 5 years, is looking a AD/QC Manager  for a 12 months contract based in Basel.

 

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. An ideal candidate is someone who has Biology of chemical engineering background with a proven trackrecord 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 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.
  • Independently reviews scientific work in project related activities.
  • Ensures availability of adequate lab materials as well as justifies 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.
  • Leverages workload of respective project members to assure timelines and budget are met.
  • 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.
  • Set and accomplish product development timelines working closely with formulation scientist.
  • Responsible for the management of the GMP laboratory and employees
  • Responsible for the analytical expertise for defined ia drug substances and/or drug products
  • Summarizing, defending and communicating 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 the 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 details. 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.
  • Strong skills in timeline development and management.
  • Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams of people with multiple perspectives and talents, capable of functioning as 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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