Manager in Analytical Development-Quality ControL

vor 12 Stunden

Basel, Schweiz Discover International Vollzeit
Manager in Analytical Development-Quality Control

Job Title: Manager in Analytical Development-Quality Control

Schedule: Fulltime (100%) / 40 hours per week

Duration: 12 months

RESPONSIBILITIES AND TASKS

  1. Manage a team of up to 3 direct reports.
  2. 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).
  3. Organize laboratory activities following defined processes in Guidelines and SOPs.
  4. Develop, optimize, and implement analytical methods for purity, stability, cleaning verification/validation, excipients, content, and potentially genotoxic impurity determinations.
  5. Represent AD/QC in technical project team and CMC team meetings.
  6. Conduct release, retest, stability studies, transfer, and validation analyses.
  7. Document all analytical activities according to Good Documentation Practices.
  8. Review, interpret, and document analytical data.
  9. Write and review analytical protocols and reports and establish specifications.
  10. Ensure adequate maintenance and operation of analytical equipment according to GMP.
  11. Draft and review CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.
  12. Organize GMP (re)qualification and validation of analytical equipment with external companies.
  13. Elaborate qualification plans and review qualification documents.
  14. Ensure initial and continuing training of AD/QC personnel.
  15. Maintain cleanliness of laboratory and workspace.
  16. Independently design and execute projects or experiments.
  17. Review scientific work in project-related activities.
  18. Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.
  19. Serve as contact for 3rd parties for defined analytical tasks.
  20. Evaluate and develop novel analytical techniques and instrumentation.
  21. Leverage workload of project members to assure timelines and budget are met.
  22. Establish source documents for IND, IMPD, and NDA/MA submissions.
  23. Design and lead laboratory work to support troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks.
  24. Set and accomplish product development timelines working closely with formulation scientists.
  25. Manage the GMP laboratory and employees.
  26. Summarize, defend, and communicate results and product quality issues to management.
  27. Manage the outsourcing of analytical activities to CROs/CMOs.
  28. Participate in technology transfer between laboratories.
  29. Contribute to the ownership and advancement of lab instrumentation and work processes.

REQUIRED QUALIFICATIONS AND EXPERIENCE

  1. College or university degree in chemistry, biochemistry, pharmacy, biology, or chemical engineering with 12+ years BS, 9+ years MS, or 2+ years PhD experience in the pharmaceutical industry.
  2. Strong background in analytical chemistry and knowledge of GMP/regulatory requirements.
  3. Ability to manage professionals effectively in a matrix system.
  4. Diligent attention to detail and willingness to travel.
  5. Positive and dynamic demeanor with superior communication, time-management, and team-working skills.
  6. Ability to work independently and take initiative.
  7. Proficient in English with a life-long learning mindset.
  8. Strong skills in timeline development and management.
  9. Excellent problem-solving skills and ability to work with diverse teams.
  10. Broad knowledge in analytical chemistry and basic knowledge in synthetic chemistry, drug substance processing, and formulation development.
  11. Experience in the development and performance of analytical tests for various drug substances and products.
Seniority level

Mid-Senior level

Employment type

Contract

Job function

Analyst and Science

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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