The Analytical Scientist is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Analytical Scientist provides technical and scientific expertise to manage transfer/verification/validation of new methods for introducing new raw materials, drug substance (API), and drug product (Bulk). He / She supports investigation and troubleshooting of analytical issues (commercial or not). Additional duties includes participating to registration stability studies, participating to supplier qualification & supplier Audit, participating to cleaning validation and validation processes.

As a QC team member, the person filling this position supports all activities to continuously maintain the GMP status of the QC Laboratory.

Essential Job Functions:

• Manage analytical transfer projects involving various stakeholders, including customers and internal departments (QA, QC, Production, Suppliers, etc.)
• Responsible to introduction of new methods (Raw Materials, APIs and Drug products) in QC:
  • Evaluates method clients and identify blocking points
  • Performs or support feasibility experimental work as needed
  • Manages of the transfer/verification/validation protocols and reports
  • Implements methods, Manages the methods/specification documentation
  • Implements cleaning methods and participates to cleaning validation
• Performs analytical testing according to raw material and product release specifications (HPLC, UPLC, GC, UV/VIS, IR, dissolution, pH, conductivity, TOC, titration, weighing, wet chemistry experiments etc.).
• Performs review of analytical data.
• Support introduction of new technologies:
  • Works cross-functionally with QC support, the commercial team, QA, IT and other departments to select, purchase and qualify new technologies for the QC laboratory
  • Performs feasibility experimental work as needed
• Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory (for all that needs scientifical and technical expertise when appropriate (QC complaints included)).
  • Owns deviations, leads or supports laboratory investigations
  • Writes or reviews investigative testing plans or retest plans prior to execution
  • Defines corrective and preventive actions (CAPA)
• Maintains the GMP status of the laboratory and analytical methods.
• Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required.
• Communicates effectively with management regarding more complex issues.
• Conduct effective training of QC personal (QC analysts, QC scientists)
• Actively participates in inspections by health authorities and corresponding preparation
• Authors and updates documents, such as procedures, work instructions, protocols, reports and other QC documents
• Reviews and approves documents issued by QC team
• QC representative in transversal project
• This position is responsible to ensure all EHS requirements in the laboratory : Respects EHS procedures and rules
• Performs other tasks as assigned.

Job Requirements:

Experience / Education  

• Master or PhD degree in Life Sciences, Chemistry, Pharmacy or equivalent.
• 5 years of work experience in a GMP environment (pharmaceutical industry)

Knowledge / Skills / Abilities:

• Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
• Thorough knowledge of quality systems as well as deviations and investigations handling.
• Takes a structured and analytical approach to problem solving. Is familiar with problem-solving and investigation tools and methodologies
• Able to present topics as Subject Matter Expert to internal audience, external audience and at regulatory inspections and audits.
• Excellent scientific knowledge and hands-on experience of chromatography
  techniques (HPLC, UPLC, GC), dissolution, UV and IR techniques.
• Experience of analytical testing according to Ph. Eur., JP and USP requirements.
• Advanced knowledge of analytical method transfers and analytical method validation/verification.
• Advanced GMP documentation skills and technical writing skills (procedures, protocols, plans and reports)
• Experience in laboratory equipment qualification and software qualification.
• Advanced knowledge of Data Integrity principles, experience of audit trail review requirements.
• Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Effective verbal communication skills, ability to interact with different levels of the organization: manager, supervisor, peers, lab analysts, and other departments
• Ability to work collaboratively and cross-functionally in project teams.
• Fluent in English or French and professional command of the second language (written and verbal)

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.