CMC Specialist

☞ Sintetica SA

View: 173

Update day: 26-03-2024

Location: Mendrisio Ticino TI

Category: Sales Pharmaceutical / Chemical / Biotech

Industry:

Job type: Temps plein, Durée indeterminée

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Job content

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.
People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.
To strengthen our Pharmaceutical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a CMC Specialist (fulltime position).


Position summary


The CMC Specialist will manage projects related to both:
  • Preparation of new finished products dossier.
  • Quality change dossiers to be approved.


He/She will operate under the direct coordination of the CMC Strategy Manager and in collaboration with the Pharmaceutical Development Team and the colleagues in the Scientific Affairs Department. He/She will follow the project starting from the input, which could be a new product dossier or a change implementation in an approved dossier, until the submission of the complete CMC part (Module 3 and 2.3) or specific sections.


Essential tasks and responsibilities


  • Collaborations with Regulatory Affairs and Technical Departments to define regulatory CMC strategies and identification of potential regulatory risks.
  • Identification of the required documentation for CMC submissions and negotiation with the Technical Departments of the approved technical data and documents delivery.
  • Review of post-approval CMC changes (Change Controls) and assessment of the regulatory impact on the affected dossiers in collaboration with Regulatory Affairs. Definition of the regulatory strategies for variation and preparation of the concerned CMC section.
  • Planning and preparation of CMC documentation for both new product registration and variation applications.
  • Collecting the responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
  • Preparation of meeting materials and attending to Health Authority advice related to CMC drug development activities and submissions.
  • Responsible to identify critical CMC/CMC regulatory issues, drive strategies and implementation for their resolution.
  • Able to drive cross functional scientific/technical expertise in pharmaceutical development and sound knowledge of worldwide regulatory guidelines to proactively drive cross functional CMC content, in close collaboration with development project management and technical functions.


Required skills and core competences


  • Bachelor’s degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)
  • +5 years of experience in scientific/ technical line functions (e.g., upstream/ downstream/ analytical or drug product development)
  • Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management
  • Knowledge of EU/US/Swiss regulations related to the eCTD CMC Part (Module 3 and 2.3) and guidelines related to manufacturing equipment, process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation.
  • Substantial work experience in analytical development, scale-up manufacturing process, preferably with cGMP experience.
  • Knowledge of CMC requirements for regulatory filings and working in a matrix organization highly desired.
  • Good experience in the use of MS software and documental tools.
  • Very good English communication and writing skills. The knowledge of French will be considered an asset.
  • Excellent communication skills, proactivity, autonomy, precision, teamwork attitude, excellent planning skills, good stress management
  • Management and organizational skills, flexibility, learning agility and strategic thinking.
  • Ability to work effectively within a cross-functional team.
  • Flexible to work simultaneously on multiple projects, able to adjust CMC plans to deal with changes and obstacles.
  • Commitment to continuous improvement.
  • Adaptability to a multicultural environment.


We offer


Fulltime permanent employment in a young working environment and positive culture.
Sintetica promotes diversity and gender equality.

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Deadline: 10-05-2024

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