Senior Formulation and Filling Process Development Scientist/Engineer

Senior Formulation and Filling Process Development Scientist/Engineer

Galderma

Uppsala, Sweden

Job Description

Are you an experienced formulation scientist or fill/finish process development professional with experience in aseptic pharmaceuticals or medical devices? If so, this could be the role for you as we are now hiring a Senior Scientist/Engineer in our Injectable Development team.

Elevate your career by joining Galderma for a role that involves subject-matter expertise in the field of protein and polymer product formulation, process development, scale up and process transfer to manufacturing facilities for both injectable medical devices and pharmaceuticals. As an integral part of the Product Science department, you will be highly involved in developing new products to further expand Galderma’s portfolio and building our parenteral technology capabilities.

Key responsibilities

• Act as a Subject Matter Expert (SME) for projects and provide required experimental designs, data and author technical reports compliant with regulatory guidelines and industrial standards.
• Lead activities related to filling and sterilization processes of injectable products under development, including work with regulatory submissions, design control, specifications, and risk assessments.
• Represent the Process Science team in cross functional product development teams with other internal departments and external partners.
• Participate in key Product Science activities to assess impact of new regulations and implement appropriate changes
• Keep up to date with innovations in parenteral formulations and filling, share and implement new technology in the organization.

Skills & Qualifications

• Expertise in the formulation and process development of prefilled syringes and/or vials. Experience transferring and validating processes to internal manufacturing facilities and Contract Manufacturing Organizations (CMOs)
• Experience with biopolymers or protein characterization for injectable medical devices and/or pharmaceutical products and the development of terminal sterilization processes is desirable.
• Familiarity with filling machines and clean room environments as well as aseptic techniques and microbiological controls
• Knowledge of cGMP and Design Control in regulatory controlled work environments (e.g. ISO 13485, 21 CFR820, ICHQ8, 21CFR210/211, etc.) and experience preparing regulatory filings and supporting documentation
• Fluent in English, ability to work in Swedish is also desirable.
• Strong communication skills, providing guidance and information to internal and external stakeholders
• University degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, Biotechnology or similar technical field and 8 years experience in the pharmaceutical or medical device field.