Lead Biotherapeutics Process Development & Tech Transfer

Johnson & Johnson Co.

Schaffhausen

On-site

CHF 180,000 - 240,000

Full time

8 days ago

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Job summary

Johnson & Johnson Innovative Medicine in Schaffhausen is recruiting a Principal Scientist to lead late-stage process development and tech transfer for biotherapeutics fill/finish. The role partners with MSAT, QA, Regulatory and other groups to ensure compliant manufacturing processes.

The ideal candidate has a Master or PhD and 8+ years in biopharmaceutical development, with hands-on experience in biologics, transfer to manufacturing, and strong cross-functional leadership.

Qualifications

  • Master degree or PhD in a technical field with at least 8 years of experience in biopharmaceutical development and manufacturing.
  • Proven expertise in biologics drug product development and fill/finish operations.
  • Strong collaboration across MSAT, Quality, Regulatory and other functions.

Responsibilities

  • Lead late-stage process development, technology transfer, process validation and regulatory filings between manufacturing sites.
  • Author tech transfer documents and validation/CMC-related reports.
  • Support external manufacturers in troubleshooting parenteral products.
  • Act as SME for fill/finish manufacturing during audits and provide technical feedback to development teams.
  • Partner with cross-functional groups to ensure processes align with J&J IM platforms and regulatory expectations.
  • Contribute to defining strategies for new product introductions in fill/finish.
  • Bring independent work capability and proactive problem-solving.
  • Travel 10-30% as required.

Skills

Biologics development
Technology transfer
Parenteral manufacturing
Regulatory submissions
Cross-functional collaboration

Education

Master or PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or related field

Job description

Johnson & Johnson Innovative Medicine in Schaffhausen is recruiting a Principal Scientist to lead late-stage process development and tech transfer for biotherapeutics fill/finish. The role partners with MSAT, QA, Regulatory and other groups to ensure compliant manufacturing processes.

The ideal candidate has a Master or PhD and 8+ years in biopharmaceutical development, with hands-on experience in biologics, transfer to manufacturing, and strong cross-functional leadership.

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