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NONovartis Pharmaceutical Manufacturing GmbH

Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)

Schaftenau
from 65,605.54 / year
Full-timeOn-siteManagement

Leading analytical strategy for Biologics DS/DP process development using Quality by Design principles. 3+ years (PhD) or 6+ years (MSc) in biopharma with Biologics DS/DP process development expertise required. Matrix leadership role.

Requirements

  • University degree in pharmaceutical technology, biotechnology, biochemistry, chemistry, chemical engineering, or relevant natural science discipline
  • At least 3 years (PhD) or 6 years (MSc) of working experience in the (bio)pharmaceutical industry
  • Advanced knowledge in Analytical Development
  • Expertise in Biologics DS and DP process development applying QbD principles
  • Solid project management skills
  • Excellent collaboration skills
  • Proficiency in oral and written English; German is beneficial
  • Strong proficiency in digital technologies

Tasks

  • Lead analytical project activities as a matrix leader
  • Establish physicochemical analytical strategies based on Quality by Design principles
  • Interpret and contextualize analytical results
  • Apply data and digital solutions to enhance efficiency
  • Lead or support root cause investigations and issue resolution
  • Monitor project progress and represent analytical aspects in meetings
  • Oversee in-house and outsourced analytical work to meet timelines
  • Author and review scientific reports and support regulatory submissions
  • Act as an analytical expert during audits and inspections
  • Manage multiple priorities and proactively communicate challenges
  • Contribute to budget and resource planning while maintaining cost awareness
  • Build strong relationships with internal teams and external partners
  • Promote knowledge sharing and present results internally
  • Contribute to publications, presentations, and patents
  • Evaluate new analytical technologies and develop innovative methods
  • Ensure alignment with scientific standards and contribute to digitalization efforts
  • Respond to analytical queries during audits and regulatory reviews
  • Ensure data integrity in CMC modules

Work Experience

  • 3 - 6 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic
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