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NONovartis Pharmaceutical Manufacturing GmbH

Drug Product Project Leader – Associate Director Science & Technology(m/w/x)

Schaftenau
from 78,383.9 / year
Full-time, Part-timeOn-siteSenior
Data Science
Apply now

Leading biologics formulation and process development for complex drug products. 8+ years industry experience with QbD and tech transfers required. Attractive incentive program, modern pension scheme.

Requirements

  • Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
  • Minimum 8 years relevant industry experience
  • Focus on drug product formulation and process development
  • Experience in technology transfers and regulatory submissions
  • Proficient in quality principles, Quality by Design (QbD)
  • Proficient in Good Manufacturing Practice (GMP)
  • Proficient in regulatory requirements
  • Experience in Investigational New Drug (IND) / Biologics License Application (BLA) submissions
  • Excellent leadership skills
  • Excellent interdisciplinary skills
  • Track record of leading cross-functional global teams
  • Track record of leading cross-functional global projects
  • Excellent project management skills
  • Excellent communication/presentation skills
  • Excellent stakeholder management skills
  • Excellent scientific/technical writing skills
  • Openness to digital transformation
  • Proactiveness in adopting new digital tools
  • Proactiveness in adopting Artificial Intelligence (AI)-driven solutions
  • Strategic mindset
  • Strong business acumen
  • Responsible professional
  • Objective-driven professional
  • Resilient professional
  • Thrives in collaborative, cross-functional environments
  • Eager to embrace new challenges
  • Eager to expand expertise

Tasks

  • Lead technical development strategy for complex biologics
  • Represent Drug Product Development in CMC teams
  • Ensure delivery of agreed milestones
  • Champion scientific excellence in drug product formulation
  • Champion scientific excellence in process development
  • Champion scientific excellence in technical transfers
  • Champion scientific excellence in process validation
  • Champion scientific excellence in product registration
  • Lead global drug product sub-team
  • Coordinate global drug product sub-team
  • Foster sub-team member growth through coaching
  • Be accountable for timely source document delivery
  • Review regulatory documents (CMC modules, briefing books)
  • Interact with Health Authorities
  • Set priorities for the drug product sub-team
  • Communicate project strategy and requirements
  • Engage stakeholders across CMC teams
  • Engage stakeholders across sub-teams
  • Engage stakeholders across line functions
  • Engage stakeholders across internal/external partners
  • Assess resource needs
  • Assess project budget needs
  • Strategically evaluate external assets for development
  • Integrate external assets for development

Work Experience

  • 8 years

Education

  • Doctoral / PhD

Languages

  • English – Business Fluent

Tools & Technologies

  • Quality by Design (QbD)
  • Good Manufacturing Practice (GMP)
  • Investigational New Drug (IND)
  • Biologics License Application (BLA)
  • Artificial Intelligence (AI)

Benefits

Bonuses & Incentives

  • Attractive incentive program

Retirement Plans

  • Modern company pension scheme

Childcare

  • Childcare facilities

Learning & Development

  • Learning and development opportunities

Career Advancement

  • Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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