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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-timeWith Home OfficeSenior
Data Science
Apply now

Leading biologics formulation and process development for IND/BLA submissions. Ph.D. and 8+ years industry experience required. Worldwide career possibilities, childcare facilities.

Requirements

  • Ph.D. in pharmaceutical technology, biotechnology, chemical engineering or equivalent
  • Minimum 8 years relevant industry experience
  • Proficiency in quality principles, QbD, GMP, regulatory requirements
  • Experience in IND/BLA submissions
  • Excellent leadership skills
  • Interdisciplinary skills
  • Track record of leading cross-functional global teams
  • Track record of leading 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 AI-driven solutions
  • Strategic mindset
  • Strong business acumen
  • Responsible professional
  • Objective-driven professional
  • Resilient professional
  • Thrives in collaborative environments
  • Thrives in cross-functional environments
  • Eager to embrace new challenges
  • Eager to expand expertise
  • Budget Management
  • Coaching Skills
  • Data Science
  • Experiments Design
  • Laboratory
  • Problem Solving Skills
  • Process Simulation
  • R&D
  • Waterfall Model

Tasks

  • Lead technical development strategy for 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)
  • Review regulatory documents (briefing books)
  • Interact with Health Authorities
  • Respond to Health Authority information requests
  • Manage Health Authority inspections
  • Set priorities for the drug product sub-team
  • Communicate overall project strategy
  • Communicate project requirements
  • Ensure effective stakeholder engagement
  • Assess resource needs
  • Consolidate resource needs
  • Assess project budget needs
  • Consolidate project budget needs
  • Strategically evaluate external assets
  • Integrate external assets for development
  • Align external assets with portfolio strategy

Work Experience

  • 8 years

Education

  • Doctoral / PhD

Languages

  • English – Business Fluent

Tools & Technologies

  • IND
  • BLA
  • 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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