AB
AbbVie
2 Monate

Associate Director/Director CMC Product Development(m/w/x)

Management
Vollzeit
Keine Angabe
Ludwigshafen am Rhein

In this role, you oversee CMC product development, ensuring compliance and quality while managing projects and budgets. You collaborate with regulatory authorities and internal teams to drive strategic initiatives and maintain effective communication.

Lass KI die perfekten Jobs für dich finden!

Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.

Anforderungen

  • •Bachelor’s Degree with 10 years experience
  • •Master’s Degree with 8 years experience
  • •PhD with 6 years experience
  • •2-6 years working experience in similar role
  • •Excellent scientific writing skills
  • •Excellent verbal communication skills
  • •Good working knowledge of regulatory requirements
  • •Familiarity with scientific instrumentation
  • •Good knowledge of drug development process
  • •CMC interdisciplinary experience and expertise
  • •Negotiating and influencing skills
  • •Leadership skills
  • •Creative entrepreneurial thinking
  • •High morale and collaboration in teams
Bachelor-Abschluss
ODER
Master-Abschluss
ODER
Doktor / Ph.D.

Berufserfahrung

2–6 Jahre

Deine Aufgaben

  • •Represent CMC areas on the AST.
  • •Ensure high-quality science and compliance.
  • •Participate in meetings with regulatory authorities.
  • •Create CMC development plans with timelines and risks.
  • •Lead PPDST and CMC development teams for projects.
  • •Conduct periodic reviews for phase transition criteria.
  • •Review contracts with third-party manufacturers.
  • •Develop budget needs and obtain resources.
  • •Drive legal and financial aspects of outsourcing.
  • •Build relationships with external partners and stakeholders.
  • •Demonstrate strong negotiating and leadership skills.
  • •Lead due diligence for in-licensing opportunities.
  • •Manage multiple projects using a matrix approach.
  • •Negotiate for additional resources as needed.
  • •Implement creative approaches for resource efficiency.
  • •Provide feedback to functional managers on team growth.
  • •Ensure strategic alignment with Development Sciences functions.
  • •Integrate pre-clinical development plans with global teams.
  • •Support CMC functional initiatives and strategies.
  • •Promote scientific thinking and manage quality results.
  • •Ensure compliance with regulatory and safety requirements.
  • •Stay updated on global technical and regulatory developments.
  • •Communicate plans and risks to management regularly.
  • •Ensure quality of dossiers for health authorities.

Sprachen

Englisch – verhandlungssicher

Deine Vorteile

Abwechslungsreiche Aufgaben

  • •Diverse work environment

Lockere Unternehmenskultur

  • •Open corporate culture

Attraktive Vergütung

  • •Attractive salary

Mentoring & Coaching

  • •Intensive onboarding process

Flexibles Arbeiten

  • •Flexible work models

Gesundheits- & Fitnessangebote

  • •Comprehensive health programs

Mitarbeiterrabatte

  • •Company social benefits

Karriere- und Weiterentwicklung

  • •Wide range of career opportunities
  • •Top-tier development opportunities
  • •Strong international network
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.

Ähnliche Jobs direkt in deine Inbox?