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

Beschreibung

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.

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

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.

Benefits