Associate Director / Director CMC Product Development (m/f/d)

Your Profile:

• Bachelor's Degree with at least 10 years of experience in a variety of relevant functions required; Master's Degree with at least 8 years of relevant experience required; or PhD with at least 6 years of relevant experience required. 2-6 years of working experience required in the same/similar role or in related CMC function.
  
• Must possess excellent scientific writing and verbal communication skills.
  
• Must have a good working knowledge of regulatory requirements and familiarity with relevant scientific instrumentation and techniques
  
• Good knowledge of pharmaceutical drug development process
  
• Must have CMC interdisciplinary experience and expertise.
  
• Possess negotiating, influencing, leadership skills
  
• Creative in implementing entrepreneurial thinking and making smart business decisions.
  
• Ensure high level of morale and collaboration in cross-functional teams to maximize team impact and output.

Your Tasks:

• Representing all CMC areas on the AST serving as spokesperson for the CMC project team and ensuring information flow among the AST and all line functions. Ensuring high quality science, technology, deliverables, and certifies compliance with global regulatory and quality requirements. Participating in meetings with Regulatory Authorities, responds to regulatory queries, and participates in communications and meetings with regulatory agencies. Taking accountability for creating CMC development plan incl. timelines, risks and mitigations in collaboration with line functions and AST
  
• Leading PPDST and/or CMC development teams for assigned projects: scheduling meetings, developing agendas, issuing highlights, identifying risks and develops mitigation plans with technical functions. Conducting periodic reviews to ensure that phase transition criteria are met in the most efficient and resource effective manner. Asseting modalities may include new chemical entities (NCEs), new biological entities (NBEs), antibody-drug-conjugates (ADCs), toxins, and gene and cell therapies
  
• Reviewing contracts with Third Party Manufacturers and consultants. Developing budget needs in collaboration with AST, obtaining resources from functional areas and staying within the approved funding. Driving legal and financial aspects of outsourcing, contracts, and statements of work (SOW). Demonstrating excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrating strong negotiating, influencing, and leadership skills.
  
• Leading teams and partner interactions for new due diligence in-licensing opportunities and successfully transitioning leadership for programs where development is internalized.
  
• Managing a limited number of projects of various complexity utilizing matrix management approach. Negotiating for additional resources when required, influences project timelines to ensure proper completion of required activities. Implementing creative approaches to conserve resources, and achieve efficiency with respect to time, and budget. Providing feedback and input to functional managers and identifies growth needs for team members.
  
• Ensuring strategic alignment with other key Development Sciences functions, esp. Preclinical Toxicology/Biological Sciences and Quantitative, Translational and Analytical Sciences (QTAS)/ADME (adsorption, distribution, metabolism and excretion) to ensure key deliverables for asset advancement are met and risks and mitigation plans are in place. Integrating and implementing pre-clinical development plans and updates as necessary in collaboration with the global development teams and respective line functions.
  
• Supporting and implements CMC functional initiatives and across-asset strategies
  
• Promoting scientific and entrepreneurial thinking, encourages creativity and manages quality and results with respect to science, time, budget and resources.
  
• Ensuring compliance with regulatory, health, safety and environmental requirements. Staying abreast of developments in global technical, regulatory and compliance arena and industry practice.
  
• Apprising management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and general agency feedback. Responsible for the quality and effectiveness of dossiers and communication with health authorities at global level.

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