Senior Specialist, CMC Drug Product Formulation Development

As a Senior Specialist in CMC Drug Product Formulation Development at Ascendis Pharma, you will be responsible for strategizing the development of drug products and drug-device combination products. Your daily tasks will include conducting pharmaceutical development studies, preparing specifications, ensuring compliance with regulations, and writing regulatory documentation. You'll collaborate with cross-functional global teams and manage relationships with CROs and CMOs to facilitate product transfers and meet project timelines.

To qualify for the Senior Specialist role in CMC Drug Product Formulation Development at Ascendis Pharma, candidates should hold a Master’s or PhD in Pharmacy, engineering, chemistry, or a related field. Beyond this educational background, you need at least 7 years of experience in Biotechnology or Pharmaceutical Development, with a minimum of 3 years of direct experience in injectable formulation development, showcasing strong scientific leadership abilities.

Success as a Senior Specialist in CMC Drug Product Formulation Development at Ascendis Pharma requires a blend of strong scientific expertise, analytical skills, and the ability to work collaboratively within teams. Essential skills include project management to balance risks and timelines, excellent communication abilities for stakeholder interaction, and an entrepreneurial mindset that thrives in an innovative environment.

Yes, as a Senior Specialist in CMC Drug Product Formulation Development at Ascendis Pharma, you can expect to travel approximately 15-25 days per year. This travel may involve collaborating with cross-functional teams and partners to ensure effective product development and team alignment.

To apply for the Senior Specialist position in CMC Drug Product Formulation Development at Ascendis Pharma, you should submit your application in English. It's important to ensure your application is complete, as it will be evaluated upon receipt. For further information, you can also reach out directly to Ellen Nagato Watanabe, the director of Drug Product Formulation Development.

In responding to this question, reflect on specific projects you worked on that highlight your expertise in formulation development, including any challenges faced and how you overcame them. Be sure to emphasize your role in the team and the outcomes of the formulations developed.

Your answer should include strategies such as risk management, thorough planning, collaboration across teams, and the significance of adherence to regulatory standards. Highlight how you have applied these strategies in past experiences.

Discuss your approach to staying updated on regulatory requirements and how you incorporate these into development processes. Provide examples of specific compliance measures you have implemented in past roles.

This question allows you to showcase your relationship management skills. Talk about your experiences collaborating with CROs and CMOs, strategies for effective communication, and successes achieved through these partnerships.

Explain your project management skills, possibly mentioning tools or methodologies you use, such as Agile. Share an example where you successfully navigated deadlines while maintaining quality standards.

Discuss your familiarity with statistical methodologies relevant to drug formulation, such as Design of Experiments. Mention specific ways you have utilized statistical analysis to inform decision-making during product development.

Be prepared to narrate a specific challenge you encountered, detail your thought process in addressing it, and highlight the successful resolution and outcomes achieved, demonstrating your problem-solving skills.

Share your personal motivations, whether they stem from a passion for science, a commitment to improving patient lives, or interest in cutting-edge technologies. Highlight how this drive influences your work as a Senior Specialist.

Discuss your commitment to professional development through attending workshops, conferences, or engaging in relevant literature. Provide examples of how staying informed has positively impacted your work.

Reflect on Ascendis Pharma's values of innovation, collaboration, and patient focus. Draw connections between your work style, values, and experiences that align with the company’s culture, emphasizing how you would contribute to the team.