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Senior Specialist, Drug Product QC

Are you passionate about analytical chemistry?  Do you thrive in a collaborative environment that spans functions and cultures? 

If so, now is your chance to join the Drug Product QC team in an innovative and fast-growing biotech company as our new Senior Specialist. 

Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.

Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.

We are seeking an experienced Senior Specialist to join our growing team. As a key member of the Ascendis Pharma QC team, you will play a central role in coordinating analytical matters between Ascendis and different Contract Manufacturing Organizations (CMOs) as well as establishing and maintaining oversight over stability studies. You will be involved in all aspects of QC testing and handling of stability studies at our CMOs including validation, trouble shooting, trending and optimization. As we are currently submitting our products in many countries preparing regulatory documentation and answering questions from different authorities will be a part of the job. So, the success criterion in the job will be to ensure continuous good relations and alignment with CMOs and to ensure that analytical activities are executed according to regulatory requirements and in a scientifically sound manner. You will join the Drug Product QC team of five colleagues and report to Senior Director Lars Bo Ekhart Jensen, based in Hellerup.  

Your key responsibilities will be:  

  • Oversight and coordination of analytical activities at the CMOs 
  • Support the CMOs in decisions regarding the analytical methods e.g. validation strategy, laboratory investigations, method optimization. 
  • Give input or participate directly with the CMO in trouble shooting in connection with adverse events in the laboratory 
  • Planning and follow up on projects initiated at the CMOs 
  • Facilitate and support analytical performance and efficiency improvements 
  • Review and approve analytical documents e.g. laboratory investigations, validations, protocols, reports, and deviations  
  • Support regulatory documentation, follow-up on post-approval commitments and answering regulatory questions on method- and stability related aspects to the authorities 
  • Support our partners in different countries in preparing submission packages for the local authorities 
  • Stay updated with scientific and regulatory development in areas of analytical testing, analytical methods, analytical validation, and stability testing 
  • Contribute to establishing a strong QC organization within Ascendis Pharma  

 

Qualifications and Skills:  

  • You hold a relevant academic degree – preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like 
  • You have at least 8 years of experience from the pharmaceutical industry within chemical analysis, especially chromatographic methods (HPLC/UPLC, LC-MS, SE-HPLC), either from an Analytical Development Laboratory or from a QC Laboratory. 

Furthermore, it is an advantage if you have experience with:  

  • Collaboration and communication with external stakeholders enabling you to guide project teams at CMOs through conceptual as well as specific practical discussions.  
  • Management of stability programs, generation of protocols and reports, sample management and compilation of results  

Key personal competencies:  

You are a strong team player and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key. To succeed in this role, we expect you to be structured and systematic in your approach to solving tasks. As the job involves many stakeholders and coordination of activities both internally and externally, you thrive on being in contact with new people and you are proficient in English, both written and spoken.  You know how to maintain a constructive working environment and are used to work with stakeholders to support product supply programs and ensure adherence to project timelines. You enjoy having a broad network and know how to secure an acceptable compliance level at CMOs with different approaches to GMP. You enjoy sharing knowledge and participating actively in projects and cross functional meetings. You are used to establishing overviews, preparing and following plans, and finding smarter ways of doing things are key goals for you.  

 

Travel: 5-15 days per year.  

Office: Denmark, Tuborg Boulevard 12, 2900 Hellerup   

 

Apply now  

Applications will be evaluated when received, so please apply as soon as possible.  

All applications must be submitted in English and are treated confidentially.  

  

For more details about the position or the company, please contact Lars Bo Ekhart Jensen, Sr. Director, +45 3080 5829, lbej@ascendispharma.com, or visit our website www.ascendispharma.com   

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Average salary estimate

$105000 / YEARLY (est.)
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What You Should Know About Senior Specialist, Drug Product QC, Ascendis Pharma

Are you excited about the world of analytical chemistry? If you find joy in working collaboratively across various functions and cultures, becoming a Senior Specialist in Drug Product QC at Ascendis Pharma might be your next big adventure! Ascendis Pharma is a rapidly expanding global biopharmaceutical company dedicated to making a meaningful impact in the lives of patients. With locations stretching from Denmark to the United States, we are guided by our core values of Patients, Science, and Passion as we develop innovative therapies using our TransCon® drug development platform. In this crucial role, you will coordinate analytical activities with our Contract Manufacturing Organizations (CMOs), helping ensure they align with regulatory requirements while maintaining scientific integrity. Your responsibilities will include overseeing analytical testing processes at our CMOs, troubleshooting laboratory events, and reviewing essential documents such as protocols and reports. In doing so, you will foster strong relationships with our partners and support the preparation of regulatory submissions and responses. To thrive, you'll need a Master’s degree in a relevant field and at least 8 years of pharmaceutical industry experience, primarily with chemical analysis and chromatographic methods. We're looking for a proactive team player with an entrepreneurial spirit who thrives in dynamic environments. If you're ready to contribute to a forward-thinking organization that values innovation, we invite you to apply and join our friendly Drug Product QC team, reporting to Senior Director Lars Bo Ekhart Jensen.

Frequently Asked Questions (FAQs) for Senior Specialist, Drug Product QC Role at Ascendis Pharma
What are the key responsibilities of a Senior Specialist, Drug Product QC at Ascendis Pharma?

As a Senior Specialist, Drug Product QC at Ascendis Pharma, you'll engage in overseeing and coordinating analytical activities with our Contract Manufacturing Organizations (CMOs), providing vital input on method optimization, troubleshooting laboratory issues, and ensuring all analytical tasks comply with regulatory standards. Additionally, you'll assist in the creation of regulatory submissions and maintain communication with various stakeholders, enhancing the QC framework within the organization.

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What qualifications are required for the Senior Specialist, Drug Product QC position at Ascendis Pharma?

To excel as a Senior Specialist in Drug Product QC at Ascendis Pharma, candidates should hold a relevant Master’s degree, preferably in Chemistry, Engineering, or Pharmacy, coupled with at least 8 years of experience within the pharmaceutical industry. Strong expertise in chromatographic methods like HPLC and LC-MS is highly advantageous, as is experience with managing stability programs and collaborating with external partners.

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How does the Senior Specialist, Drug Product QC role contribute to patient care at Ascendis Pharma?

The Senior Specialist, Drug Product QC role directly impacts patient care at Ascendis Pharma by ensuring the quality and efficacy of biopharmaceutical products. By overseeing analytical processes and maintaining regulatory compliance, this role helps guarantee that our innovative therapies meet the highest standards before reaching patients, ultimately contributing to better health outcomes.

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What is the team structure like for the Senior Specialist, Drug Product QC position at Ascendis Pharma?

Joining the Drug Product QC team at Ascendis Pharma means working alongside five dedicated colleagues, all supporting shared goals. As a Senior Specialist, you will collaborate closely with your teammates and report to Senior Director Lars Bo Ekhart Jensen, fostering a supportive and innovative working environment where knowledge sharing and teamwork thrive.

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What skills and personal qualities are important for a Senior Specialist, Drug Product QC at Ascendis Pharma?

In the role of Senior Specialist, Drug Product QC at Ascendis Pharma, it's vital to be a strong communicator and collaborator, with an entrepreneurial mindset to adapt to challenges. A structured and systematic approach to problem-solving is equally important, as well as a genuine passion for fostering relationships and encouraging compliance among CMOs to ensure success within the team.

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Common Interview Questions for Senior Specialist, Drug Product QC
Can you describe your experience with chromatographic methods in quality control?

When answering this question, focus on specific experiences with HPLC, UPLC, or LC-MS techniques. Mention successful projects where you employed these methods and any challenges faced, emphasizing your troubleshooting skills and how you contributed to improvements in the quality control processes.

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How do you prioritize tasks when working with multiple stakeholders at CMOs?

Explain your approach to task prioritization by highlighting your organizational skills. Discuss how you assess the urgency and importance of various projects, strive to maintain open communication with all stakeholders, and how you ensure that all critical deadlines are met.

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What strategies do you use to maintain compliance with regulatory standards?

Elaborate on your familiarity with regulatory requirements and your proactive strategies for ensuring compliance, including thorough documentation, regular communication with CMOs, and staying updated on industry regulations. Providing examples of how you've effectively maintained compliance in past roles will enhance your answer.

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Describe a time when you had to troubleshoot an issue in the lab.

Share a specific instance where you encountered a laboratory issue. Detail the problem, your diagnosis, the steps you took to resolve it, and the results. This demonstrates your problem-solving and analytical thinking skills, which are vital in a role focused on quality control.

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How do you handle conflicting priorities from different teams?

Discuss your approach to managing conflicts, such as open communication and setting clear expectations. Explain how you negotiate timelines and workload with various teams to find solutions that work for everyone while keeping the project moving forward.

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What experience do you have with regulatory submissions?

When answering, highlight your experience in preparing regulatory documentation, referencing any specific submission processes you've been involved with. Discuss how you collaborate with cross-functional teams to compile accurate and complete submissions to ensure they meet regulatory standards.

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How do you keep yourself updated on the latest developments in analytical testing?

Share your methods for staying informed, such as reading industry publications, attending workshops or seminars, and participating in professional networks. This shows your commitment to professional growth and your desire to remain current in the rapidly evolving biotech landscape.

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Can you describe a successful project you led or contributed to in your previous roles?

Provide a clear and concise narrative of a project, focusing on your specific contributions, any challenges faced, and the outcomes achieved. Emphasize teamwork, collaboration with CMOs, and how your efforts led to improvements in processes or product quality.

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What interpersonal skills do you believe are crucial for a Senior Specialist, Drug Product QC?

Discuss the importance of effective communication, collaboration, and relationship-building with external stakeholders and internal teams. Providing examples of how these skills have benefited your past roles will strengthen your answer.

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Why do you want to work for Ascendis Pharma as a Senior Specialist in Drug Product QC?

Express your passion for the role and the company's mission. Highlight how your values align with Ascendis Pharma's focus on patients and innovative science, and discuss your excitement about the opportunity to make a meaningful impact as part of a forward-thinking team.

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