Pharmaceutical Specialist

3 days ago


Gentofte, Gentofte Kommune, Denmark Ascendis Pharma Full time
Senior Specialist, CMC Drug Product Formulation Development

A highly skilled Senior Specialist is required to join our team at Ascendis Pharma. If you have experience in pharmaceutical development from biotech or pharmaceutical industry and are passionate about drug product formulation development, then this could be the ideal opportunity for you.

About Us:

Ascendis Pharma is a leading biopharmaceutical company with a focus on developing innovative treatments for patients worldwide. Our commitment to excellence and our dedication to delivering high-quality products has earned us a reputation as a trusted partner in the pharmaceutical industry.

Our Mission:

To deliver life-changing treatments that make a meaningful difference in patients' lives. We achieve this through our passion for science, our commitment to innovation, and our drive to push boundaries.

The Role:

We are seeking a highly skilled Senior Specialist to join our team. As a key member of the Ascendis Pharma team, you will play a crucial role in drug product formulation development and establish a good collaboration with the CROs and CMOs used by Ascendis Pharma.

You will be part of Pharmaceutical Development consisting of 12 employees and will report to the director of CMC Drug Product Formulation Development who is based in Hellerup, Denmark. You will be based in Hellerup, Denmark.

Your Key Responsibilities:

Drug Product Formulation Development:

  • Developing and implementing strategies for the development of drug products and drug-device combination products.
  • Conducting and reporting pharmaceutical development studies including formulation development and stability studies to support all clinical phases.

Regulatory Compliance:

  • Ensuring compliance with external requirements, product quality, project timelines, and facilitating product transfer from CMC to Product Supply.
  • Writing regulatory documentation, supporting interactions with Health Authorities, and reporting project progress to management.

Qualifications and Skills:

You hold a relevant academic degree - preferably a Master or PhD in Pharmacy, engineering, chemistry, or equal field - and 7+ years in Biotechnology or Pharmaceutical Development with 3+ years of direct experience with injectable formulation development.

You are a strong team player, analytical, and have a can-do attitude. To succeed in the role, we expect you to possess strong scientific leadership skills with the ability to balance risks and timelines across Ascendis project pipeline, and proactively handle multiple tasks and challenges simultaneously.

You possess good communication and stakeholder management skills when representing the drug product team in cross-functional and cross-site teams and with CROs and CMOs. To thrive at Ascendis Pharma culture you possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

Travel: 15-25 days per year.



  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    About the DepartmentWe are a well-functioning department with many interfaces in the organization, including production, management, and other QA departments.Our team is dedicated to making a difference in the pharmaceutical industry and we are committed to creating an inclusive culture that celebrates the diversity of our employees, patients we serve, and...


  • Gentofte, Gentofte Kommune, Denmark Ascendis Pharma Full time

    About Ascendis PharmaAscendis Pharma is a fast-growing biopharmaceutical company dedicated to making a meaningful difference in patients' lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to develop new and potentially best-in-class therapies to address unmet medical needs.We are seeking an...

  • HVAC Specialist

    2 days ago


    Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Job Overview:Novo Nordisk A/S is seeking a skilled HVAC specialist to join our team in Denmark. As an HVAC Specialist, you will play a vital role in ensuring the optimal performance of our aseptic manufacturing environment.Key Responsibilities:Provide specialized HVAC support within the aseptic manufacturing environment, ensuring compliance with regulatory...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Metrology Specialist to join our team at Novo Nordisk A/S. As a key member of our technical department, you will play a crucial role in ensuring that our production equipment meets both internal and external metrology requirements.In this role, you will be responsible for handling metrology-related incidents,...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    At Ascendis Pharma A/S, we are seeking a highly skilled Senior Quality Assurance Specialist to join our QA team in Copenhagen. This role will be responsible for driving the quality oversight of our development projects and collaborating with global teams to ensure the delivery of best-in-class products.About UsWe are a dynamic biopharmaceutical company...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    OverviewAscendis Pharma A/S is a fast-growing biopharmaceutical company with operations in Denmark, Germany, and the United States. We are dedicated to developing innovative therapies to address unmet medical needs.Job DescriptionAs a Senior GCP Quality Assurance Specialist, you will play a critical role in ensuring compliance with Good Clinical Practice...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team in Aseptic Manufacturing. In this role, you will be responsible for ensuring products of the highest quality are released to the market.Key ResponsibilitiesSafeguard that analytical results are released in full compliance with current practices and guidelines from...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Join us at Novo Nordisk A/S as a Utility Process Development Lead and contribute to the development of technology standards for aseptic production lines worldwide. As a key member of the Fill & Finish Expansions department, you will be responsible for implementing global standards and best practices across multiple sites.About the RoleThe ideal candidate...


  • Gentofte, Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Novo Nordisk A/S is seeking a skilled Clean Utility Project Manager to develop technology standards for aseptic production lines worldwide. As a key player in the Fill & Finish Expansions department, you will be responsible for implementing global standards and best practices across multiple sites.About the RoleThe ideal candidate will have experience in...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    At Ascendis Pharma A/S, we are looking for a skilled Senior/Principal Statistical Programmer to join our dynamic team.Key ResponsibilitiesDevelop and execute programming strategies to support reporting of individual clinical studies, focusing on data integrity and collaboration.Contribute to multi-study analyses and fulfill regulatory requirements and...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    About the Role">Drive digital transformation and support rapid commercial expansion in Europe by ensuring delivery and ongoing operations of digital products and services.Align marketing campaign strategy, journey set-up, and defined campaign goals with business stakeholders.Manage outside agencies and partners to track and deliver targeted email and digital...


  • Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Ascendis Pharma A/S invites highly skilled professionals to contribute to the quality oversight of outsourced development activities in a dynamic environment.The company, powered by innovative TransCon technology, creates fully integrated biopharmaceutical enterprises dedicated to transforming patient lives. Guided by core principles of patients, science,...


  • Gentofte, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Company Overview">Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, the United States, UK, Italy, Spain, and France. The company applies its TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives.">Job Description">We are...


  • Gentofte, Gentofte Kommune, Denmark Best Talent Full time

    Company OverviewAscendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in 2007, is dedicated to addressing unmet medical needs. With their innovative platform technology, they aim to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Guided by their core values of patients,...


  • Gentofte, Denmark Novo Nordisk AS Full time

    Category: Engineering & Technical Are you a seasoned metrology professional with expertise in setting requirements for measuring processes and/or measuring equipment integrated in pharmaceutical production, validating measuring equipment, developing and maintaining documentation related to measurement processes and equipment? Do you thrive in a fast-paced...


  • Gentofte Kommune, Denmark Ascendis Pharma Full time

    Senior Specialist, CMC Drug Product Formulation Development Are you passionate about drug product formulation development? Do you have extensive experience in pharmaceutical development from Biotech or Pharmaceutical industry? If so, now is your chance to join Ascendis Pharma as our new senior specialist for CMC Drug Product Formulation Development. Ascendis...


  • Gentofte Kommune, Denmark Ascendis Pharma Full time

    Senior Specialist, CMC Drug Product Formulation Development Are you passionate about drug product formulation development? Do you have extensive experience in pharmaceutical development from Biotech or Pharmaceutical industry? If so, now is your chance to join Ascendis Pharma as our new senior specialist for CMC Drug Product Formulation Development. ...


  • Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...


  • Gentofte Kommune, Denmark Best Talent Full time

    The Company Ascendis Pharma A/S, a U.S. publicly held biopharmaceutical company founded in Copenhagen, Denmark in 2007, is committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by...


  • Gentofte, Denmark Novo Nordisk AS Full time

    Category: Engineering & Technical Are you experienced in the various aspects of aseptic production processes and thrive in close international collaboration and networking? If so, we are seeking a Project Manager to develop the technology standards required for the implementation of our new aseptic production lines worldwide at Novo Nordisk. Apply today...


  • Gentofte Kommune, Denmark Novo Nordisk AS Full time

    Jobbeskrivelse Placering Gentofte, Denmark Jobkategori Quality Ansøg nu Are you looking for a role that will enable you to use your strong quality mindset and great interpersonal skills to make a difference within Quality Assurance (QA)? Do you want to drive GMP (Good Manufacturing Practice) inspections to ensure the highest quality and safety of our...