Scientist, CMC Drug Product Development

Are you passionate about drug product development? Do you have formulation or production experience within Biotech or Pharmaceutical industry?

If so, now is your chance to join Ascendis Pharma as our new Scientist for injectable formulations with-in CMC Drug Product

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on 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 fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate scientist to join our growing team. As member of the pharmaceutical development team, you will play an important role in getting our development pipeline projects from early-stage development through to commercialization. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional teams working together to achieve extraordinary results.

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

If you are early in your career, we will support your growth and development of formulation-specialist and technical project management skills.

Your key responsibilities will be:

• Participation in activities regarding formulation, aseptic manufacturing and sterile Fill-Finish activities during development and process validation.
• Designing, executing, and reporting pharmaceutical development studies.
• Planning, executing, and reviewing drug product manufacturing campaigns together with CMOs and the project team (including QA).
• Participation in project meeting and processes with our Contract Manufacturers (CMOs).
• Facilitate internal transfer of product from CMC to Product Supply.
• Writing regulatory quality documentation and support interactions with Health Authorities.

Qualifications and Skills:
You hold a relevant academic degree – preferably a Master or PhD in Pharmacy, engineering, chemistry, or equal field – and 3-5 years in Biotechnology or Pharmaceutical Development preferably with direct experience with-in Injectable Formulation, production and Validation.

Furthermore, you have:

• Knowledge of cGMP requirements, regulations, and guidelines.
• Experience in formulation and/or process development and documentation, including regulatory and quality aspects of drug development projects.

Key competencies:
You are a strong team player, analytical, and have a can-do attitude.

To succeed in the role, you must be persistent, pay a high level of attention to details and be goal orientated.

As a person you bring energy and a positive mindset, and you enjoy being part of a team with many and varied tasks and functions. You will join a skilled and helpful team in an exciting environment with great flexibility.

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: 10-15 days per year.

Office: Denmark, Hellerup, Tuborg Boulevard 12

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 company, please visit our website www.ascendispharma.com

Benefits

• You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
• Laptop, iPhone, paid internet, and home office equipment
• A thorough and structured onboarding program
• To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.
• Soft drinks, fresh fruit, and lunch every day in our canteen.
• Ascendis Pharma headquarters resides in a modern and bright office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
• To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.

Hellerup