Downstream Specialist/Senior Specialist

Downstream Specialist/Senior Specialist

Ascendis Pharma

Hellerup, Denmark

Are you ready to take the lead in downstream process development? Do you thrive in a dynamic, science-driven, and collaborative environment? At Ascendis, you’ll have the opportunity to make a real impact.

We are looking for a passionate Downstream Specialist/Senior Specialist who takes on responsibility to join our growing team. In this role, you will be responsible for downstream process development and overseeing downstream manufacturing at CMOs. This is an exciting opportunity to work in a fast-paced, collaborative environment with global, cross-functional teams, all striving to achieve extraordinary results. You’ll be expected to take ownership, have room to grow, and make a meaningful impact on patients’ lives every day.

As part of the Biologics Development team, you’ll work closely with dedicated colleagues focused on biologics process development and manufacturing. Your team and manager, the Director of Biologics Development, will be based in Hellerup, while you collaborate with stakeholders across our Hellerup and Heidelberg sites, as well as with our CMOs.

Key Responsibilities

• Develop downstream processes and oversee GMP manufacturing at CMOs during clinical development;
• Support manufacturing process transfers, ensuring seamless execution;
• Review and approve development and GMP manufacturing documentation;
• Evaluate deviations and change controls from manufacturers;
• Facilitate communication and ensure alignment on project milestones;
• Participate in preparing work orders for process development activities at CMOs;
• Author and review regulatory submission documents.

Qualifications and skills

You hold a relevant academic degree – preferably a Master of Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or the like – and have more than 5 years of experience with downstream process development and GMP manufacture within the pharmaceutical industry. A candidate possessing a PhD is preferred but it is not a requirement. The successful applicant will have a record of accomplishments in delivering API manufactured according to GMP to deadline and on budget. You are proficient in written and spoken English at a professional level.

Furthermore, you have:

• A strong scientific background and hands-on experience in biologics downstream process development and GMP manufacturing for clinical or commercial use;
• An analytical mindset with a focus on data evaluation and interpretation;
• Familiarity with quality assurance and regulatory expectations in process development;
• Experience in outsourced process development and GMP manufacturing (preferred);
• Knowledge of process transfer and scale-up (preferred).

As a person, you are:

• Committed to delivering high-quality results and thorough in your work;
• Science-driven, proactive, and timely identify and resolve challenges;
• Independent yet highly collaborative, thriving in diverse teams;
• Focused on moving projects forward, willing to take on routine tasks when needed to meet deadlines;
• Adaptable and able to navigate changes in project plans (effectively).

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