(Senior) Project Manager/Process Specialist, Drug Substance Manufacturing

Ascendis Pharma; Gentofte Kommune; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Ascendis Pharma, headquartered in Hellerup, Denmark, seeks a Senior Project Manager or Process Specialist to lead outsourced commercial manufacture of peptides, starting materials, intermediates and APIs. The role includes tech transfer, PPQ, CPV, and collaboration with CMOs in a fast-paced, cross-functional environment.

You will drive process development, verification, and regulatory support, reporting to the Senior Director of Chemical Manufacturing.

Qualifications

• Master of Science or Ph.D. in organic chemistry, peptide synthesis, chemical engineering or equivalent; at least 5 years in pharmaceutical development or manufacturing.
• GMP experience required.
• Proficient English. MS Office skills including SAS JMP or other data management tools.
• Experience with technology transfer, PPQ, deviations or change management is a plus.

Responsibilities

• Manage outsourced commercial manufacture of peptides, starting materials, intermediates and APIs including tech transfer, PPQ, post-PPQ optimizations, risk management, control strategies and CPV.
• Troubleshooting with CMOs including deviation and change management.
• Support master batch record updates and batch releases with QA.
• Write and support regulatory submissions for marketing approval and post-approval.

Skills

Project management

Team collaboration

English proficiency

Analytical thinking

Quality mindset

Education

MSc or PhD in organic chemistry / peptide synthesis / chemical engineering

Tools

SAS JMP

MS Office

Job description

Do you have experience with outsourced chemical manufacturing of starting materials, intermediates and APIs? Are you passionate about science-driven development and manufacturing support in collaboration with contract manufacturing organizations (CMOs)?

If so, now is your chance to join Ascendis Pharma as our new (Senior) Project Manager or Process Specialist.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a skilled project manager/specialist to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in our team for commercial chemical manufacturing for projects having reached the stage of process qualification and commercial manufacturing. The manufacturing processes comprise peptide synthesis, peptide conjugation and purification and classic organic chemistry for small molecules and polymers. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the Chemical Manufacturing team consisting of 6 colleagues, and report directly to Birgitte M. Malle, Senior Directorwho is based in Hellerup. You will be based in Hellerup.

Your key responsibilities will be:

• Manage and coordinate outsourced commercial manufacture of peptides, chemical starting materials, intermediates and APIs including technology transfer, process validation (PPQ), post PPQ optimizations, risk management, control strategies and continuous process verification programs (CPV)
• Trouble shooting in collaboration with CMO’s including Deviation and Change management as subject matter expert
• Support master batch record update and release of batches together with QA
• Write and support regulatory submissions for marketing approval and post-approval

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master of Science or a Ph.D. in organic chemistry, peptide synthesis, chemical engineering or equivalent – and have at least 5 years of experience within pharmaceutical development or manufacturing industry.

Furthermore, you have:

• Relevant hands-on experience from laboratory, pilot and/or manufacturing facilities
• GMP experience
• Proficient English professional skills
• MS Office skills including experience with SAS JMP or other data management tools

Key competencies:

You are a strong team player, have attention to details, 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 also expect you to be a highly motivated individual who enjoys being challenged and working in collaborative environments. Strong interpersonal skills are necessary as your job is to establish and maintain good and productive collaboration with CMO’s. A proven ability to communicate with stakeholders of other functions and disciplines is crucial.

Travel: up to 10-15 days per year.

Office: Tuborg Boulevard 12, 2900 Hellerup, Denmark

For more details about the position or the company, please contact Senior Director for Chemical Manufacturing, Birgitte M. Malle, [e-mail]

You can learn more about Ascendis by visiting our website www.ascendispharma.com