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Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Senior Project Manager/Process Specialist - Drug Substance Manufacturing

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeHellerup, DenmarkNo salary listedIn-person

About the Job

Requirements

  • A relevant academic degree is required; a Master of Science or Ph.D. in organic chemistry, peptide synthesis, chemical engineering, or an equivalent field is preferred.
  • At least five years of experience in the pharmaceutical development or manufacturing industry is required.
  • Relevant hands-on experience in laboratory, pilot, or manufacturing facilities is required.
  • Good Manufacturing Practice (GMP) experience is required.
  • Professional proficiency in English is required.
  • Microsoft Office skills, including experience with SAS JMP or other data management tools, are required.
  • Strong teamwork and attention to detail are expected.
  • An entrepreneurial mindset and ability to work in an informal, open environment where innovation and change are key are expected.
  • Motivation to take on challenges and work collaboratively is expected.
  • Strong interpersonal skills and ability to establish and maintain productive collaboration with contract manufacturing organizations are required.
  • A proven ability to communicate with stakeholders across functions and disciplines is required.

Responsibilities

  • Manage and coordinate outsourced commercial manufacture of peptides, chemical starting materials, intermediates, and active pharmaceutical ingredients, including technology transfer, process validation (PPQ), post-PPQ optimizations, risk management, control strategies, and continuous process verification programs (CPV).
  • Troubleshoot with contract manufacturing organizations, including deviation and change management as a subject matter expert.
  • Support master batch record updates and batch release in collaboration with Quality Assurance.
  • Write and support regulatory submissions for marketing approval and post-approval.

About the Company

Ascendis Pharma

Biopharmaceutical company developing long-acting prodrugs

Ascendis Pharma uses its TransCon technology to create long-acting prodrugs for rare endocrine diseases, with expansions into oncology and ophthalmology. The platform temporarily attaches an unmodified drug to an inert carrier and releases the active drug in a predictable, sustained way after injection, reducing how often patients must dosing. It differentiates itself through a proprietary delivery system and a track record that includes marketed therapies like SKYTROFA for pediatric growth hormone deficiency and YORVIPATH for hypoparathyroidism, along with collaborations such as a Novo Nordisk deal. The company aims to improve patient outcomes by enabling easier, less frequent dosing while expanding its pipeline across rare endocrine diseases, cancer, and eye diseases.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Gentofte Municipality, Denmark
Founded
2007

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