Be the new
Senior Drug Product Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well.
Zealand Pharma A/S (Zealand) is looking for a Senior Drug Product Specialist who is energized by working in close collaboration in teams on complex tasks with lots of fun and learnings.
You will be part of the very experienced CMC, Manufacturing and Submission team who is responsible for late-stage development and manufacturing, life cycle management activities and submission management.
You will be responsible for the overall Drug Product development for late stage development projects as well as process and product support for commercial drug products. Since Zealand Pharma A/S is using Contract Development and Manufacturing Organizations (CDMO), coordination with external partners is a major part of the job together with collaboration with internal colleagues and external business partners.
- Overall responsible for Drug Product development in late stage Development and Life Cycle Management projects
- Plan and execute DP process design, Design of Experiments, QbD activities and PPQ activities on development project in collaboration with CDMO
- Process and product evaluations, maintenance and oversight on LCM project
- Write scientific reports and documentation meeting requirements for pharmaceutical products
- Ensure scientific writing of regulatory documents (NDA/MAA) leading up to achieving marketing authorization.
- Ensure knowledge transfer to and support technical and GMP manufacturing activities at CDMO
- Actively be part of a CMC team and work together on project progress towards regulatory approval
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit www.zealandpharma.com.
Please apply no later than 7 October 2022.
For further information, please contact Britt Gren Sjøholm at +45 50603849
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.
- A Life Science degree within chemistry, biochemistry, pharmaceutical sciences, or another relevant field.
- At least 5 years’ experience from the Pharmaceutical Industry
- Extensive experience with GMP and regulatory aspects of late stage CMC work/development
- Experience with outsourcing of DP productions and working with CDMO
- Experience with drug development processes (preferably parenterals) and participating in cross-functional project teams
- Strong written and verbal communication skills in English
- Collaborative and structured nature
- The ability and engagement to “walk the extra mile”
- Interest in working in a dynamic environment and taking on new challenges