We are currently seeking a dynamic Senior Drug Product Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning. If this sounds like you, and you are ready to embrace a broad range of responsibilities with an independent mindset, then you are the perfect fit for us.
BE THE NEW
Senior Drug Product Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
As a crucial member of the highly experienced CMC, Manufacturing, and Submission team, you will play a key role in late-stage development and manufacturing, life cycle management activities, and submission management.
Your responsibilities will include Drug Product development for late-stage projects and process and product support for commercial drug products. Given our collaboration with Contract Development and Manufacturing Organizations (CDMO), effective coordination with external partners is a significant aspect of this role, along with close collaboration with internal colleagues and external business partners.
- Overall responsibility 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 in collaboration with CDMO.
- Conduct process and product evaluations, maintenance, and oversight on LCM projects.
- Write scientific reports and documentation meeting requirements for pharmaceutical products.
- Ensure scientific writing of regulatory documents (NDA/MAA) leading up to achieving marketing authorization.
- Facilitate knowledge transfer to and support technical and GMP manufacturing activities at CDMO.
- Actively contribute to a CMC team, working collaboratively on project progress towards regulatory approval.
The successful candidate will possess most or all of the following qualifications:
Bonding to innovate
- A Life Science degree in chemistry, biochemistry, pharmaceutical sciences, or another relevant field.
- Minimum of 5 years' experience in the Pharmaceutical Industry.
- Extensive experience with GMP and regulatory aspects of late-stage CMC work/development.
- Experience with outsourcing DP productions and working with CDMO.
- Familiarity with drug development processes (preferably parenterals) and participation in cross-functional project teams.
- Strong written and verbal communication skills in English.
- Collaborative and structured nature.
- The ability and commitment to go the extra mile.
- Interest in working in a dynamic environment and taking on new challenges.
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.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than January 7, 2024, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Britt Gren Sjøholm at +45 50603849
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having 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 bond with us through LinkedIn or Twitter @ZealandPharma.