Be the new (Senior) Drug Substance Specialist
In a biotech company bonding to discover, design and develop innovative peptide-based medicines
Are you energized by collaborative and fun teamwork, excels in handling complex tasks, enjoys continuous improvements and thrives with execution. 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.
Your responsibilities will include late-stage drug substance development, process validation and manufacturing execution as well as support in the commercial phase. Given our collaboration with Contract Development and Manufacturing Organizations (CDMO), effective coordination and collaboration with external partners is a significant aspect of this role.
In this role, you will be the professional anchor and expert in your field, and you will play a key role in driving the late-stage drug substance manufacturing strategy. You will be empowered to shape the direction and the role in general as well as how you execute it daily. Furthermore, you are not only empowered to but expected to executive decision-making and take ownership of your area.
You will be joining a newly formed team and will be working together with a range of experts within CMC area. Our culture is built on cross-functional teamwork, strong engagement, and a friendly, fun atmosphere where everyone’s contributions lead to shared success.
Responsibilities
- Responsibility for Drug Substance late-stage manufacturing, including scale-up and process validation within Development and Life Cycle Management projects.
- Key contact and coordinate manufacturing collaborations with DS CDMOs, ensuring effective day-to-day communication, adherence to oversight plans, and seamless transfer of technical knowledge.
- Actively support and optimize GMP manufacturing activities at CDMO sites, including review of production documentation and critical deviations to ensure compliance with high manufacturing standards.
- Serve as a key member of the CMC team by integrating manufacturing insights into project planning and execution, thereby driving progress toward regulatory approval and commercial success.
- Continuously seeking improvements in manufacturing operations and our internal processes.
- You will be a key player in building the team, internal workflows, standards and setting the direction of internal and external collaborations.
Candidate profile
The successful candidate will possess most or all of the following qualifications:
- A MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related field.
- A minimum of 3 years in the Pharmaceutical Industry with direct involvement in drug substance manufacturing operations.
- Proven experience in process upscaling and executing process validation (PPQ batches) of synthetic peptides within a manufacturing environment.
- Demonstrated success in outsourcing drug substance production and working collaboratively with CDMO manufacturing teams.
- Hands-on experience with Quality Risk Management (e.g., FMEA) as applied to drug substance manufacturing processes.
- In-depth knowledge of GMP manufacturing practices and regulatory requirements in late-stage drug substance development.
- A track record of effective participation in cross-functional teams with strong collaboration and communication skills.
- A proactive mindset with the willingness to take on new challenges and a commitment to driving continuous improvement in manufacturing processes.
- Excellent written and verbal communication skills in English.
- A friendly, collaborative, and results-oriented approach that aligns with our culture.
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 2th of March 2025 or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Head of Manufacturing, Rasmus Sandberg-Schaal at +45 3111 6287.
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. 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.
