Be the new (Senior) Drug Product Specialist
Are you energized by collaborative teamwork, handling complex manufacturing challenges, and passionate about continuous improvements and enjoy execution. Do you thrive in an environment where you can shape strategies and take ownership of your work? If so, we invite you to join our dynamic team as our new (Senior) Drug Product Specialist.
You’ll play a key role in driving our late-stage drug product manufacturing strategy—from technical transfer and scale-up to process validation and commercial production. You will also coordinate closely with external partners and Contract Development and Manufacturing Organizations (CDMOs), ensuring smooth communication and efficient execution of manufacturing projects.
In this role, you will serve as the professional anchor and expert in your field, and you will play a key role in driving the late-stage drug product manufacturing strategy. You will be empowered to shape the direction and the role generally 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 product late-stage manufacturing, including participation in technical transfer, scale-up, and process validation within Development and Life Cycle Management projects.
- Oversee and coordinate manufacturing collaborations with DP CDMOs, ensuring effective day-to-day communication, adherence to oversight plans, and the 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, 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’ experience in the Pharmaceutical Industry with direct involvement in drug product manufacturing operations.
- Proven experience in process upscaling and executing process validation (including PPQ batches) for drug products.
- Demonstrated success in managing outsourced drug product manufacturing and working collaboratively with CDMO manufacturing teams.
- Hands-on experience with Quality Risk Management (e.g., FMEA) as applied to drug product manufacturing processes.
- In-depth knowledge of GMP manufacturing practices and regulatory requirements in late-stage CMC development.
- A track record of effective participation in cross-functional teams with strong collaboration and communication skills.
- A proactive mindset with a willingness to embrace new challenges and drive 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.
Bonding to innovate
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 March 2, 2024, or as soon as possible. The applications will be reviewed as they come in.
For further information, please do not hesitate to 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.
