Be the new Senior Device Manufacturing specialist
In a biotech company bonding to discover, design and develop innovative peptide-based medicines
We are looking for a new talented Senior Device Manufacturing specialist, who has extensive Device manufacturing experience. Especially within manufacturing of prefilled pen systems and autoinjectors. If this sounds like you, and you are ready to take on a broad area of responsibilities with an independent attitude, you are a match for us.
You will join the dedicated and skilled Zealand Pharma Device Development team, reporting to the VP of Device Development. Your contributions will be pivotal in executing and documenting all device manufacturing activities.
The job includes extensive collaboration across the Zealand Pharma organization and includes close dialogue with our device development partners and contract manufacturing organizations. You will be a key contributor to making innovative drugs available to patients.
Responsibilities
The job will primarily focus on Design Transfer and Device Manufacturing activities, e.g.:
Execute the Design Transfer Plan, focusing on process and documentation requirements
Collaborate with CMOs on technical transfers and manufacturing changes
Define and implement manufacturing specifications, such as IPC and release criteria
Conduct process risk assessments to ensure manufacturing robustness
Support validation processes for assembly and packaging at CMOs
Develop inclusive packaging and labeling materials
Manage complaints and perform analysis of return samples to uphold quality standards
Collaboration regarding all disciplines of Design Control: Planning, Requirement management, development, design output, Design verification and Risk management.
Candidate Profile
Degree in Life Science, such as engineering, biochemistry, pharmaceutical sciences or related field
Experience in the medical device industry is essential, particularly in Design Control and device manufacturing development following ISO 13485 standard
Experience with GMP requirements according to FDA guidelines, process risk assessments, and at least 3 years of experience in Device manufacturing
Familiarity with other aspects of Design Control is advantageous, such as: Requirement management, design verification, device risk management or packaging development
As a person you are proactive and detail-oriented with expertise in device manufacturing—particularly with prefilled pens and autoinjectors. You thrive independently while collaborating closely with internal teams and external partners. With a strong focus on quality, compliance, and process robustness, you are motivated by the goal of bringing innovative drug delivery systems to a diverse range of patients.
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 August 10, or as soon as possible. The applications will be reviewed as they come in. For further information, please contact Lars Stenholt, VP Device Development, E-Mail: LStenholt@zealandpharma.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.
