Be the new
Device Design Control Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fully integrated biotechnology company leading in delivery of specialty medicines with the first New Drug Application in review with the FDA. 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 Pharma A/S (Zealand) is looking for an experienced Device Design Control Specialist to be in charge of device documentation for our development projects across the entire device portfolio.
As Device Design Control Specialist at Zealand you will have the overall responsibility for the development documentation of the device parts for all projects together with the responsibility for risk management processes and design of packaging material. You will work close together with the Device Development partners to ensure the documentation, the activities, and the project management at Zealand to ensure progress of the projects.
You will report to the Vice President of Device & Manufacturing Science and join a team of 10 highly experienced CMC/Device professionals, responsible for late-stage development and manufacturing activities. You will be working in cross-functional organization project together with other functions. Coordination and communication with CMOs is a key part of the job alongside internal Zealand collaboration
You will be part of an innovative and agile biotech company focused on the discovery, design, development and commercialization of innovative peptide-based medicines.
The successful candidate will be responsible for:
- Design Control documentation overall
- Experience with Design Control in accordance with EU ISO 13485, US 21CFR820 Quality Systems and preferably in relation to working with combination products
- Write design input documentation
- Review and approval of design output documentation from partners
- Contribute to the progress of Human Factors activities are planned, executed and documented together with the Human factor partner.
- Development of Instruction for use and packaging material for devices together with CMO and development partners.
- Risk management procecess including User risk assessments
- Planning and execution of device testing with CMO
The successful candidate will have:
What we offer
Zealand’s employees are one of the company’s most important assets, and we strive to attract, develop and retain the best talents, and to be a company where employees thrive.
At Zealand, we understand the value of a diverse workforce, and as an employee you will be part of an innovative cross-disciplinary and cross-cultural working environment. You will be involved in activities that are central to Zealand’s strategy of advancing an exciting product pipeline. You will work together with highly skilled and engaged colleagues in an both ambitious and fun athmosphere.
We offer a combined salary package including pension scheme and health insurance, as well as the option of joining the company lunch program, and use of massage, fitness and social facilities.
To find out more about working at Zealand, visit our careers site and view our company video at:
Please apply no later than August 12, 2020.
For further information, please contact Vice President of Device & Manufacturing Jakob Gjelstrup Kristensen
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development, and commercialization of next generation peptide-based medicines that change the lives of people living with metabolic and gastrointestinal diseases. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics.
Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.
- A relevant academic degree – preferably a Master of Science within Engineering, Chemistry, Biochemistry, Pharmaceutical sciences or similar
- At least 5 years experience from the Pharmaceutical Industry, working with device development.
- Excellent documentation skill and structured working style
- Good communication and collaboration skills
- Proficiency in English at a professional level, both written and spoken
- Passion about working in collaborative, complex and fast-paced environment with a high sense of urgency and with the ability to “walk the extra mile”