Be the new
Assembly and Packaging Tech Transfer Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is looking for an experienced Assembly and Packaging Tech Transfer Specialist to be in charge of technical transfer of device assembly and packaging processes from development projects into our Contract Manufacturing Organisations (CMOs).
As Assembly and Packaging Tech Transfer Specialist at Zealand you will have the overall responsibility for the transfer process for all projects along with the responsibilty for handling manufacturing going forward. You will work closely with the CMOs and the device people at Zealand to ensure that knowledge, processes and documentation is transferred with a good process. After transfer you will continue to ensure manufacturing activities, handle manufacturing oversight and problem solving together with the CMOs. You will also be our specialist within Six Sigma and statistical process controls.
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 & manufacturing activities and commercial manufacturing. You will be working in cross functional organization projects or product teams 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.
Job Profile
The successful candidate will be responsible for assembly and packaging tech transfer and manufacturing activities for drug delivery devices:
- Lead responsible for device transfer activities related to assembly and secondary packaging processes to CMOs
- Act as a manufacturing expert representative during the device development stage within assembly processes and packaging design process
- Own the Tech Transfer project schedule and integrate this with the overall project plans
- Write and approve transfer documentation for the process
- Ensure knowledge transfer and anchoring
- Implementation and approval of new assembly and packaging equipment at the CMOs as needed
- Oversight of manufacturing activities at the CMOs both for development and commercial phase
- Ensure statistical process controls (SPC)
- Preferable act as specialist for six sigma and SPC
- Cultivate relationships and ensure timely coordination and communication with CMOs on manufacturing activities and issue handling
Candidate Profile
The successful candidate will have:
- 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, preferably within Assembly and Packaing Manufacturing
- Strong communication and collaboration skills (preferably collaboration with CMOs)
- Experience with six sigma and statistical process control
- Strong project management skills.
- Proficiency in English at a professional level, both written and spoken
- Passionate about working in collaborative, complex and fast-paced environment with a high sense of urgency and with the ability to “walk the extra mile”
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.
www.zealandpharma.com/zealand-as-a-work-place/
www.zealandpharma.com/video-about-zealand-new/
Application
Please send your resume/CV and cover letter no later than March 30, 2020.
For further information please contact Vice President of Device & Manufacturing Science Jakob G. Kristensen at jgk@zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have 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. Zealand’s portfolio also includes two clinical license collaborations 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 follow Zealand on LinkedIn or Twitter @ZealandPharma.
