Senior Drug Product Specialist, Zealand Pharma / 1830
Zealand Pharma A/S (Zealand) is a fast-growing Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicine and a highly attractive pipeline. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. They 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 was founded in 1998, Denmark and has presence in the US as well. See more at www.zealandpharma.com
Zealand´s employees are fundamental to their success, and they continue to be able to attract and retain people with experience and talent. They have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Do you really want to be empowered being part of and put your mark on the Drug Product Development? Encourage to take bold new decisions and work with ambitious deadlines? You will get highly rewarded for the absent of ego, focusing on teamwork and making brilliant results together with your team. If you can recognize yourself in this description, you might be the next Senior Drug Product Specialist to support the expanding portfolio and the continued global growth of Zealand.
The position is in the Department of Pharmaceutical Development, which is responsible for formulation development of peptide-based drug candidates and for collaboration with contract manufacture. Organizations for the manufacture of peptide-based drug substances and drug products under GMP. You will be joining an expanding team of 13 people including technologists, analytical scientists, drug product specialists, drug substance specialist, CMC-PM, CMC-Coordinator and HoD. They are not limited by their area of expertise and help each other where and when it is needed. They work very closely together both inter and intra departmentally - having the same goal and at the same time a lot of FUN. The department goal is to help a colleague succeed – They follow that every day.
The communication will be open, honest, and direct and one of the core values in the team is “your success equals success of the team and the project”.
Senior Drug Product Specialist
Do you want to be truly empowered?
- Biotech company with innovative peptide-based medicines
- Making a difference in people’s lives with metabolic & gastrointestinal diseases
- You want to excel and are a brilliant Drug Product Specialist
You will be involved in all early- stage development of Drug Products and combination products to and including phase 2. You will together with the team to ensure progress on development activities and create a fun, engaging and empowered working environment. You will have high influence on decisions as most of the power lies in the project.
You will be working in an international environment and have interfaces with many different disciplines working closely together with external partners and CMO’s.
Your responsibilities include:
- Responsible for DP development (Parentals) – including combination products
- Formulation development from research projects to development projects phase 2
- Responsible for design of DP manufacturing processes, including scale-up strategies
- Giving input to DP manufacturing plan(s), i.e. purpose, timing, and batch size
- Driving product risk assessment and process risk assessment in collaboration with CMO
- Driving scientific and strategic input to submissions/regulatory interactions in collaboration with Regulatory Affairs
At Zealand they understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary, and cross-cultural working environment characterized by strong teamwork, room for individual performance and development, informality and respect, high work-ethics, engagement, and fun.
Zealand is a growing organization, and you will be encouraged and welcomed to bring forth new ideas, discuss concerns and share feed-back with colleagues and management. You will report to Head of Department, Pharmaceutical Development
The ideal candidate holds a M.Sc./PhD degree in Life Science, within chemistry, biochemistry, pharmaceutical sciences, or another relevant fields and have at least 5+ years of experience from the Pharmaceutical industry.
The successful candidate will have the following profile:
- Experience with regulatory aspects of CMC work and GMP
- Experience with formulation development in early/late-stage stage projects in development of peptide based medicines (preferably parenterals)
- Experience with manufacturing of DP
- Experience with outsourcing of DP productions
- Experience with participating in cross functional project teams and well-developed collaboration skills
- Strong oral and written communication skills in English
- Ability to work in a dynamic environment and motivation for taking on new challenge
You have a proactive mindset and a desire to continuously develop and find innovative solutions. In addition, you are well-organized, and have the ability to plan, execute and meet deadlines. You see opportunities instead of difficulties.
You are motivated by having a high impact position and understand how to apply your cultural awareness to inspire trust and respect among your international colleagues. As an open-minded dedicated and flexible person, you utilise your high level of energy and can-do attitude to proactively handle the various tasks at hand.
Best Talent is responsible for the recruitment for this position at Zealand Pharma and review your application on a confidential basis. Forward your application including your CV attention ”1830/ Senior DP Specialist” by way of e-mail to email@example.com You can read more about Best Talent at www.besttalent.dk.