Be the new
Senior Drug Product Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With two products on the market and three candidates in late-stage development, Zealand is a unique success story in Danish biotech. 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. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand is seeking a Senior Drug Product Specialist with a wish for participating in CMC submission coordination and cross departmental QMS coordination. The Drug Product Specialist will be involved in early to late-stage formulation/drug product development. The Drug Product Specialist will also participate in designing and implementing quality risk management in product development.
The position is in the department of Pharmaceutical Development, which today counts thirteen scientists and CMC PM’s and four technicians. The department is responsible for characterization of physiochemical properties, analytical development and formulation of peptide-based drug candidates as well as the collaboration with contract manufacture organizations for the manufacture of peptide-based drug substances and drug products under GMP for early to late-stage clinical development.
Job Profile
Responsibilities include helping us to:
- Coordinate IND / CTA input for CMC (including RA and CMC storyline)
- Ensure review process for CMC submission and Question/answer process
- Be responsible for coordination of Pharmaceutical Development SOP’s for interfaces and coherence
- Be responsible for DP development (Parentals or Oral delivery) – including combination product
- Overall be responsible for Product Risk Management plan and report, including coordination with CMOs
- Give input to DP production plan, i.e., purpose, timing, and batch size
- Review documentation from CMOs (CoA’s, specifications, deviations, changes)
- Ensure planning and oversight of manufacturing activities with CMO.
Candidate Profile
The successful candidate will have most or all the below qualifications:
- A MSc/PhD within chemistry, biochemistry, pharmaceutical sciences, or other relevant fields
- > 8 years experience from the Pharmaceutical Industry
- Extensive experience with regulatory aspects of late-stage CMC work and GMP
- Experience with formulation development in early/late-stage projects in development of peptide-based medicines (oral/parenterals)
- 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
- Great people and stakeholder management skills
- The ability and engagement to “walk the extra mile”
- The ability to work in a dynamic environment and the motivation for taking on new challenges.
What we offer
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.
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive 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 www.zealandpharma.com.
Application
Please apply no later than October 11, 2021.
For further information, please contact Mette Svendgaard
at +45 5060 3663 or MSvendgaard@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. Additionally, the portfolio includes clinical license collaboration 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.
