Be the new
Senior Drug Substance Specialist
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) aims to become a fully integrated biotechnology company leading in delivery of specialty medicines. 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.
As our new Senior Drug Substance Specialist you will primarily be involved in late stage Drug Substance development (synthetic peptides) as well as participating in research/early stage projects with focus on drug substance production.
The position is in the Department of Pharmaceutical Development, which today counts eleven scientists, four technicians and a student assistant. 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. The department has moved into late stage development of several projects, so this is a unique chance to join the journey!
The successful candidate will be:
Managing the collaboration with drug substance CMO
Following up on oversight plans and day-to-day communication, and securing transfer of knowledge
Primarily involved in late stage drug substance development (PPQ activities and Risk Management)
Contributing to risk assessments and CQA development at the CMO
Reviewing documentation from CMOs (batch records, risk assessments, reports etc.)
Participating in cross functional CMC team
Participating in research/early stage project
Driving scientific and strategic input to submissions/regulatory interactions in collaboration with Regulatory Affairs.
The successful candidate will have:
An M.Sc./Ph.D. within chemistry, biochemistry, pharmaceutical sciences, or another relevant field
>10 years' experience from the pharmaceutical industry
Experience with outsourcing of drug substance production at drug substance CMOs
Extensive experience with solid phase peptide synthesis and input to process optimization
Experience with Quality Risk Management on drug substance
Experience with regulatory aspects of late stage CMC work and GMP
Experience with participating in cross functional project teams and well developed collaboration skills
Knowledge of lean six sigma in process design/optimization
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 motivation for taking on new challenges.
What we offer
Zealand’s employees are one of the company’s most important assets. We strive to attract, develop and retain the best talents, and to be a company where every employee can thrive.
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 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 November 20, 2019.
Position available with start January 1, 2020.
For further information, please contact Vice President of Pharmaceutical Development, Mette Svendgaard
at +45 5060 3663.
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
or follow Zealand on LinkedIn or Twitter @ZealandPharma.