Be the new
Drug Substance 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.
As our new 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 substancemanufacturing.
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 and development 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:
The successful candidate will have:
- Overall responsible for DS development plan in project
- Primary contact person to DS CMO and coordinate planning and follow up on productions
- Contributing to risk assesments and CQA development at the CMO
- Reviewing documentation from CMO’s (batch records, risk assessments, reports etc.)
- Participating in cross functional CMC teams
- Participating in late stage as well as research/early stage project.
- Driving scientific and strategic input to submissions/regulatory interactions in collaboration with Regulatory Affairs
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:
- A M.Sc/PhD within chemistry, biochemistry, pharmaceutical sciences, or another relevant field.
- 3-5 years experience from the pharmaceutical industry or relevant.
- Experience with outsourcing of drug substance production at drug substance CMO’s
- Experience with solid phase peptide synthesis and input to process optimization
- Experience with regulatory aspects of CMC work and GMP
- 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”
- Ability to work in a dynamic environment and motivation for taking on new challenges
Please send your cover letter/CV no later than August 16, 2020.
For further information, please contact Vice President of Pharmaceutical Development Mette Svendgaard at +45 5060 email@example.com eller Senior Drug Substance Manager Leila Malik at +45 5060 3764/ firstname.lastname@example.org.
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.