id: NDkwNTE1NyA3

reference: 4905157

documentId: 4905157

connectionPointId: 7

lastModificationDate: 1542197767556

stillingsbetegnelse: Drug Product Specialist

jobbeskrivelse:

Zealand Pharma A/S (Zealand) is seeking a Drug Product Specialist who will be responsible for the overall Drug Product development for a late stage development project.

You will be part of an innovative and agile Biotech company focused on the discovery, design and development of innovative peptide-based medicines. The Commercial Manufacturing department is responsible for late-stage development and manufacturing and you will be working in a focused project team together with other functions.

Since Zealand Pharma A/S is using Contract Development and Manufacturing Organizations, coordination with external partners is a major part of the job together with coordination of internal laboratory activities.

Job Profile

The successful candidate will: 

Be overall responsible for Drug Product development 

Drive process design and QbD activities on the project for the Drug Product process in collaboration with Contract Manufacturing Organizations 

Plan and execute PPQ activities in collaboration with Contract Manufacturing Organizations 

Ensure documentation for development is sufficient for NDA approval  Ensure knowledge transfer and support clinical manufacturing activities at Contract Manufacturing Organizations 

Actively be part of a CMC team and work together on project progress towards NDA approval.

 

Candidate Profile

The successful candidate will have: 

A MSc/PhD within chemistry, biochemistry, pharmaceutical sciences, or another relevant field 

> 5 years’ experience from the Pharmaceutical Industry 

Extensive experience with regulatory aspects of late stage CMC work and GMP 

Experience with late stage development of peptide based medicines (preferably parenterals) 

Experience with outsourcing of API and/or 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 motivation for taking on new challenges

 

Please send your application and CV no later than November 28, 2018 to: career (at) zealandpharma.com or Zealand Pharma A/S Att.: HR Smedeland 36 DK-2600 Glostrup For further information, please contact Vice President, Commercial Manufacturing, Jakob Gjelstrup Kristensen at +45 5060 3772 or jgk (at) 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.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit http://www.zealandpharma.com or follow Zealand on LinkedIn or Twitter (at) ZealandPharma.  .

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:

http://www.zealandpharma.com/zealand-as-a-work-place/

http://www.zealandpharma.com/video-about-zealand-new/

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C3322

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: ZEALAND PHARMA A/S

source: DK-STAR