BE THE NEW

(Senior) Drug Substance Specialist

in a biotech company focused on the discovery, design and development of innovative peptide-based medicines

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning. If this sounds like you, and you are ready to embrace a broad range of responsibilities with an independent mindset, then you are the perfect fit for us.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Given our collaboration with Contract Development and Manufacturing Organizations (CDMO), effective coordination with external partners is a significant aspect of this role.
In this role, you will be the professional anchor and expert in your field, and you will play a key role in driving the late-stage drug substance strategy. You will be empowered to shape the direction and the role generally as well as how you execute it daily. Furthermore, you are not only empowered to, but expected to executive decision-making and take ownership of your area.

You will be joining a highly experienced team consisting of experts within CMC, Manufacturing and Submission. We value a friendly, helpful, and fun atmosphere where we obtain great results together.

Responsibilities

Overall responsibility for Drug Substance late-stage development, up-scale and process validation in Development and Life Cycle Management projects
Manage the collaboration with DS CDMO (follow up on oversight plans and day-to-day communication, and securing transfer of knowledge)
Support technical and GMP manufacturing activities at CDMO, including review of documentation (batch records, FMEA risk assessments, reports etc.)
Active contribution in CMC team, working collaboratively on project progress towards regulatory approval
Driving scientific and strategic input to submissions/regulatory interactions in collaboration with Regulatory Affairs and CDMO

Candidate profile

The successful candidate will possess most or all of the following qualifications:

A M.Sc/PhD within chemistry, biochemistry, pharmaceutical sciences, or another relevant field
+3 years experience from the Pharmaceutical Industry
Experience with process upscaling and process validation (PPQ batches) of synthetic peptides
Experience with outsourcing of drug substance production and working with CDMO’s
Experience with Quality Risk Management (FMEA) on DS
Experience with GMP and regulatory aspects of late-stage CMC work/developmentExperience with participating in cross functional project teams and well-developed collaboration skills
Strong written and verbal communication skills in English
The ability and engagement to “walk the extra mile” and taking on new challenges
Friendly and collaborative mindset

Bonding to innovate 

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.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.

We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.

We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.

The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.

Let’s bond and be bold 

We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/

Interested? Please apply no later than May 29, 2024, or as soon as possible. The applications will be reviewed as they come in.

For further information, please contact Britt Gren Sjøholm at +45 50603849 or BSjoholm@zealandpharma.com

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having 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 bond with us through LinkedIn or Twitter @ZealandPharma.