Offer information

Senior Subject Matter Expert, Drug Product (Copenhagen, Denmark)

Agenzia Piemonte Lavoro - Eures

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Description

JOB DESCRIPTION 

EURES Agenzia Piemonte Lavoro is looking for a Senior Drug Product Subject Matter Expert (SME). Leveraging your expertise in drug product formulation, you will assess compatibility with delivery systems, storage conditions, and patient needs. You will be joining the “Pharmaceutical Development and Product Support” team in the Late Stage Manufacturing Development (LSMD) department in CMC operations. LSMD currently has 25 team members and is responsible for the late stage development activities of Genmab’s portfolio projects and preparation of the CMC package for regulatory filings. Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. 

Key responsibilities include 

• Oversight of Compatibility and In-use strategies for early/late stage clinical development programs to ensure alignment with product objectives and regulatory requirements 

• Responsible for Compatibility and In-use studies conducted for Genmab portfolio projects, incl. preparing/reviewing protocols and reports 

• Responsible for providing expert guidance and recommendations for Compatibility and In-use inquiries (in-side/out-side Genmab) 

• Collaborate with cross-functional teams as Medical and Clinical to integrate Compatibility and In-use considerations into product development plans 

• Support authoring and review of relevant CMC regulatory submissions documents for Compatibility and In-use 

• Responsible for CMC input to clinical trial documents such as IMP/Pharmacy manual 

• Support DP late stage development activities, incl. formulation development, drug product process characterization and validation activities 

• Support DP activities performed at our partnered CMOs 

Requirements 

• Master’s degree in natural science, pharmacy or similar 

• You have at least 5-10 years of documented professional experience with chemistry, manufacturing, and controls (CMC) biologics product development in the Biopharmaceutical industry 

• You have active experience within drug product formulation, Compatibility and In-use studies and a solid understanding of regulatory requirements 

• Experience with multiple delivery systems is a plus 

• You preferably have experience with lifecycle management and medical information requests 

• Excellent communication skills in English written and oral. 

Moreover, you meet the following professional requirements: 

• You are focused on achieving goals that are important for the team and our organization 

• You have the ability to work successfully under pressure in a fast-paced environment and with tight timelines 

• You are pro-active, take initiative and responsibility 

• You are a team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders 

• With your positive attitude, you enjoy working in multicultural teams inside and outside of Genmab 

PLACE OF WORK: This role is located in Copenhagen, Denmark. 

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. 

WORK CONDITIONS: 

Full time. Salary is according to collective agreement in Denmark and negotiated on basis of experience and qualification. 

HOW TO APPLY: 

If you are interested in this position, please e-mail your CV & Cover Letter in English to eures.recruiting@agenziapiemontelavoro.it