CMC Specialist, Drug Product

CMC Specialist, Drug Product

Genmab

Copenhagen, Denmark

In terms of Genmab’s expansive growth, we are now looking for a Drug Product Subject Matter Expert (SME) to support and optimize the area of In-use Stability and Compatibility for Genmab’s portfolio products. You will work closely together with early/late-stage project teams as well as Clinical Drug Supply, Clinical Trial Management and subject matter experts within different areas of our global CMC Manufacturing organization. As a Drug Product SME within In-use Stability and Compatibility, you will play a pivotal role in ensuring the integration of our pharmaceutical products within various healthcare environments. You will support the optimization of in-use activities to help patients receive life-changing therapies sooner. Leveraging your expertise in drug product formulation or clinical drug supply, you will assess compatibility with ancillaries and delivery systems, storage conditions, and patient needs.

You will be part of the experienced Late Stage Manufacturing Development (LSMD) department working with late-stage development activities of portfolio projects and preparation of the CMC (chemistry, manufacturing, and controls) package for regulatory filings in a stimulating international environment.

You will join the Pharmaceutical Development team, responsible for Drug Product (DP) late-stage development and validation activities currently consisting of 4 people and growing. With regards to In-use Stability and Compatibility, the Pharmaceutical Development team has the overall responsibility for the strategies for both early and late-stage development projects.

Responsibilities

• Responsible for/support to the oversight of strategies for In-use Stability and Compatibility for early/late-stage clinical development programs to ensure alignment with product objectives and regulatory requirements
• Drive optimization for In-use Stability and Compatibility studies conducted for Genmab portfolio projects, incl. preparing/reviewing protocols and reports
• Provide strategic data driven guidance to evaluation of ancillary requests from clinical sites/Clinical Drug Supply including risk assessments
• Optimize processes for In-use Stability and Compatibility studies and for evaluations of ancillary requests
• Oversight of new trends within materials used for preparation and administration of drug products in clinics
• Collaborate with cross-functional teams such as Medical and Clinical to integrate In-Use Compatibility considerations into product development plans, accelerating time to decision.
• Support authoring and reviewing relevant regulatory CMC documents for In-Use Compatibility
• Responsible for CMC input to clinical trial documents such as IMP (Investigational Medicinal Product)/Pharmacy manuals
• Support Drug Product late-stage development activities, incl. formulation development, drug product process characterization and validation activities
• Support Drug Product activities performed at our partnered CMOs

Requirements

• It is expected that you have a Master’s degree in natural science, pharmacy or similar
• You have 3-5 years of documented professional experience with CMC development of biological products in the Biopharmaceutical industry
• You have active experience within drug product formulation incl. in-use Stability and Compatibility studies and/or experience within clinical drug supply and a good understanding of regulatory requirements
• Experience with multiple delivery systems is a plus, but not a requirement
• Excellent communication skills in English written and oral
• Experience with scripting and programming for optimization in tools such Python is advantageous
• Experience with statistical software such as SAS JMP will also be a benefit
• You take initiative and responsibility
• Well-organized, with the ability to plan, execute, and meet deadlines
• You are a team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

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