CMC Specialist, Stability

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

At Genmab we are dedicated to transforming the lives of patients through innovative antibody-based medicines. To support our biologics pipeline and portfolio we are looking for a CMC Stability Specialist in the CMC Stability team to strengthen our CMC organization.

The Role

As a CMC Stability Specialist you will be part of the CMC Stability team organized within the CMC area. Additionally you will be part of and collaborate with CMC project teams.

You will join a small team of skilled and dedicated employees. The team supports the Genmab portfolio from early CMC development to commercial products.

In this role you will have responsibility for the stability governance of Genmab products. You will collaborate closely with colleagues in the team across CMC Quality Regulatory Affairs Drug Supply and with external partners at CMOs in a highly matrixed international environment.

This position will report to the CMC Stability Team Lead.

Key Responsibilities

• Act as stability subject matter expert supporting Genmabs biologics pipeline

• Ensure alignment and oversight of stability activities performed at external partners CMOs and internal laboratories

• Ensure scientifically sound and regulatory-compliant stability approaches aligned with ICH guidelines and regulations

• Perform and oversee statistical evaluation of stability data including trend analysis and shelf-life determination

• Author and review CMC sections of regulatory submissions (IND CTA BLA/MAA variations)

• Support health authority interactions and responses related to stability

• Be part of setting up the life cycle management of stability support for commercial products practices

Qualifications and Experience

• PhD or MSc in pharmaceutical sciences chemistry biochemistry statistics or related discipline

• Significant experience (typically 5 years) within CMC stability for biologics

• Extensive knowledge and understanding of stability testing for products in clinical development and/or marketed Biologics according to current market and best industrial practices

• Demonstrated knowledge and interested in statistical methods applied to stability data (e.g. regression analysis pooling trend analysis)

• Strong knowledge of ICH guidelines including Q1AQ1E Q5C and Q6B

• Experience with supporting global regulatory submissions

• Ability to translate complex scientific and statistical data into clear regulatory and business recommendations

Moreover you meet the following personal requirements

• You can work successfully and with integrity in a fast-paced environment with tight timeliness

• You are a Team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programs

• You have a structured and analytical approach when solving problems

• Flair for IT and user software to monitor stability

• You can manage multiple tasks prioritize work and define steps needed to achieve project and team goals

What You Can Expect at Genmab

• A high-impact role in a science-driven organization focused on patients

• A collaborative and inclusive culture with strong cross-functional teamwork

• Opportunities to shape strategy and contribute to key development decisions

• Professional growth in a global biologics company with a strong pipeline

Genmab will for the successful application offer an exciting position where the right candidate will have the opportunity to work with highly specialized people across functions in an informal multicultural environment.

If this advertisement has caught your attention and you think you are a match dont hesitate to apply for this position. We screen candidates on an ongoing bases and call in for interviews accordingly.

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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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