Senior CMC Specialist, Downstream Processing

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!

(Senior) CMC Specialist Downstream Processing
Do you want to work as One-team

Pioneering company with innovative and expansive growth strategy
Making a difference in peoples lives with future cancer treatments
You want to excel and are a skilled Downstream Processing Specialist

The Team
You will be part of the experienced Late-Stage Development (LSMD) team working with late-phase development activities of portfolio projects and preparation of the CMC package for regulatory filings in a stimulating international environment. You will join the Process team responsible for Upstream and Downstream processes currently consisting of 12 people and expanding.

Do you want to work as One-team Share knowledge be curious ask questions and learn new things to achieve goals and work with ambitious deadlines You will be rewarded by focusing on teamwork and making brilliant results through and with your team. If you can recognize yourself in this description you might be the next brilliant (Senior) CMC Specialist Downstream Processing to support the expanding portfolio and the continued global growth of Genmab.

The Role
As the (Senior) Downstream Processing (DSP) subject matter expert (SME) you will be responsible for DSP activities performed at Genmabs partnered CMOs and work across project teams to support the CMC Project Manager. You will also work closely with other SMEs such as those in upstream processing analytical validation and characterization. With great energy you will join Genmabs growth journey and contribute with your downstream experience.

The position is an onsite role in Copenhagen and you will report to the Associate Director Process Team Lead Head of Late-Stage Manufacturing Development CMC.

Responsibilities

• Late-stage development DSP strategies on ongoing projects
• Defining the scope for the late-stage DSP development activities together with our CMOs and partners according to the latest industry standards and regulatory guidance
• Oversight of the DSP activities performed at partnered CMOs such as troubleshooting process characterization and process performance qualification
• Preparing/reviewing technical documents including development tech transfer and process characterization reports and batch records
• Authoring and reviewing CMC regulatory submission documents
• Working closely with upstream processing SMEs to develop and align late-stage development strategies
• Supporting the definition and refinement of required processes for DSP activities

Requirements

• The ideal candidate holds a degree in Life Science within Chemistry Biochemistry Pharmaceutical Sciences or another relevant field and has at least 5 years of experience from the Downstream CMC area preferably from Late-Stage Development
• You have a thorough understanding and overview of downstream processes together with in-depth knowledge of downstream process characterization risk assessment and late-stage validation activities
• Preferably you have experience designing and evaluating DoE experiments and virus clearance study design and evaluation
• Experience in preparing and reviewing relevant filing documentation for regulatory market authorizations
• You have a proactive mindset and a desire to continuously develop and find innovative solutions
• In addition you are well-organized and can plan execute and meet deadlines. You have the ability to work successfully under pressure in a fast-paced environment with tight timelines
• As an open-minded dedicated and flexible person you utilize your high level of energy and can-do attitude to proactively handle the various tasks at hand.
• Strong communication skills are essential in this role which interacts with other disciplines and you are of course excellent in English both written and verbal
• As an open-minded dedicated and flexible person you utilize your high level of energy and can-do attitude to proactively handle the various tasks at hand
• Strong communication skills are essential in this role which interacts with other disciplines and you are of course excellent in English both written and verbal

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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