Analytical Life Cycle Management (LCM) Senior Specialist

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!

The Role

At Genmab were committed to transforming the lives of people with cancer through innovative antibody therapeutics. As part of our continued growth we are looking for a Life Cycle Management (LCM) Senior Specialist in the CMC Analytical & Characterization Department within CMC MSAT in CMC Development & Manufacturing / Technical Operations. In this role you will contribute to our antibody-based modalities LCM projects including e.g. Bispecific Antibodies and Antibody-Drug Conjugates (ADCs).

You will join a highly specialized CMC Analytical and Protein Characterization department working as a Subject Matter Expert in an international collaborative and matrix environment.

You will partner closely with:

• CMC LCM Project Managers.

• CMC MSAT colleagues across CMC Process Development CMC Stability CMC Pharmaceutical Development and CMC Writing.

• Cross-functional stakeholders in Quality (QA) Regulatory CMC Product Development (our non-GMP CMC development lab in Utrecht NL) and Genmab QC (Ballerup DK).

• External partners including Contract Manufacturing Organizations (CMOs) in a network across the globe.

Your work will be central to ensuring robust analytical overview enabling successful support to regulatory submissions (BLA/MAA) post approval activities and lifecycle management and to ensure smooth transition from development to commercial LCM. At Genmab collaboration scientific excellence and accountability are at the heart of everything we do - and your contributions will directly support our mission to bring impactful therapies to patients.

Key responsibilities

• Lead and maintain lifecycle managementactivities including analytical method qualification validation transfer and maintaining specifications.

• Scientific and technical oversight of analytical activities at CMOs including evaluation of quality events.

• Support analytical activities related to process changes and site transfers.

• Author and reviewtechnical and regulatory documentation including analytical CMC section for submissions responses to health authority questions and documentation supporting post approval changes.

• Act as atrusted subject matter expert guiding analytical approaches from late development through commercialization.

• Drive theimplementation of analytical strategiesacross projects.

• Collaborate closely with CMC MSAT colleagues regulatory CMC QA project managers and Genmab QC to align and progress activities for the late development and commercial projects.

• Work cross-functionally to develop and strengthenLCM strategies and processes.

Requirements

• Masters degree in Science Pharmacy or a related field (PhD or additional qualifications are an advantage).

• 7 years of experiencewithin CMC or a related area in the pharmaceutical or biotechnology industry.

• Strong expertise inand experience with analytical LCM e.g. including experience from QC.

• Experience working with and biologics preferably from Antibodies and Antibody Drug Conjugate projects.

• Experience with authoring and reviewingregulatory documentation and submissions(e.g. BLA MAA) and responses to health authorities.

• Experience working with CMOs and external partners in a late stage or LCM setting.

• Excellent communication skills in English with the ability to engage effectively across functions and cultures.

• Preferred knowledge with characterization and reference standards.

The proposed gross annual base salary range for this position in the primary location based on a full time schedule is:

The final salary offer will depend on several factors including your skills qualifications and experience.

In addition to base salary this position is eligible to additional forms of compensation such as discretionary bonuses and long-term incentives.

When you join Genmab you become a part of a culture that supports your physical financial social and emotional well-being. Our benefits include but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on compensation and benefits will be provided during the recruitment process.

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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