Senior Specialist, CMC Analytical
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Senior CMC Analytical Specialist to join our Manufacturing Science & Technology (MSAT) organization within CMC Development & Manufacturing / Technical Operations.
In this role you will contribute to advancing our diverse biologics pipelinefrom early development through commercializationwith a particular focus on antibody-based modalities including bispecific antibodies and Antibody-Drug Conjugates (ADCs).
You will join a highly specialized CMC Analytical and Protein Characterization team working as a Subject Matter Expert in a collaborative matrix environment.
You will partner closely with:
CMC Project Managers.
MSAT colleagues across CMC Process Development CMC Stability CMC Pharmaceutical Development and CMC Writing.
Cross-functional stakeholders in Quality CMC Regulatory Product Development (our non-GMP CMC development lab in Utrecht NL) and Genmab QC (Ballerup DK).
External partners including Contract Manufacturing Organizations in a network across the globe (CMOs).
Your work will be central to ensuring robust analytical and characterization strategies enabling successful development regulatory submissions (BLA/MAA) and lifecycle management.
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.
Responsibilities
Lead and oversee analytical method strategies including development qualification validation transfer and lifecycle management.
Establish fit-for-purpose regulatory-aligned characterization packages across the biologics pipeline.
Provide scientific and technical oversight of analytical activities at CMOs.
Collaborate with Product Development (Utrecht) on non-GMP analytical activities supporting characterization and testing strategies.
Support analytical activities related to phase transitions process changes and site transfers.
Act as a trusted subject matter expert guiding analytical and characterization approaches from early-stage development through commercialization.
Drive the implementation of analytical and characterisation strategies across projects.
Author and review technical and regulatory documentation including contributions to BLA/MAA submissions.
Work cross-functionally to strengthen late-stage analytical strategies and processes.
Requirements
Masters degree in Science Pharmacy or a related field (PhD or additional qualifications are an advantage).
810 years of experience within CMC or a related area in the pharmaceutical or biotechnology industry.
Strong expertise in analytical validation and characterization including small molecule and biologics preferably from Antibody Drug Conjugate projects.
Experience with regulatory documentation and submissions (e.g. BLA MAA).
Excellent communication skills in English with the ability to engage effectively across functions and cultures.
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.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().
Required Experience:
Senior IC
Key Skills
About Company
Founded in 1999, we are an international biotech company committed to improving the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, our passionate, innovative and collaborative team has invented next-generation antibody technology platforms ... View more
