(Senior) CMC Analytical Specialist

Genmab

Copenhagen, Denmark

As the (Senior) Analytical Specialist, you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA). You will work across project teams to support the CMC Project Managers and work closely with other specialists for e.g. upstream processing, downstream processing, and characterization as well as with relevant specialists within partner programs and areas.

Key Responsibilities Include

Responsible for the LSMD analytical strategy on ongoing projects.
Day to day oversight of analytical activities performed at partnered CMOs according to the latest industry standards and regulatory guidance.
Prepare/review technical documents including development/validation/transfer protocols and reports.
Author and review of CMC regulatory analytical submissions documents.
Work closely with characterization SME’s to develop late stage development analytical/characterization strategies.
Support defining/refining required processes for analytical/characterization activities.
5-10 days of travel per year are expected.

Requirements

Master’s degree in natural science, pharmacy, or similar.
At least 5 years of documented professional experience with analytical methods for GMP manufacturing, preferable from late stage development.
Thorough understanding of the detailed requirements for analytical validation and be up to date with current trends.
You preferable have active and recent experience within analytical development and validation of methods for biologics/monoclonal antibodies from a phase II/III program.
Experience with chromatographic and pharmacopeia methods for biologics is preferred, along with proficiency in other analytical techniques.
Familiarity with establishing and maintaining reference standards is also highly desirable.
It is also preferred that you have experience in preparing and reviewing relevant filing documentation for regulatory market authorizations (e.g. BLA, MAA, J-NDA).
Excellent communication skills in English written and oral.

About You

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
You are a generous collaborator who can work in teams with diverse backgrounds.
You are determined to do and be your best and take pride in enabling the best work of others on the team.
You are not afraid to 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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