Senior CMC Project Manager, Late-Stage Manufacturing

Senior CMC Project Manager, Late-Stage Manufacturing

Genmab

Copenhagen, Denmark

The Role & Department

Genmab is looking for a Senior CMC Project Manager to join our Late-Stage Manufacturing Development (LSMD) Team, which is responsible for process characterization, process validation activities, and submitting market authorization applications.

As a Senior CMC Project Manager, you will support the CMC Lead of one of Genmab’s late stage development programs and you will be responsible for the coordination and planning of activities performed at our partnered CMO’s.

Join our dedicated team of 30 professionals at LSMD and report directly to the LSMD Project Management Team Lead, in Copenhagen, Denmark.

Responsibilities

• Manage CMC activities at CMOs related to mAbs, small molecules and ADC manufacturing.
• Internal alignment in the CMC Management Team governing a CMC program within Genmab.
• Support authoring and reviewing of regulatory CMC submissions (BLA, MAA, JNDA).
• Support and follow up on CMO and internal quality events as e.g. changes or deviations.
• Support the maintenance of CMC Operations’ quality system.
• Secure clinical supply.

Requirements

• Master’s degree in relevant natural sciences.
• 8+ years of experience in biopharmaceutical, preferably with therapeutic monoclonal antibody or ADCs.
• 8+ years of experience in CMC project management.
• Proven track record and technical skills in biological process development/biopharmaceutical manufacturing.
• As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture, experience in running projects with external partners is preferred.
• Experience with the CMC technical sections of regulatory submissions and interacting with global regulatory authorities.
• Excellent communication skills in English and the ability to work in multicultural teams.
• Ability to work successfully under pressure in a fast-paced environment and with tight timelines.

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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