Project Manager CMC

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 and Department

The role provides CMC project management and technical support for late-stage drug product (DP) development projects. The position supports pharmaceutical development process characterization validation regulatory submissions and interactions with CMOs partners and regulatory authorities ensuring all activities are executed in compliance with Genmabs quality systems and regulatory requirements.

Key Responsibilities

• Provide CMC project management support for late-stage drug product development projects including pharmaceutical development activities for liquid and lyophilized drug products

• Act as the responsible project manager for assigned drug productrelated activities

• Support drug product process characterization and validation activities in accordance with regulatory requirements

• Support the development and execution of drug product activities required for regulatory filings in close collaboration with the Genmab late-stage organization

• Review and approve technical and quality documents from contract manufacturing organizations (CMOs)

• Assist with technical transfer activities between CMOs and external partners

• Support the authoring and review of CMC sections of regulatory submissions including IND/IMPD and BLA/MAA

• Support Regulatory Affairs in communications and interactions with health authorities

• Drive interactions with CMOs including follow-up on timelines and technical and quality topics

• Support internal and external inspections including inspections at CMOs

• Ensure all CMC activities are performed in compliance with Genmabs quality systems and applicable regulations

Requirements

• Minimum of a Masters degree in a scientific or technical discipline preferably Pharmaceutical Sciences Chemical Engineering or a related field

• An advanced degree and/or relevant professional certification within the area of Drug Product Development is preferred

• Minimum of 5 years of experience within the pharmaceutical biotechnology and/or medical device industry with demonstrated experience in the execution of drug product (DP) processes

• Proven track record of project management experience including planning execution follow-up and coordination of cross-functional teams of specialists

• The position has a strong focus on stakeholder management and requires strong communication skills and the ability to collaborate effectively across functions and cultures

• Experience working in a global organization and with external partners including CMOs could be considered an advantage

Key Competencies

• Strong understanding of late-stage CMC drug product process development as well as the manufacture of lyophilized and liquid products

• Strong team player who thrives and prioritizes working in a team while maintaining a strong stakeholder network

• Solid knowledge of regulatory requirements and quality systems

• Structured proactive and detail-oriented approach to project execution

• Ability to manage multiple stakeholders and priorities in a fast-paced environment

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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