(Senior) CMC Specialist, Upstream Processing, Lifecycle Management

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

Do you want to join a highly skilled Lifecycle Management(LCM) Subject Matter Expert (SME) team within MSAT CMC Operations and work closely with commercial and late stage activities in a stimulating international environment

With Genmabs continued growth we work with strong engagement to support our marketed and late stage products prepare high quality CMC packages for regulatory filings and ensure robust lifecycle management across our expanding portfolio. We are now looking for a (Senior) CMC Specialist Upstream Processing Lifecycle Management to join our journey and contribute with strong upstream expertise.

With strong drive and engagement you will join Genmabs growth journey and contribute with your upstream processing experience in a lifecycle management context. As the (Senior) USP SME for Lifecycle Management you will be responsible for upstream activities performed at Genmabs partnered CMOs and work across project teams to support the CMC Project Managers.

You will be part of Process Development in MSAT. Process Development is responsible for upstream downstream and drug linker processes and works closely with CMC Project Managers CMOs and cross functional SMEs to support late stage development commercial manufacturing and lifecycle management activities. The function currently consists of 15 people and is expanding. You will report to the Director Head of Process Development.

The position is based in Copenhagen Denmark.

Applications are reviewed on an ongoing basis.

Key Responsibilities

• Developing and maintaining late stage and commercial upstream processing strategies with a clear focus on lifecycle management of marketed and late stage assets

• Acting as the upstream processing SME for lifecycle management activities batch review process comparability continued process verification and global post approval changes

• Evaluation of process performance manufacturing trends deviations and change controls related to upstream processing

• Defining the scope of upstream development and lifecycle management activities with CMOs and partners in line with current industry standards regulatory expectations and project needs

• Overseeing upstream activities performed at partnered CMOs including troubleshooting and commercial process support

• Authoring and reviewing CMC regulatory submission documents responses to health authority questions and documentation supporting post approval changes

• Working closely with downstream processing analytical validation characterization quality regulatory CMC and manufacturing SMEs to align late stage and lifecycle management strategies

• Supporting the definition implementation and continuous improvement of internal processes related to upstream lifecycle management activities

Requirements

• Holds a degree in Life Science such as Biotechnology Biochemistry Pharmaceutical Sciences Chemical Engineering or another relevant fields

• For the CMC Specialist level the ideal candidate has at least 3 years of documented professional experience within upstream CMC preferably from late stage development commercial manufacturing support or lifecycle management

• For the Senior CMC Specialist level the ideal candidate has at least 7 years of documented professional experience within upstream CMC preferably with significant experience from late stage development commercial manufacturing support lifecycle management or regulatory CMC activities.

The successful candidate will have the following profile:

• Strong understanding of mammalian upstream processes including cell culture bioreactor operation process parameters raw materials scale up and process control strategies

• Knowledge of upstream process characterization risk assessment process validation process performance qualification and continued process verification

• Experience with lifecycle management activities including process optimization process comparability process monitoring deviation support change control and post approval changes

• Experience preparing and reviewing CMC documentation for regulatory submissions and market authorizations

• Preferred experience working with CMOs and external partners in a late stage or commercial manufacturing setting

• Strong written and oral communication skills in English

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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