CMC Project Associate, Bioprocess Data System

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

The Role

As CMC Project Associate, Bioprocess Data System, you will work with 2 main tasks: 1) Bioprocess Data system support and 2) CMC Project support.

Supporting Bioprocess Data system: Genmab is currently taking a major digital leap on seamlessly integrating all bioprocess development and manufacturing data into one common data system. The Bioprocess Data System is planned to go life in the 1st half of 2022. You will be part of the team of CMC and IT specialists implementing the bioprocess data system at Genmab and will take over the responsibility for the bioprocess data system after the implementation phase, ensuring that current and new CMC programs are properly implemented and represented in the system.

In addition, you will support a CMC project manager in executing CMC projects within the Genmab portfolio and you will work on 1-2 antibody pipeline programs in the Early-Stage CMC Team. During Early-Stage CMC development from DNA to First-in-Human GMP manufacture, you will work together with a CMC PM to thrive selected tasks. This could for example be related to process development and manufacture of biopharmaceuticals. You will also perform quality related tasks required to support CMC development (for example handling of change requests and deviations). You will assist the CMC PM to develop and update project plans, assist with budget tasks, and support the CMC PM for internal project governance.

CMC Operations currently consists of approx. 55 people and you will report to the Senior Director CMC, Head of New Product Introduction.

Responsibilities

The key responsibilities include, but are not limited to:

Support the implementation of the Bioprocess Data System and maintenance of the system after go-live

Support the CMC Project manager in development activities from DNA to IND/CTA and further CMC development until clinical proof of concept

Managing CMC activities at CMOs for selected task

Member of the CMC Management Team governing a CMC program internally

Reviewing or authoring specific sections of CMC submissions

Support CMC PM on budget oversight, project planning and internal governance

Maintenance of CMC Operations’ quality system as e.g. update/review SOPs and handling of changes or deviations.

Requirements

You have a relevant bachelor or master’s degree in natural or engineering sciences, with 1-3 years working experience of biological process development and/or biopharmaceutical manufacturing.

Alternatively, you have been working as technician in the bioprocess industry for at least 5 – 8 years and prove to have excellent understanding of bioprocess development/manufacturing.

Basic skills to understand the aspects of antibody manufacture ranging from cell line, assay and process development through pilot and GMP manufacturing. Good understanding of the primary unit operations typically used in the biotech industry.

Basic knowledge of the related GMP and regulatory requirements.

As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture of investigational drugs, experience in running projects with external partners is a merit.

Experience with Process Data Management System management as e.g. Skyland PIMS, Biovia Discoverant, Genedata Bioprocess or Osisoft PI and basic data base skills in e.g. SQL would be an asset.

Experience with other softwares typically used in the bioprocess industry as e.g. DeltaV, Unicorn, BioPAT are supportive of the position

Fluency in English.

Moreover, you meet the following personal requirements:

You find it comfortable to work in an agile biotech environment contributing to the overall success of Genmab

You are curious and like to challenge existing processes

You are able to work independently and can find solutions without the need for detailed guidance by peers or superiors

You have a quality mindset

You are a quick learner and are not afraid in taking on new tasks where you have no or little prior experience

You can prioritize your work in a fast paced and changing environment

You can make decision independently and understand when you need to involve internal and external stakeholders to verify these

You thrive in cultural diversity

You are good at building solid professional relations to internal and external collaborators.

If you would like additional information about this position before applying using the link, please contact Senior Talent Acquisition Manager, Jannie Jensen,

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website .

Genmab

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